Advanced Therapy Medicinal Products
Advanced Therapy Medicinal Products
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The ATMP Issue: In this issue, we focus on the manufacturing of advanced therapy medicinal products, the costs associated with patient access, and readiness.

Featured Articles

Streamlining the Vein-to-Vein Process: The Future of Automated Cell Therapy Manufacturing
Features
Streamlining the Vein-to-Vein Process: The Future of Automated Cell Therapy Manufacturing

Cell therapies, especially autologous chimeric antigen receptor T cell (CAR T cell) treatments, are transforming personalized medicine, bringing new hope to patients with conditions once thought untreatable. However, the manufacturing processes for these therapies remain predominantly manual, presenting significant challenges in scalability, consistency, and making these treatments more widely...

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Features
Final Preparation of ATMPs at Point of Care

Advanced therapy medicinal products (ATMPs), which include cell and gene therapy (C&GT) products, frequently require handling steps between quality control release and patient administration. These steps take place directly at the point of care and are especially critical for C&GTs with limited shelf life after preparation.

Unlocking ATMPs: Reducing Cost as an Obstacle to Patient Access
Features
Unlocking ATMPs: Reducing Cost as an Obstacle to Patient Access

Advanced therapy medicinal products (ATMPs) have the potential to treat life-threatening, incurable conditions. But access to these therapies remains challenging due to the nature of current ATMP manufacturing models. This article explores solutions, focusing on standardized processing and shared knowledge as gateways to automated, robotic manufacturing and decentralized production.

Resilience for Cell Therapy Manufacturers: Five Strategies
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Resilience for Cell Therapy Manufacturers: Five Strategies

For patients who depend on personalized medicine, turnaround time matters. However, moving quickly is difficult for cell therapy companies because designing personalized therapies presents unique challenges unknown in traditional biotechnology. In this article, we’ll examine five strategies to help cell therapy companies develop resilience against these challenges, positioning themselves to...

Applicability of Vaporized Hydrogen Peroxide for Contamination Control of Lyophilized Biohazards
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Applicability of Vaporized Hydrogen Peroxide for Contamination Control of Lyophilized Biohazards

Controlling contamination in environments where biological medicinal products are handled is of paramount importance to ensure the safety of personnel, sterility of drug products, and protection of the surrounding environment. The application of vaporized hydrogen peroxide (vH2O2) has emerged as a promising method for postproduction decontamination due to its ability to...

Lessons from a Cost of Goods Analysis Workshop
Features
Lessons from a Cost of Goods Analysis Workshop

Advanced therapy medicinal products (ATMPs) are transformative therapeutics that are realizing increasing gains in market approvals, yet are expensive products to produce. To enable a broader application of these medicinal products in the marketplace, the cost of goods (COGs) sold should be addressed early in development with a focus on reduction of cost to the patient.

Continuous Viral Vector Manufacturing
Features
Continuous Viral Vector Manufacturing

A growing segment of the advanced therapy medicinal product (ATMP) landscape, which includes gene therapies and cell-based treatments, relies heavily on viral vectors for efficient gene delivery. The increasing demand for these therapies requires a robust, scalable, and cost-effective manufacturing solution.

ISPE Advocates for Members with European Medicines Agency
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ISPE Advocates for Members with European Medicines Agency

ISPE is an officially recognized stakeholder of the European Medicines Agency (EMA), the agency responsible for the monitoring of medicines in the European Union. One of the ways ISPE helps its members stay at the forefront of industry challenges and changes is by interacting with regulatory authorities in the countries our members represent.

Volunteer Profile: Massimiliano Cesarini, Sterile Products Processing Community of Practice Chair
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Volunteer Profile: Massimiliano Cesarini, Sterile Products Processing Community of Practice Chair

Massimiliano Cesarini, MEng, was named CEO of Biogenera SpA, Bologna, Italy in 2024. He began his career at Duferco Engineering in energy generation, then moved to Comecer Group, holding roles as project and product manager, and global sales manager for the pharma and advanced therapy medicinal product (ATMP) division. He eventually joined Omnia Technologies Group establishing the Omnia Life...

Volunteer Profile: Krisha Patel, ATMP Community of Practice Co-Chair
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Volunteer Profile: Krisha Patel, ATMP Community of Practice Co-Chair

Krisha Patel is Co-Founder of Assurea LLC, a digital compliance consulting firm that provides IT and validation services, software assurance, and custom artificial intelligence solutions for biotech companies. With a degree in bioprocessing science and more than 12 years of experience in computer system validation and quality assurance, Patel has worked with cell and gene therapy companies,...

Embracing the Human Side of Manufacturing
Features
Embracing the Human Side of Manufacturing

For companies focused on producing lifesaving treatments, the positive effects of employee health, well-being, and satisfaction can be easily overlooked, but those positive effects are real. An investment in people results in better research, testing, and manufacturing processes, which leads to more efficient delivery of therapies and treatment to patients worldwide.

