The pharmaceutical industry stands at the precipice of a revolution as emerging digital technologies provide new opportunities to boost productivity through continuous process improvements. The Pharma 4.0™ framework, an adaptation of the broader Industry 4.0 movement, aims to transform how drugs are produced and delivered.
With the approval of the first gene edited therapeutic in 2023, production of gene edited therapies is accelerating, introducing tough decisions for manufacturing development. Gene editing therapy production is complex, often involving multi-modality manufacturing operations in one facility to produce a single therapeutic. This article considers whether retrofitting an aging monoclonal...
Implementing advanced automation technologies is a strategic move that can amplify the positive outcomes of environmental, social, and governance (ESG) initiatives. By leveraging ESG initiatives, pharmaceutical companies can enhance their competitive edge and contribute positively to global sustainability efforts.
Welds used in biopharmaceutical manufacturing must meet critical criteria to maintain a defined level of purity and bioburden control. One highly debated area of concern is the level of discoloration allowable on the product contact surfaces in the welded condition and secondary finishing methods. This article addresses the studies commissioned by the American Society for Mechanical Engineers...
On 25 August 2023, the long-awaited revision to Annex 1 became effective, introducing significant regulatory changes, including the requirement of a documented contamination control strategy (CCS). During a workshop at the 2023 ISPE Annual Meeting & Expo, 11 teams of attendees were presented with a risk-based methodology to develop and evaluate CCS elements focused on extrinsic...
Artificial intelligence (AI) is used by pharmaceutical and biotech companies, providing support from drug discovery through manufacturing. The nature of AI and concerns of bias, privacy, transparency, and security in a regulated industry necessitate a governance framework to ensure concerns are controlled using “guardrails.” These guardrails ensure the quality, privacy, and security of data...
The expectations for room differential pressures to maintain air quality in pharmaceutical facility design are consistent and well defined from a regulatory perspective. However, there is no common approach to the design, monitoring, or alarming of area differential pressures. This article explores differential pressure concerns in aseptic manufacturing, or cleanroom classes B, C, and D.
Growing up on a farm, Allen Koester thought he would design farm equipment after earning his degree in mechanical engineering.
Rod Freeman started his career in the pharma-ceutical industry as an analytical chemist.
Cell and gene therapy (C>) products represent a significant step forward in patient treatment and often offer unique patient benefits. However, product developers face significant hurdles within the regulatory landscape. The tools laid out in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q12 guideline: “Technical and...
The US Food and Drug Administration (FDA) advocates for the integration of quality by design (QbD) principles throughout the pharmaceutical product development landscape, aiming to elevate both process understanding and product quality. Key challenges to the process control strategy include navigating time- and resource-intensive processes. One solution is digital shadow technology which, when...
In the dynamic and highly regulated world of biopharmaceutical manufacturing, maintaining and ensuring quality is a critical success factor. An effective quality risk management (QRM) system is a key component in the overall quality management infrastructure of biopharmaceutical organizations. It offers a structured, scientific, and risk-based approach to decision-making, addressing potential...
Advanced therapy medicinal products (ATMPs) and cell and gene therapies (C>s) represent a promising medical product class that employs gene therapy, cell therapy, or tissue engineering to address various diseases and injuries. One critical aspect of ATMP and C> manufacturing is using cell culture media. With thousands of ATMPs and C>s in clinical trial phases, the role of...
Antibody engineering has transformed the development of therapeutic antibodies, enabling the creation of specific and effective treatments for a range of diseases. These antibody-based therapeutics are advancing in clinical development at a rapid rate and are being approved in record numbers. Currently, more than 100 monoclonal antibodies (mAbs) have been approved for the treatment of various...
Although traditional tank farm systems have long been the cornerstone of buffer preparation, they face challenges that have grown with the expansion of processing scale in the industry.
With the Chinese government initiating drug regulatory reform in 2015 and China joining the International Council for Harmonisation (ICH) in 2017, a significant number of measures have been implemented by the government. The aim is to make fundamental changes to China’s drug regulatory administration system so it can facilitate pharmaceutical development and better meet patient needs in the...
Digital display labels (DDLs) offer an alternative solution to eliminate manual relabeling in the clinical supply chain, optimizing label content updates through a simple, system-controlled approach while providing new, uncharted opportunities. With increased efficiency in making regulatory-compliant changes and enhanced flexibility in the clinical supply chain, DDL technology has the...
Due to the growing digitalization of the industry, we are highly dependent on information technology (IT) systems and data. The basic ability to execute our pharmaceutical business and decision-making processes relies on the permanent availability of these IT systems and data to ensure compliance and efficiency of our business operations. But numerous factors—including criminal activities,...
