Regulatory Landscape for Raw Materials: CMC Considerations
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Regulatory Landscape for Raw Materials: CMC Considerations
A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients globally. With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Therefore, there is an increasing need to implement a harmonized regulatory infrastructure that is both flexible and predictable to provide more...
Figure 1: Redundancies in the postapproval change management process contribute to delayed approval.
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Streamlining Postapproval Submissions Using ICH Q12 & SCDM
Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. Incorporating concepts and tools from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q12 guideline, combined with structured content and data management (SCDM) and a cloud-based data exchange...
Is a Globally Harmonized Quality Overall Summary Possible?
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Is a Globally Harmonized Quality Overall Summary Possible?
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline on Registration of Pharmaceuticals for Human Use (M4)1
  • 1International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality–M4Q (R1)...
From Data to Knowledge Management: What to Consider
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From Data to Knowledge Management: What to Consider
Although data and knowledge are both stand-alone disciplines that need to be systematically managed, they also must have a connection. Understanding the relationship between data and knowledge management processes and how people are leveraging advances like Pharma 4.0™ combined with these processes enables quality data transition to knowledge that can help pharmaceutical companies. The authors...
Effective Knowledge Management in Mergers and Acquisitions
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Effective Knowledge Management in Mergers and Acquisitions
As the pharmaceutical industry continues to grow and evolve, a significant contributor to innovation and evolution is mergers and acquisitions (M&A). M&A can enable academic researchers and small companies to fund and commercialize innovative products. In addition, M&A can help larger organizations secure new and complementary technology and products. In the pharmaceutical...
Knowledge Centers Improve Knowledge Capture and Sharing
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Knowledge Centers Improve Knowledge Capture and Sharing
As the industry experiences significant changes to the way we do business, knowledge capture and sharing are more important now than ever before. The maturing digitalization of the biopharma industry’s business and processes is creating an increasingly data- and information-rich environment that requires more effective mechanisms for sharing data and information. The Knowledge Management team...
Integrating Knowledge Management and Quality Risk Management
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Integrating Knowledge Management and Quality Risk Management
ISPE held an Expert Xchange on 18 January 2022 entitled “Risk-Based Decision Making: Advancing the Integration of Quality Risk Management (QRM) and Knowledge Management (KM).” The session included presentations and interactive exercises that generated new and useful insights into the current effectiveness of the knowledge that flows into QRM and how a knowledge map can be used to diagnose...
Reimagining CPV for a Pharma 4.0™ World
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Reimagining CPV for a Pharma 4.0™ World
The life cycle approach to process validation stresses the need for continued monitoring of process performance to ensure that the manufacturing process remains stable and predictable, i.e., in a state of control. This life cycle stage is known as continued process verification (CPV) or ongoing process verification (OPV).1
  • 1US Food and Drug Administration Center for Drug Evaluation...
FOYA Winners Share Lessons Learned in Facilities Development
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FOYA Winners Share Lessons Learned in Facilities Development
What do recipients of ISPE’s prestigious Facilities of the Year Award (FOYA) know that has helped their projects succeed? What are the lessons learned from achievements in facilities development, including forward-looking projects that encompass and inspire changes in the industry? Pharmaceutical Engineering® spoke with nine FOYA winners from recent years about the lessons they learned and...
Viral Vector Platforms: Intersection of Facility and Program
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Viral Vector Platforms: Intersection of Facility and Program
Realizing the promise of any novel viral vector therapeutic depends on the innovator’s ability to constantly meet evolving program requirements set in the product’s preclinical; clinical; chemistry, manufacturing, and controls (CMC); and market strategies. A key enabler to success is establishing a robust yet nimble viral vector manufacturing platform that delivers high-quality product on time...
Figure 1: Key characteristics of the ISO/IEC 25010:2011 product quality model
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Quality Agreements for SaaS Solutions Intended for GxP Use
As adoption of cloud technology continues to increase across the life sciences industry, so too does the need to establish a standardized and pragmatic approach for ensuring the quality of software applications used in support of GxP data and associated processes. This article focuses on the application level and the growing use of software as a service (SaaS) within the life sciences...
Maturity model
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AI Maturity Model for GxP Application: A Foundation for AI Validation
Artificial intelligence (AI) has become one of the supporting pillars for digitalization in many areas of the business world. The pharmaceutical industry and its GxP-regulated areas also want to use AI in a beneficial way. Several pharmaceutical companies are currently running digital pilots, but only a small fraction follows a systematic approach for the digitalization of their operations1
GAMP® Considerations When Relying on Open-Source Software
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GAMP® Considerations When Relying on Open-Source Software
This article aims to refresh information on open-source software (OSS) within regulated computerized systems that was first discussed in an article in May-June 2010 Pharmaceutical Engineering®. The adoption of OSS advanced since then, and the article explores the importance of recognizing when an organization is relying on OSS and the benefits and risks this brings from a GAMP® 5...