Nurturing a Culture of Collaboration and Growth
Features
Nurturing a Culture of Collaboration and Growth

Organizations must continually evolve and adapt in order to grow, sustain, and stay competitive. No organization survives for a long period of time if it does not change with the times. The pace of change is accelerating, and the scale of disruptive market forces is growing by the day.

Indian Pharmaceutical Industry: Creating Global Impact
Features
Indian Pharmaceutical Industry: Creating Global Impact
India’s pharmaceutical sector is not only a cornerstone of its national economy, but it’s also a pivotal player on a global stage. As of 2023, India ranked as the third-largest producer of drugs and pharmaceuticals by volume, with a 20% global share in the export of generic drugs. Currently valued at US$50 billion, the country has an ambitious goal for the sector: to grow its value to US$450...
A GAMP® Approach to Computerized System Life Cycle and IT Process Records
Features
A GAMP® Approach to Computerized System Life Cycle and IT Process Records

This article describes a practical and pragmatic approach to the management of computerized system life cycle and information technology (IT) process records. The objective is to effectively achieve and maintain compliant GxP-regulated systems that are fit for intended use, and to support patient safety, product quality, and data integrity.

Removing the Frustration from Functional Risk Management
Features
Removing the Frustration from Functional Risk Management

Risk assessment is essential, however, risk assessment is of limited value if it is not conducted by a team with the necessary process, product, and functional understanding. Conducting risk assessments prematurely may lead to invalid assessment of overall risks. Conducting risk assessments too late will limit the opportunity to address design flaws and effectively test processes and...

Celebrating 25 Years of GAMP® Americas
Features
Celebrating 25 Years of GAMP® Americas

This special anniversary article addresses the history and milestones that define the GAMP Community of Practice (CoP). In celebration of the 25th anniversary of the creation of GAMP Americas, we reflect on the vital role GAMP Americas has played in that journey. We commemorate key accomplishments of its members, share recent activities, and look ahead to the future of GAMP Americas.

3R Initiative Within Roche’s Global QC Network
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3R Initiative Within Roche’s Global QC Network

This article describes the numerous activities in the commercial quality control (QC) network that aim to replace in vivo assays with alternative methods in the course of production and release.1

Decarbonizing Pharmaceutical Manufacturing Facilities
Features
Decarbonizing Pharmaceutical Manufacturing Facilities

Reducing the pharmaceutical industry’s carbon footprint has become a management responsibility. This article introduces some of the key points, actual methods, and practical examples of our implementation to reduce carbon emissions from pharmaceutical manufacturing facilities in Southeast Asia.

Industry Perspectives on Practical Application of Platform Analytical Procedures
Features
Industry Perspectives on Practical Application of Platform Analytical Procedures

Pharmaceutical and biotechnology companies employ platform analytical procedures in the development stages of their synthetic and biological drug products and are beginning to leverage them for commercial products. This shift is supported by the acceptance of platform procedures in the recently adopted ICH Q2(R2) and ICH Q14. Six case studies are shared in this article to highlight how...

Global Collaborative Review: Understanding Overall Control Strategy and Patient Benefit-Risk
Features
Global Collaborative Review: Understanding Overall Control Strategy and Patient Benefit-Risk

The pharmaceutical industry faces considerable challenges throughout the development, manufacturing, and supply of medicines, largely due to the intricate and divergent global regulatory landscape. The adoption of structured data standards and utilization of cloud-based platforms offer immense potential to overcome these challenges by facilitating faster and more efficient global...

2024 ISPE Aseptic Regulatory Panel Q&A
Online Exclusives
2024 ISPE Aseptic Regulatory Panel Q&A

On 13 March 2024, ISPE concluded the 2024 Aseptic Conference with a regulatory panel question and answer session. Attendees were invited to submit questions to representatives from the Austrian Agency for Health and Food Safety (AGES), US Food and Drug Administration (FDA), Regierungspraesidium Tübingen (RP Tübingen), World Health Organization (WHO), Therapeutic Goods Administration (TGA), and...

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Features
Pharma Facilities, Composable Tools, and Validation 4.0

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.

Gene Editing and Facility Retrofits for CRISPR and Beyond
Features
Gene Editing and Facility Retrofits for CRISPR and Beyond

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...

Explore

Technology and Innovation
White Paper
Digital Validation – Future Advances
The life science validation sector is evolving with a focus on risk-based methodologies and increased access to digital data, driving innovation. The rise of Digital Validation Tools (DVTs) reflects the industry's emphasis on data integrity and principles of Pharma 4.0 and Validation 4.0. These advancements streamline monitoring and provide real-time insights into validated statuses through...
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White Paper
Digital Validation – Use Cases, Challenges, Standards, and Regulatory Guidance

Currently, there is no single guidance document providing a comprehensive roadmap for executing digital validation. While elements from ISPE GAMP® Guides Series and the ISPE Baseline® Guide: Volume 8 – Pharma 4.0™, apply to digital validation, there is no consolidated resource addressing common questions. The authors of this Concept Paper therefore advocate for the development of a Good...