IT infrastructure has traditionally been provisioned using a combination of scripts and manual processes. This manual approach was slow and introduced the risk of human error, resulting in inconsistency between environments or even leaving the infrastructure in an unqualified state. In this article, we investigate some fundamental advantages of using Infrastructure as Code (IaC) for...
This article provides a brief introduction into the standards and regulations for medical devices. It compares the ISPE GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) and applicable ISPE GAMP Good Practice Guides against the relevant regulations and standards for the development of software for medical devices and demonstrates GAMP® 5 Second...
Advanced therapy medicinal products (ATMPs) are one of the most promising developments in the pharmaceutical and biotech industries in recent decades. Although there is a great promise to treat and even cure many diseases with these products, there are also unique challenges, especially with their supply chains.
Facility design decisions made early in conceptual design can have a significant impact on the cost of goods sold (COGS) in the manufacture of autologous and allogeneic cell therapy products. Understanding the impact of a COGS analysis is an important aspect of the early-phase design process.
Live biotherapeutic products (LBPs) have the potential to treat a wide range of ailments. However, these living microorganisms are difficult to produce due to evolving government regulations and limited GMP manufacturing experience. New facility designs and more specific process guidance could help overcome these challenges. This article explores the nuances of facility design and regulatory...
Cell and gene therapy (C>) products comprise a rapidly growing field of innovative medicines that hold the promise to treat and, in some cases, cure diseases that are otherwise untreatable. In this article, we provide points to consider when evaluating the comparability of C> when changes are made in their manufacturing processes.
As the demand for accelerated access to medicines expands globally, the pharmaceutical industry is increasingly submitting regulatory applications in multiple countries simultaneously. As a result, Boards of Health (BoHs) are challenged with approving these applications in an accelerated timeframe and accommodating the submission of postapproval chemistry, manufacturing, and controls (CMC)...
Faced with global competition and shrinking margins, (bio)pharmaceutical manufacturers worldwide are urged to increase production efficiency by making better use of time and resources. This is in addition to addressing the unique challenges faced by pharmaceutical manufacturers such as a strictly regulated environment, heterogeneous equipment suppliers, and long adaptation times....
This Concept Paper proves that a standard model within OPC UA Alarms and Conditions (OPC UA Part 9) can be leveraged to realize Plug & Produce for exchanging pharmaceutical alarms and audit trails between OT manufacturing equipment and Orchestration Platforms or IT Services like EBR or Historian.
This Concept Paper proves a laboratory device integration utilizing the Asset Administration Shell (AAS) metamodel (agnostic to the underlying technology and data structure).
The pharmaceutical industry stands at the cusp of a transformative era, where the integration of sustainability within the supply chain is not just a trend, but a necessity. The 2024 ISPE Annual Meeting &...
Although parenteral products make up only 1% of global pharmaceutical prescriptions by volume, at list price they now make up nearly half of global sales value, a percentage that has been increasing. Many of these are complex products produced in smaller batches for immunology or oncology, and a large majority are biologic therapies, which are generally poorly suited to oral formulations.
In 2020, CSL initiated a benchmarking activity with a small group of peer companies identified through ISPE to explore creation and maturation of asset management programs at each company. The initial sessions were a success, covering topics such as asset condition evaluations and asset management governance. CSL was keen to continue the conversations and gather more insights on certain...
Pfizer Asia Pacific Manufacturing Ltd has been honored with the 2024 ISPE Facility of the Year Award (FOYA) Category Award Operations in Project Execution. This prestigious award recognizes the outstanding efforts behind the Pfizer API Facility Extension, commonly referred to as Tuas 2, located in Tuas, Singapore.
Each year, ISPE recognizes innovation in pharmaceutical facilities with the Facility of the Year Awards (FOYA). The 2024 FOYA submission finalists were announced at the 2024 ISPE Aseptic Conference in Vienna, Austria. Finalists for the 2024 awards highlight the continued progress and innovation at play in pharmaceutical manufacturing worldwide and across modalities. From projects tailored to...
The ISPE International Company of the Year award recognizes outstanding leadership and support provided by a company, as reflected by significant active participation in the Society’s committees, Communities of Practice (CoPs), programs, and activities, as well as its support of employee participation in ISPE. The winner for 2023, Roche, was announced at the 2023 ISPE Annual Meeting & Expo...
Every year we celebrate the achievements of state-of-the-art pharmaceutical facility projects through the Facility of the Year Awards (FOYA). The buildings are beautiful, energy efficient, and sustainable; the...
In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Matt Lehmann, Custom Training Manager, Professional Development.
Long gone are the days of early morning Women in Pharma breakfast meetings at ISPE international conferences—well, sort of. The long-awaited 2024 ISPE Annual Meeting & Expo is on the horizon and it’s time...