Figure 3: Industry develops a single global control strategy.
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Toward a Single Global Control Strategy: Industry Study
During the past decade, industry has experienced a proliferation of regulatory divergence regarding the interpretation and implementation of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines (and control strategies) across geographic regions. This article shares data that highlight instances where well-established ICH...
Figure 3: Adoption time in years experienced by nonpharmaceutical and pharmaceutical industries since the technologies were invented/discovered.
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Measuring Pharma’s Adoption of Industry 4.0
With the rise of new technologies and predictive analytics capable of handling the huge amounts of data within and across existing information systems, Industry 4.0 has been thriving in many sectors, such as industrial automation, financial technology, retail, and semiconductors. But the health sector in general,1
  • 1Singh, P., S. N. Singh, and L. Ram. “Health 4.0: Role of Health...
Figure 1: The 4 Ps of the pharmaceutical value chain are interconnected. Each element finds its virtual representation in a digital twin (figure © Zeta).
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Driving Biopharma Solutions with Digital Technologies
Developing comprehensive digital solutions is crucial for the entire value creation process for pharmaceuticals. A holistic view of the interrelations of product, production process, and plant is becoming increasingly significant. In this context, the application of model-based technologies provides support in drug development, process scale-up, and manufacturing. Furthermore, it accelerates...
Emerging Leaders Cover
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Emerging Leaders: Nurturing Emerging Talent & the Workforce of the Future
Emerging Leaders has grown from an initiative for interactions among early-career professionals entering ISPE into much more: a training ground, a networking organization, and a new foundation for the future of ISPE and the industry. This article looks at the history of the group, its purpose, current and future initiatives, and a name change that better reflects the path of its members.
AI’s Promise for ATMPS - C0ver Image
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AI’s Promise for ATMPs
Industry 4.0 applications in biopharma involve the complete spectrum of data science throughout the entire product life cycle of many disparate entity types. Tools such as digitalization, modern data science, and the industrial internet of things (IIoT) exist now, and examples from other industries such as Siri and Alexa, face identification, and self-driving cars can guide their...
Comparison between autologous therapies and allogeneic therapies
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Supporting Scalable Cell Therapy Using Allogeneic Workflows
Historically, cell therapies are used to treat patients with cancer after relapse from other approved treatment modalities, or if no approved treatment is available. However, the introduction of allogeneic cell therapies has created exciting opportunities to broaden access to cell-based treatments. With advancements in manufacturing, developers are becoming increasingly interested in...
Changing Lives with Gene Therapies
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Changing Lives with Gene Therapies
The process of bringing new drugs and products to market requires creativity, thinking outside the box, and the courage to fail numerous times before making a single discovery. This rings especially true now, as the industry faces the COVID-19 pandemic and doubts about vaccines and therapies getting to market in record time to improve human health. This article presents a deep dive into gene...
Figure 1: The data continuum touches every aspect of the patient experience.
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Personalized Medicine: The Industry’s Future
With so many options for personalizing our lives, is the personalization of medicine far behind? With all the data available, how can the industry bring personalized medicine to patients? This article explores what is currently available and where the pharmaceutical industry can move forward to better serve patient needs.
Figure 2: Setting a risk-based CQV plan
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Today’s Pharma and Biotech Projects: A Phased Approach
This article revisits the concept of phased engineering, procurement, and construction (EPC) and updates it with risk-based considerations specifically regarding the commissioning, qualification, and validation (CQV) of general life-cycle principles for pharma and biotech projects. Enhancing the relationship between phases of a project, advanced planning, and more formal management of...
Submission and review process diagram
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ICH Quality Guidelines: Present Initiatives & ISPE Involvement
In its 30-year history, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has covered a wide range of topics to generate quality, safety, efficacy, and multidisciplinary harmonized guidelines. As science advances, issued guidelines are being updated and new guidelines are proposed in a pipeline of potential future activity. This...
A Vision for ICH Q12: Current Experience, Future Perspectives
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A Vision for ICH Q12: Current Experience, Future Perspectives
Management of global postapproval chemistry, manufacturing, and controls (CMC) changes is a growing challenge for industry with many issues. ICH Q12 (Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management) is a transformative document shaping global regulatory postapproval submissions that will help alleviate some of these issues.
Continuous Manufacturing as a Tool for Accelerated Development
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Continuous Manufacturing as a Tool for Accelerated Development
Continuous manufacturing (CM) offers one way the pharmaceutical industry can accelerate development of the drug product control strategy to ensure a robust and reliable supply of medicine to the clinic and/or market. This article explores the promise of continuous manufacturing in enhancing accelerated development, as evidenced by experience in solid oral products.