Latest Articles

Navigating the Horizon
iSpeak Blog
Navigating the Horizon: ISPE’s Vision for Tomorrow
For centuries, explorers have scanned the horizon in search of opportunity and clarity. At ISPE, we carry forward that spirit of discovery as we look to the future of pharmaceutical science and manufacturing.
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iSpeak Blog
When Analytics Meet Quality
In today’s data-driven world, the quality management paradigm in the biotech industry has transcended traditional methodologies, embracing advanced analytics and emerging technologies to redefine efficiency, precision, and speed to market. The adoption of machine learning, predictive analytics, and big data has revolutionized quality management, enabling companies to address complex challenges...
A Regulatory Surveillance and Advocacy Framework
iSpeak Blog
A Regulatory Surveillance and Advocacy Framework

At the 2024 ISPE Annual Meeting & Expo, a session titled “Regulatory Surveillance and Advocacy” was presented by Christine Moore, PhD, Executive Director, Quality Systems and Compliance at Organon LLC. Moore spoke about the definition of regulatory surveillance of policy and standards, and going beyond surveillance into regulatory intelligence, specifically related to inspections and...

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iSpeak Blog
Where Are We on the Digital Road Map? Find Out at the 2025 ISPE Biotechnology Conference
Digital transformation isn’t a future concept in the biopharmaceutical industry—it is already impacting manufacturing and quality control processes. Recent advancements and best practices will be showcased at the upcoming 2025 ISPE Biotechnology Conference, where the track “Implementing Digital Initiatives in the Biopharmaceutical Industry: Where Are We on the Road Map?” dives deep into the...
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iSpeak Blog
The Journey to Pharma 4.0™: Are We There Yet?

Pharma 4.0™ represents a transformative shift within the pharmaceutical industry, redefining how medicines are developed, manufactured, and delivered. At its core, Pharma 4.0 involves the integration of advanced digital technologies...

Shaping the Future of Biomanufacturing Facilities
iSpeak Blog
Shaping the Future of Biomanufacturing Facilities

Biomanufacturing is advancing rapidly, and as the industry evolves, so too must the facilities that support it. Therapeutic modalities are becoming more diverse, and with the increasing demand for speed, flexibility, and sustainability in production, biopharmaceutical facilities must be prepared to meet these new challenges.

Antonio R. Moreira
InTouch
The ISPE Foundation Honors Dr. Antonio Moreira’s Legacy

The Dr. Antonio Moreira Memorial Professional Development Fund was established in 2024 in honor of Dr. Moreira, a former Chair of the ISPE Foundation Board of Directors who passed away that same year. As a 20-year member of ISPE, he was a dedicated leader who consistently championed the ISPE Foundation and tirelessly promoted the importance of student development and engagement.

Assessing Containment Equipment and Systems with New ISPE Guide
InTouch
Assessing Containment Equipment and Systems with New ISPE Guide

Effective containment systems in a pharmaceutical manufacturing facility are essential to protect the health of workers, the environment, and patients receiving the medications. Particles released into the facility can cause adverse side effects to facility employees, and particles released outside the facility can harm the atmosphere and nearby waterways.

New Guide Helps Pave the Way to Digital Validation
InTouch
New Guide Helps Pave the Way to Digital Validation

The ISPE Commissioning & Qualification (C&Q) Community of Practice (CoP) conducted a survey in 2023 on the adoption of integrated C&Q, specifically on the use of paperless digital systems for planning, executing, and reporting C&Q activities. The survey revealed that 74% of respondents planned to use Digital Validation Tools (DVTs) for C&Q by 2024.

ISPE Engage Launches Volunteer Portal
InTouch
ISPE Engage Launches Volunteer Portal

ISPE has launched a new feature on ISPE Engage, providing members with a portal to explore volunteer opportunities across the organization.

Lou Schmukler
Insights
Guest Column: Lessons from the Empowerment Battlefield

Empowerment is providing employees with the autonomy, tools, and trust to make decisions that impact their roles and the organization. It requires a shift from the more traditional directive or micromanagement style to fostering a sense of ownership and accountability.

emerging-leaders-Rebecca Roscher
Insights
Emerging Leaders Editorial: Gamification - Re-Igniting Curiosity as Key to Life-Long Learning
In pharmaceutical manufacturing, it is crucial that we commit to lifelong learning and stay informed about the latest advancements in the advanced therapy medicinal products (ATMP) market. Staying up to date on the latest technologies and methodologies allows us to maintain a competitive edge in the industry. However, when learning becomes a “duty,” we risk feeling drained of energy and becoming...
Board-Chair_Jeffrey_Biskup
Insights
Message from the Chair: ISPE Guides and Resources on Biopharma, ATMPs, and C&GT

Biopharmaceuticals continue to proliferate in the pharmaceutical industry leading to advancements in advanced therapy medicinal products (ATMPs), cell and gene therapy (C&GT), and other biological products. ISPE supports its membership base of over 22,000 members across more than 120 countries by informing strategies, supporting solutions, and improving processes in this continually...