This year, the ISPE Foundation made great strides in its mission of fueling global health equity by fostering access to knowledge and nurturing diverse talent.
In 2019, ISPE released the Second Edition of the ISPE Baseline® Guide Vol 5: Commissioning and Qualification. This guide mirrors the industry’s evolution toward harmonizing with latest...
The new ISPE Good Practice Guide: Unique Identification of Glass Primary Containers in Pharmaceutical Fill and Finish Operations involved a cross-functional team of industry experts and professionals from parenteral/injectable medicine manufacturing. The team included industry competitors who worked together to establish a common approach. They provided a balanced, industrywide perspective on...
In April 2024, ISPE published the ISPE Guide: 503A Compounding - Regulatory Basis and Industry Good Practices for Pharmacies, adding to the growing body of knowledge ISPE is producing for the pharmaceutical compounding industry. Written by industry experts and reviewed by practitioners in the area, the guide provides an overview of relevant US Food and Drug Administration (FDA) regulations and...
As with all aspects of our life sciences industry, understanding how we can best meet the needs of patients with the timely delivery of life saving and sustaining products is of paramount concern. During the years since the global pandemic, the expectations and pressures on the pharmaceutical industry with respect to development, speed to market, quality and sustainability have increased...
At the 2024 ISPE Europe Annual Conference, held in Lisbon, Portugal, 16-18 April, Richard L. Friedman, MS, Deputy Director of the US Food and Drug Administration’s (US FDA) Office of Manufacturing Quality, in...
Insight from Austria’s Regulatory Authority Representative
At the 2024 ISPE Aseptic Conference, held March 12-13 in Vienna, Austria, Christina Meissner, a European Union Good Manufacturing Practice (GMP) inspector at the Austrian Agency for Health and Food Safety since 2013, and Chair of the PIC/S Drafting Group on Annex 2A and 2B, published in May 2021, offered a presentation titled...
The ISPE community is saddened by the passing of James (Jim) O'Brien, a founding member of ISPE and a luminary in the field of pharmaceutical engineering. Jim was a recognized expert in the design and engineering of pharmaceutical facilities, whose profound influence has shaped our industry.
Having a universal and uniform Common Technical Document (CTD) for all markets, major and emerging, is an aspiration of all pharmaceutical companies. As markets become more familiar with the CTD, especially the quality portion, some drug regulatory agencies are requesting more regional/local documents and customization to CTD documents in accordance with their local interpretation and...
During the COVID-19 pandemic, vaccines were one of the drug products recommended by the World Health Organization (WHO) to fight the pandemic. The majority of regulators have flexed their local regulatory requirements to bring vaccines to the market with as much supply flexibility as possible, including emerging markets which typically have challenging local requirements that a marketing...
This blog summarizes a presentation by Rick Friedman, Deputy Director of the US FDA Office of Manufacturing Quality, on 17 April 2024 at the 2024 ISPE Europe Annual Conference in Lisbon, Portugal. The...
One of the keynote sessions of the 2024 ISPE Europe Annual Conference held 16-18 April in Lisbon, Portugal was a presentation on EU initiatives to advance digitalization in manufacturing by Evdokia...
ISPE connected with Sydney Hamilton, Strategic Facility Planner, CRB, and Scott McNallan, Director of Architectural Design, CRB, for a sneak peek look at their planned session, “Blank Slate to Building Excellence,” ahead of the 2024 ISPE Biotechnology Conference. The conference will take place 17-18 June 2024 in Boston, Massachusetts, USA.
It becomes clear that a topic has become mainstream when it crosses multiple Communities of Practice and areas of interest. In preparation for the 2024 ISPE Annual Meeting & Expo, the Digital Transformation track committee worked closely with multiple teams from other tracks on the topic of artificial intelligence/machine learning (AI/ML) to identify the best...
Green chemistry is a field of chemistry that focuses on developing and utilizing more sustainable and environmentally friendly chemical processes and products. Green chemistry is a growing field in pharmaceutical laboratories that aims to reduce the environmental impact of drug discovery, development, and manufacturing processes. It involves the application of sustainable and innovative...
Time has a remarkable ability to slip through our fingers, doesn't it? With June's arrival, we're reminded of how swiftly the year passes. As we transition into the third quarter, it's a pivotal moment for us to reassess our goals and lay the groundwork for the months ahead, even looking ahead to the following year. View the full blog for recent membership announcements, etc.
Whether networking at events or collaborating through our Communities of Practice, the value of an ISPE membership is in the connections made between pharmaceutical industry professionals and Regulators to collaborate on solutions to common goals and challenges.
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