Regulatory Aspects of Global Acceptance of Continuous Manufacturing
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Regulatory Aspects of Global Acceptance of Continuous Manufacturing
Application of continuous manufacturing (CM) in the pharmaceutical industry is gaining momentum. Most of the current experience is based on oral solid dosage (OSD) projects but in the future continuous manufacturing should not be limited to these dosage forms. In this article, the regulatory acceptability of continuous manufacturing to produce pharmaceuticals is demonstrated in different...
Continuous Manufacturing Good Practice Guide Is Planned
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Continuous Manufacturing Good Practice Guide Is Planned
The ISPE OSD Community of Practice Continuous Manufacturing Subcommittee is planning a Good Practice Guide to capture information developed over several years by the team to establish equipment requirements, identify opportunities for harmonization and flexible integration, and suggest where current equipment may be enhanced to work with continuous manufacturing platforms of the future.
Navigating the Life Cycle for Cell & Gene Therapies
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Navigating the Life Cycle for Cell & Gene Therapies
Cell and gene therapies are complex. As more therapies come to market in the hope of bringing advanced treatments and cures to rare, orphan, and difficult-to-treat diseases, designing quality standards for these personalized medicines is equally as complex.1
  • 1European Commission. EudraLex, Volume 4: EU Guidelines for GMPs for Medicinal Products for Human and Veterinary Use. Part 4:...
Opportunities in Continuous Manufacturing of Large Molecules
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Opportunities in Continuous Manufacturing of Large Molecules
Continuous manufacturing has attracted significant interest over the past decade for small molecules formulated as drug products. The case for adopting continuous manufacturing platforms for manufacturing biologics (i.e., large proteins or biologic products such as vaccines) would, in principle, be even more justified for both quality and business gains. This article briefly reviews continuous...
Effect of Industry 4.0 enablers on the product life cycle.
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Data Science for Pharma 4.0™: Drug Development, & Production—Part 2
This second of a two-part series explores digital transformation and digitalization in the biopharmaceutical industry with information about how data science enables digitalization along the product life cycle. (Part 1 was published in the March-April 2021 issue of Pharmaceutical Engineering.1
  • 1Herwig, C., et al. “Data Science for Pharma 4.0™, Drug Development, and Production—Part...
Functional interface overview.
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Cloud Computing Implications for Manufacturing Execution Systems
Cloud computing can be described as networked access and utilization of configurable computing resources such as data and information storage, processing capabilities, applications, and other services on computerized systems provided and/or maintained by a remote organization. As life sciences companies consider the advantages and costs of utilizing cloud services, they first need to invest...
Best Practices for Deploying Real-World Evidence Solutions
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Best Practices for Deploying Real-World Evidence Solutions
Real-world evidence (RWE) is clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data (RWD) relating to patient health status and the healthcare delivery.1
  • 1US Food and Drug Administration. “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food...
IT Services: Applying Good IT Practice & Automation
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IT Services: Applying Good IT Practice & Automation
This article focuses on pragmatic quality- and risk-based approaches to IT infrastructure. It covers recommendations made by a US FDA/industry team linked to the US FDA Center for Devices and Radiological Health (CDRH) Case for Quality initiative1
  • 1US Food and Drug Administration Center for Devices and Radiological Health. “Case for Quality.” 29 July 2020.
ISPE Pharma 4.0™ SIG & Its Working Groups
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ISPE Pharma 4.0™ SIG & Its Working Groups
The ISPE Pharma 4.0™ Special Interest Group (SIG) launched in 2015 to provide a road map for new challenges of digitalization, Industry 4.0, and the smart factory. The Special Interest Group addresses how pharmaceutical industry stakeholders, including regulatory authorities, can achieve benefits from
The holistic supply chain
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Holistic Control Strategy: From ICH Quality Guidelines to Pharma 4.0™
The fourth Industrial Revolution (also known as Industry 4.0) is the era of smart machines, storage systems, and production plants that can autonomously exchange information, trigger actions, and control operations free of any human intervention. To ensure future success in the delivery of therapeutic medicines to patients, it is imperative that the pharmaceutical industry move deeper into the...
Effect of Indutry 4.0 enablers on the manufacturing process chain. Upper arrow: Conventional approach. Lower arrow: Perceived extended process chain using IIoT enablers.
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Data Science for Pharma 4.0™, Drug Development, & Production—Part 1
Digital transformation and digitalization are on the agenda for all organizations in the biopharmaceutical industry. But what are the main enablers of intelligent manufacturing? We hypothesize that data science–derived manufacturing process and product understanding is the main driver of digitalization in the bioprocessing industry for biologics manufacturing. In this article, the first of a...