Meet the ISPE Staff: Xuandai Hoang
InTouch
Meet the ISPE Staff: Xuandai Hoang

In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Xuandai Hoang, Senior Member Services Coordinator in the Membership Department.

PMH_20-035_STERIS
iSpeak Blog
Validation of an Automated Glassware Washer

The ISPE Sterile Products Processing Community of Practice (CoP) Steering Committee continues its series of blog posts, where committee members and other contributing subject matter experts (SMEs) dive into the validation and use of essential equipment and processes that drive sterile processing in the pharmaceutical industry. The aim is to provide practical insights that will enhance your...

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iSpeak Blog
Trends and Opportunities: How Artificial Intelligence (AI) and Machine Learning (ML) are Reshaping Biotechnology
As biotechnology continues to advance at an extraordinary pace, organizations face a common challenge: how to keep up with increasing complexity while accelerating speed to market. From biosimilars and bio-betters to cell and gene therapies, advanced therapy medicinal products (ATMPs), and mRNA-based treatments, the industry is transforming, and so too must the tools the industry uses to develop...
ISPE Member Spotlight - Nathan Roman
iSpeak Blog
ISPE Member Spotlight: Nathan Roman

Nathan Roman is a Director, Industry Advisor, and Global Brand Ambassador with Ellab. He has been an ISPE Member since 2004. In the question-and-answer interview below, Roman reflects on why he joined ISPE, how ISPE has impacted his career, and more.

Process Intensification, Continuous Manufacturing, and Sustainability
iSpeak Blog
Process Intensification, Continuous Manufacturing, and Sustainability

Biotech companies are meeting modern sustainability objectives and gaining a competitive advantage by implementing process intensification strategies and continuous manufacturing technologies to improve production efficiency while reducing impacts on our environment. Attendees will learn about innovative approaches to process intensification, continuous manufacturing, and sustainability in...

Good Practice Guide: Digital Validation
iSpeak Blog
New ISPE Good Practice Guide Helps Pave the Way to Digital Validation

In 2023, the ISPE Commissioning and Qualification (C&Q) Community of Practice (CoP) conducted a survey on the adoption of integrated C&Q, focusing on the use of paperless/digital systems for planning, executing, and reporting C&Q activities. According to the survey, 74% of respondents anticipated using digital validation tools (DVTs) for C&Q by 2024. “Over the last five years,...

Sponsored content is the sole responsibility of the authors and is not endorsed, reviewed, nor a published article of Pharmaceutical Engineering® magazine or ISPE.

Kneat eBook: AI’s Role in Life Sciences QA & Validation
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Kneat eBook: AI’s Role in Life Sciences QA & Validation

Pharma 5.0™ is here, and AI is transforming the life sciences industry. Are your QA and validation processes ready? Kneat’s eBook, authored by AI expert Daniel Tobin, offers a comprehensive guide to leveraging AI for compliance, efficiency, and innovation at your organization.

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Sponsored Content
Strategic Partnership in Life Sciences

A Technical-Scientific Approach to Business Risk Management. The Life Sciences industry faces increasing complexity due to scientific and technological advancements, regulatory pressures, and evolving market dynamics. Companies must navigate competition, supply chain risks and complexities, digital transformation, and regulatory changes while managing internal challenges such as financial...

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Future Labs. Strategies for designing and building laboratories that adapt, innovate, and thrive.

In the fast-evolving life sciences sector, lab design, functionality, and technology integration are key to efficiency, collaboration, and success. With rising demand, companies are embracing agile, science-first strategies. A major shift is the integration of AI and machine learning, transforming research and pharmaceutical labs. These advancements streamline operations and drive innovation,...

MicronView’s EMC Robot Line: Revolutionizing Cleanroom Monitoring
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MicronView’s EMC Robot Line: Revolutionizing Cleanroom Monitoring

Process automation has become increasingly critical in pharmaceutical manufacturing due to stringent regulatory requirements and limitations inherent to manual environmental monitoring. This article highlights the key challenges associated with manual monitoring, such as contamination risks, human error, labor intensity, and inconsistent compliance, and presents robotic systems as...

Current Issue

Pharmaceutical Engineering

May / June 2025

The ATMP Issue: In this issue, we focus on the manufacturing of advanced therapy medicinal products, the costs associated with patient access, and readiness.