The History & Future of Validation
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The History & Future of Validation
Across every industry today, digitalization is driving the use and value of data to disrupt traditional business models and ways of working. In pharmaceuticals, the promises of Industry 4.0 are expected, and needed, to finally modernize the legacy approaches that have evolved since the 1970s. Validation is an obvious target for digital disruption because of the inefficient, document-heavy...
Creating Effective Standard Operating Procedures
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Creating Effective Standard Operating Procedures
Personnel management is the most challenging variable in maintaining current Good Manufacturing Practice (cGMP) across the life cycle of drug manufacture, safety, and supply. A standard operating procedure (SOP) outlines agreed-upon instructions for personnel training and instructions for maintaining systems, machines, documents, and records in a qualified state to produce safe products. This...
Model-Informed Drug Development Addresses COVID-19 Challenges
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Model-Informed Drug Development Addresses COVID-19 Challenges
Drug developers know that the odds of anyone compound demonstrating safety and efficacy for a disease and its affected populations are low. How can drug developers improve these odds and increase the efficiency and effectiveness of drug development? One useful tool is model-informed drug development (MIDD), which uses computer models to inform the design of clinical trials or to run...
Joydeep Ganguly
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Industry Leaders: Focused on the Mission
Joydeep Ganguly, who is currently Senior Vice President, Corporate Operations, at Gilead Sciences, Inc., places a premium on working for a mission-oriented company. “If you choose the right company with the right ethos and a deep, tangible commitment to the patients, the mission is not just rhetoric,” he said. “You see it in the way they do things. If you work for a company that makes that...
Figure 1: CNN model training process and validation results for a lyophilized vial AVI system.
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Vision Inspection Using Machine Learning/Artificial Intelligence
Pharmaceutical companies rely on automated vision inspection (AVI) systems to help ensure product safety. Although these systems overcome challenges associated with manual inspection, they can be hindered by limitations in their programming—if the system is programmed to consider every variation in inspection conditions, it is likely to falsely identify defects in safe products. This article...
Plenary session at the 2019 ISPE Europe Biotechnology Conference in Brussels in September 2019.
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2019 ISPE Europe Biotechnology Conference: Industry Transformations
As biopharmaceuticals have become a major part of the pharmaceutical industry, we have witnessed significant transformations in product development, strategy, technology, and operations. This ongoing transformational process was the main theme of the fourth annual
Current State of Oligonucleotide Therapeutics
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Current State of Oligonucleotide Therapeutics
Oligonucleotides are a relatively new class of drugs, composed of natural and synthetic nucleotides, which primarily include small interfering RNA (siRNA), micro RNA (miRNA), and antisense oligonucleotide (ASO). These molecules achieve therapeutic effects through RNA interference, degradation, or splice-modulating pathways.1
  • 1Weng, Y., H. Xiao, J. Zhang, X. J. Liang, and Y. Huang....
Figure 1: Cell therapy life cycles.
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Flexible Facility Design for Multiple Cell Therapy Processes
In many critical ways, the design of facilities for multiple cell therapy processes is unlike the design of conventional pharmaceutical facilities. This article surveys several of the key issues to consider when designing facilities capable of manufacturing multiple cell therapies, including regulatory definitions, product life cycles, processing systems, relevant cell therapy technologies and...
Figure 1: A global supply scenario with cross-country and cross-cultural interfaces
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Operational Risk Management in Global Supply Scenarios
The current regulatory framework in the pharmaceutical industry places pressure on marketing authorization holders (MAHs) to demonstrate quality oversight, and a systematic risk management process is a prerequisite for avoiding compliance and productivity pitfalls. This article focuses on options to improve day to- day operations and to ease decision-making by integrating operational risk...
Cell & Gene Therapy Facility Design Using Simulations
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Cell & Gene Therapy Facility Design Using Simulations
Designing new facilities for cell and gene therapy manufacturing is a challenging task given the many uncertainties in this industry sector, including varying potential demand for any given new therapy, evolving platforms and technology, questions about equipment reliability, learning curves for analysts and operators, possible sourcing issues, and variable lead times for key raw materials....
Validation of Clinical Trial–Related Systems in Smaller Enterprises
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Validation of Clinical Trial–Related Systems in Smaller Enterprises
Existing risk-based approaches to computerized system compliance and validation as outlined in GAMP® 51  are applicable to a variety of life sciences organizations...
  • 1International Society for Pharmaceutical Engineering. GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems. North Bethesda, MD: International Society for Pharmaceutical Engineering, 2008.
Technology Trends: The Transition to Digitalization
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Technology Trends: The Transition to Digitalization
In the pharmaceutical industry, digitalization involves developing and implementing digital technologies at all levels of pharmaceutical operations. The aim is to transform the industry by capturing, analyzing, and using vast amounts of data collected from a wide range of sources to support research and development (R&D), clinical development, drug manufacturing, supply chain management,...
Reporting categories for changes in the drug substance (DS) and drug product (DP) process and analytical methods per FDA guidance [
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Case Study: Facilitating Efficient Life-Cycle Management via ICH Q12
The latest ICH guideline, ICH Q12,1
  • 1International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “ICH Harmonised Guideline: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. Q12. Final Version.” 20 November 2019.
Achieving Vertical & Horizontal Integration in Pharma 4.0™
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Achieving Vertical & Horizontal Integration in Pharma 4.0™
Recent projects on serialization and track and trace help illustrate the concepts of vertical and horizontal integration. With vertical integration, the unique product identification information (serial number, lot, etc.) used by sensors and printers on the packaging lines is made accessible to the supply chain and regulatory hubs throughout the entire technology stack. With horizontal...
Tracking the Journey of Barrier Technology
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2020 ISPE Barrier Survey: Tracking the Journey of Barrier Technology
For over two decades, the ISPE Barrier Isolator Survey has gathered meaningful data on the applications of barrier technology and been a resource for the fill-finish pharmaceutical industry community. This article provides context for the latest survey, the first in several years, and presents its key results, which were first shared at the
Pam Cheng
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Industry Leaders: Mission-Driven Leadership
Pam Cheng is Executive Vice President, Global Operations & Information Technology, at AstraZeneca, a United Kingdom–headquartered pharmaceutical company with more than 60,000 employees. In this role, she combines her expertise as an engineer with business savvy and seeks opportunities to lead her company and her industry forward in innovative ways.
Wearable Devices & Biometrics Improving Efficiency in GxP Operations
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Wearable Devices & Biometrics Improving Efficiency in GxP Operations
As the old saying goes, “Time is money.” In today’s industrialized world, this adage is profoundly true. Manufacturers can no longer afford to overlook operational excellence. A new production philosophy called “Lean manufacturing” has been developed to save as much time as possible during manufacturing processes. In some industries, such as the automotive sector, Lean has almost been...
Update from the ISPE Regulatory Steering Council
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Update from the ISPE Regulatory Steering Council
Virtually every ISPE member has at least one story to tell about how health authority inspections or the review and approval of regulatory applications have affected their efforts to supply critically needed medications to patients globally. Although these stories may emphasize the considerable challenges that ISPE members face, they also frequently identify great opportunities for innovation...
Article
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ISPE Comments to the Annex 2 PIC/S Draft Revision
Annex 2 is the Good Manufacturing Practices (GMP) document by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) addressing manufacture of biological medicinal substances and products for human use. This article shares information about Annex 2 and ISPE’s submitted comments to the draft revision of Annex 2 that was released for public consultation in September 2019.
ICH Q12: A Transformational Product Life-Cycle Management Guideline
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ICH Q12: A Transformational Product Life-Cycle Management Guideline
On 20 November 2019, the ICH Assembly endorsed the Q12 guideline, “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management,” at its biannual meeting in Singapore. This transformational guideline has a wide scope of applicability across pharmaceutical drug substances and products (both chemical and biological), drug-device combination products that meet the...
A Gamp® Approach to Robotic Process Automation
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A GAMP® Approach to Robotic Process Automation
This article introduces the concept of robotic process automation (RPA) and discusses how the technology may be used within a GAMP® framework to support both non-GxP and GxP processes.
Sustainability & the Life Sciences Industry: A Global Introduction cover
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Sustainability & the Life Sciences Industry: A Global Introduction
In this issue of Pharmaceutical Engineering®, we address an array of sustainability topics. This article surveys topics that will likely have a significant global impact on the way we conduct our business over the coming decade. We trace some history of sustainability in the life sciences industry and identify future issues of concern, including a number of areas...
Company A energy audit summary (annual carbon savings by utility category).
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Two Real-World Experiences in Global Sustainability
The article appraises the real-world experiences of two pharmaceutical companies approaching the rollout of energy- and water-reduction programs to selected facilities around the world. It is the result of more than two years of collaboration between the company corporate teams, individual site teams, and an external specialist consultant.
Figure 2: Energy Venn diagram (per I.S. 399) and filter dryer example.
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Implementation of a Formal Energy-Efficient Design Process
Sustainability is a key principle for pharmaceutical companies in 2020. However, translating corporate goals into meaningful improvements can be a challenge, particularly when competing factors such as complex technical requirements or ambitious project schedules are involved.
Figure 1: Sources of pharmaceuticals in the environment. Adapted from reference
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Industry Perspective: Bioremediation of Pharmaceuticals
Medical treatments and pharmaceuticals are indispensable in improving quality of life. In recent years, however, pharmaceutical compounds have become a significant group of environmental pollutants, shown to pose risks to human health and have adverse environmental effects.
Introducing Industry Leaders
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Introducing Industry Leader Profile Articles
With the start of the new year, Pharmaceutical Engineering® is launching a new series of profiles of industry leaders. This ongoing series will look at the lives and careers of individuals who are changing the face of the pharmaceutical industry.
Industry Leaders: An Advocate for Quality - Ranjana B. Pathak
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Industry Leaders: An Advocate for Quality
Ranjana B. Pathak, BSc (Hons), MBA, DHA, has spent nearly 40 years in the pharmaceutical industry. Currently the President and Global Head of Quality, Medical Affairs, and Pharmacovigilance at Cipla Ltd. in Mumbai, India, Pathak’s long tenure has afforded her an informed perspective on the past, present, and future of the industry. An active member of the
Industry Leaders: Bringing Pharma 4.0™ Into the World - Christian Wölbeling
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Industry Leaders: Bringing Pharma 4.0™ Into the World
Every important cause needs its champion. Champions have a vision of how things should be, and a passion to reach their goals. They are committed and determined to achieve positive results, are willing to do the heavy lifting, and will take consistent and massive action until results are achieved.
Biotech Industry’s Quest for Optimized Manufacturing Facility Design
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Biotech Industry’s Quest for Optimized Manufacturing Facility Design
Since the early 1990s, when the “upstart” biotech industry realized that its future success would be heavily influenced by the ability to manufacture multiple products within the same facility,1  the quest for flexible...
  • 1Hill, D., and M. Beatrice. “Biotechnology Facility Requirements, Part 1, Facility and Systems Design.” BioPharm International 2, no. 9 (1989): 20–6.
Figure 2: ISPE Pharma 4.0™ operating model
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Applying Holistic Control Strategy in Pharma 4.0™
Applying emerging technologies can lead to more robust and flexible manufacturing processes that in turn can help the pharmaceutical industry respond to drug shortages, reduce interruptions in production and delivery of medicines, ensure consistent clinical performance of products, and achieve other benefits. Although some may believe that regulators are averse to the use of emerging...
Figure 2: Steps in a holistic cleanroom concept.
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A Holistic Cleanroom Concept: Higher Quality & Greater Flexibility
As the pharmaceutical industry balances demands for small-batch and blockbuster products and encounters new regulations, there is a need for efficient and safe production technologies that can meet stringent quality and safety requirements for the aseptic filling of drugs. Looking forward, manufacturers should anticipate future format, packaging, and filling needs, and seek technologies with...
Industrializing New Platforms
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Industrializing New Platforms
Moving platforms from development to the delivery of more biopharmaceuticals to more patients is reality, not just a concept, for Moderna, Inc. Juan Andres, the company’s Chief Technical Operations and Quality Officer, presented on “mRNA Medicines—Industrializing a New Platform” at the
Why ISPE GAMP® Supports the FDA CDRH: Case for Quality Program
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Why ISPE GAMP® Supports the FDA CDRH: Case for Quality Program
The US FDA Center for Devices and Radiological Health (CDRH) Case for Quality program promotes a risk-based, product quality–focused, and patient-centric approach to computerized systems. This approach encourages critical thinking based on product and process knowledge and quality risk management over prescriptive documentation-driven approaches.
Cell and Gene Therapies and Their GMP Requirements
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Cell and Gene Therapies & Their GMP Requirements
Cell and gene therapies are the latest revolution in medicine manufacturing. Unlike small molecules or traditional biotech products, these therapies introduce cells and genes into a patient to treat the underlying cause of a disease—they are living medicines.
Risk Management in Single-Use Technology
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Risk Management in Single-Use Technology
Risk management is pervasive throughout the biopharmaceutical industry. It is an important factor during the implementation of new equipment or procedures into an operation. Likewise, risk management is also key when assessing the impact of changes. When doing a root cause analysis, evaluation of the risks becomes central to define the potential solutions to the problem analyzed and to...
Accelerated Pharma Product Development, Registration, Commercialization & Life Cycle
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Accelerated Pharma Product Development, Registration, Commercialization & Life Cycle
This article is Part 1 of a two-part series exploring what we can learn from examples of pharmaceutical products being approved using accelerated programs. The series focuses on challenges that chemistry, manufacturing, and control (CMC) development teams may encounter when a project is given accelerated development status. Part 1 introduces key considerations and themes in general terms and...
Application of SOC 2+ Process to Assessment of GxP Suppliers of Services
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Application of SOC 2+ Process to Assessment of GxP Suppliers of Services
To facilitate the assessment and mitigation of compliance risks associated with a third-party service organization, its services, and the systems used to provide the services, this article proposes adopting an approach from the financial sector that, with a little modification, could be used to assess suppliers of GxP-regulated IT services.
Improving Pharmaceutical Connections with Patients cover
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Improving Pharmaceutical Connections with Patients
Being on the cutting edge of drug development is the goal of most pharmaceutical companies, but a new drug won’t work if the patient doesn’t take it. It’s a vexing problem that developers of healthcare technologies hope to address.
Holistic Control Strategies for Continuous Manufacturing
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Holistic Control Strategies for Continuous Manufacturing
Innovative technologies such as continuous manufacturing (CM) bring speed, efficiency, and agility to pharmaceutical manufacturing together with enhanced process robustness and assurance of product quality. During CM, material is simultaneously charged and discharged into process unit operations. Similar to batch manufacturing, CM requires a comprehensive and holistic control strategy...
Serialization model
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Ten Frequently Asked Questions about Serialization
To meet the EU serialization deadline on 9 February 2019, pharmaceutical companies and their contractors have had to reorganize their manufacturing lines and logistics to ensure compliance with the EU’s Falsified Medicines Directive (FMD) of 2011 and the EU Commission Delegated Regulation 2016/161 of 2016. Worldwide, other anticounterfeiting regulations are already in place or coming soon in...
Continuous Manufacturing cover
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Regulatory Progress - Global Advancement of Continuous Manufacturing for Pharma
Continuous manufacturing (CM) is an advancement in pharmaceutical manufacturing technology that provides high assurance of product quality as well as enough flexibility and agility in production to respond to market demands. The decision to invest in CM can be challenging for a company given the cost of purchasing the continuous equipment, the resources and expertise required for additional...
Identifying Global Themes in Clinical Study Participants’
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Identifying Global Themes in Clinical Study Participants’
This article examines patient preferences in one facet of clinical research: the experience related to the use of investigational medicinal products (IMPs). As patients have become more involved and informed in their healthcare choices, the “voice of the patient” has been increasingly incorporated into the drug development process. Given that the success of a clinical study relies on the...
Data Integrity: A Vertical Journey Banner
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Data Integrity: A Vertical Journey
Data is an important factor that is reshaping the pharmaceutical industry and triggering significant innovation. Vertical integration of equipment can represent an optimal solution to manage the increasing flow of data efficiently, innovate the manufacturing environment, and fulfill data integrity requirements. Regulators and health agencies are strongly enforcing data integrity related...
Eye on the Future -banner image
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Eye on the Future - Janssen Expands Ireland Production Facility
Janssen is in the midst of a multimillion-dollar expansion project at the company’s Ringaskiddy, County Cork, manufacturing facility in Ireland. The 19,100-square-meter project is expected to significantly increase Janssen’s global manufacturing capacity for producing biologic medicines for multiple myeloma, rheumatoid arthritis, and Crohn’s disease.
Singapore - Biopharma’s Global Hub - ISPE Pharmaceutical Engineering Magazine
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Singapore - Biopharma’s Global Hub
Our May-June cover story on the rise of biopharmaceutical manufacturing in Asia noted that “Biopharmaceuticals are booming … buoyed by enhanced regulations, an influx of venture capital, a culture of innovation, and government support.”1 While...
  • 1Fotheringham, S. “The Rise of Biopharmaceutical Manufacturing in Asia.” Pharmaceutical Engineering 38, no. 3, (May-June 2018): 10–13.
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A Culture of Innovation
A corporate culture that supports creative thinking can help pave a road to innovation. Free people from fear and encourage them to do their best and you’ll have an environment for accomplishing great things, according to George Scangos, who has led Biogen and other pharma companies. In a recent conversation with PE, Scangos shared his approach to building a culture of innovation and provided...
In-Line, Real-Time Powder Flow & Process Monitoring - Bottles
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In-Line, Real-Time Powder Flow & Process Monitoring
Innovative technology for in-line real-time powder flow monitoring based on drag force flow measurement offers great potential for efficient monitoring of powder-processing operations.
The Magic of Discovery: Genentech's Futurelab changes education in South San Francisco - Science
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The Magic of Discovery: Genentech's Futurelab changes education in South San Francisco
For the jobs of tomorrow, STEM fields—science, technology, engineering, and mathematics—are powerful economic competitiveness drivers: 80% of the fastest-growing occupations depend upon mastery of math and science, and 92% of traditional STEM jobs require at least some post-secondary education and training. But in the United States, almost 50% of students have lost interest in the...
Digital Labels Revolutionize Investigational Medicinal Products (IMPs)
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Digital Labels Revolutionize Investigational Medicinal Products (IMPs)
Labeling is an important part of the supply chain. This is especially true for investigational medicinal products (IMPs), which must be labeled with clear expiry dates and other mandated information. IMP shelf life is notoriously difficult to quantify, however, and new findings on their stability frequently emerge during clinical trials. This often requires companies to relabel IMPs with...
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Blockchain: The Next Big Distruptor in Clinical Trials?
The digital revolution is driving change across all industries. With its ability to increase transparency and trust between parties, the recent innovation called blockchain has the potential to significantly disrupt the clinical trials industry.
The Fourth Industrial Revolution
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The Fourth Industrial Revolution
Dr. Enno de Boer says rapid, major changes are on the horizon for just about everything—including manufacturing.
Supply Chains Dramatic Changes Ahead
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Pharma Supply Chains: Dramatic Changes Ahead
Biopharmaceutical supply chains are undergoing dramatic changes that will affect the design and operation of the facilities of the future. Predominant among these is the shift away from primary care to specialty products and personalized medicine, and from large-scale production of low-value small molecules to low-volume, high-value biologics.
Continuous Manufacturing Current Status
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Continuous Manufacturing Current Status
Change in the pharmaceutical industry is notoriously slow, so it wasn't surprising that many doubted continuous manufacturing (CM) would ever be adopted. But despite the skeptics, the technology is gaining substantial ground. Since 2015, four solid oral drugs produced by continuous processes have been approved by the US Food and Drug Administration (FDA) (Table A).
The Advent of Continuous Manufacturing - ISPE Pharmaceutical Engineering
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The Advent of Continuous Manufacturing
Spurred by pressure from governments and consumers to curb rising drug prices, pharmaceutical manufacturers are increasingly willing to look beyond traditional batch processing to cut costs and increase efficiency. One of the industry's most dramatic innovations on this front is continuous manufacturing (CM). The technology, which produces drugs in an uninterrupted process, benefits...
The Rise of Biopharmaceutical Manufacturing in Asia - ISPE Pharmaceutical Engineering
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The Rise of Biopharmaceutical Manufacturing in Asia
Biopharmaceuticals are booming in Asia, buoyed by enhanced regulations, an influx of venture capital, a culture of innovation, and government support. Asian pharmaceutical manufacturing has traditionally focused on generics, but things are changing.1
  • 1Liu, A. "AstraZeneca Allies with Alibaba and Tencent as Its China Sales Soar." FiercePharma, 2 February 2018.
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Think (Bio)Print
Great strides are being made in bioprinting, and the end result could revolutionize pharmaceutical development and testing.
In Conversation: Bringing the Outside In
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In Conversation: Bringing the Outside In
"When a factory is needed in the future, what could it look like, and how should we think and work differently to build it?" This is a question that Roger Connor, President, Global Manufacturing Supply, GlaxoSmithKline, considers frequently. I had the privilege of meeting him during the ISPE 2017 Annual Meeting & Expo. This is an abridged and edited version of our...
Crossing Over to Large Molecules
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Crossing Over to Large Molecules
Improvements in genetic engineering techniques have fueled the growth of well-characterized large molecules since the 1980s. Today, revenues from the sale of biopharmaceuticals in the United States exceed $100 billion annually. 1
  • 1Ernst & Young Global Limited (EY). "Key Dealmaking Insights," in Biotechnology Report 2016: Beyond Borders.
Breakthrough for Pharma Industry & Patients
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Breakthrough for Pharma Industry & Patients - FDA Approved Gene Transfer Therapy
On 30 August, the US Food and Drug Administration (FDA) approved Novartis's Kymriah (tisagenlecleucel, CTL019), the first gene therapy for the treatment of pediatric and young-adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia (ALL). Kymriah belongs to a class of drugs called chimeric antigen receptor (CAR) T-cell therapies, which constitute a form of immunotherapy...
Patent Battles in the Age of Crispr
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Patent Battles in the Age of Crispr
The CRISPR/Cas9 system (CRISPR) developed for gene editing only a few short years ago* has already revolutionized genomic engineering, and clinical trials for targeted cancer therapies have recently commenced in China and the United States. CRISPR's power lies in its relative simplicity and precision, and it is expected to have profound implications for agriculture and the treatment...
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The Growing Influence of PIC/S in Asia Pacific
The Asia Pacific region, which comprises 24 culturally diverse countries, contains 60% of the world's population and is the fastest growing region in the world today This article describes the growing influence of Pharmaceutical Inspection Co-operation Scheme (PIC/S) in the Asia Pacific region. Of the 24 countries in the Asia Pacific region, 19 are being influenced in some way by...
What Does 2017 Hold in Store for Pharma
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What Does 2017 Hold in Store for Pharma?
What will be the most important industry drivers, its innovations, if any? What indeed! During the ISPE 2016 Annual Meeting Pharmaceutical Engineering caught up with a few industry leaders and asked for their perspectives. Here's what they had to say.