Front-End Design of Personalized Medicine Facilities
Front-End Design of Personalized Medicine Facilities
Features
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The commercialization of personalized medicine has ushered in demand for a new type of facility—personalized medicine facilities—which can produce thousands of small-scale batches per year. There are currently only a handful of these sites, but many more are in various stages of design and construction. Designing these personalized medicine facilities presents new challenges, and a different design approach is necessary. Cyclic scheduling can produce high-quality models rapidly and aid collaborative design. A focus on room and zone availability and movements can prevent bottlenecks in corridors, gowning, and airlocks to streamline production.

Featured Articles

Post-approval Change Management for Cell and Gene Therapy Products
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Post-Approval Change Management for Cell and Gene Therapy Products

Cell and gene therapy (C&GT) 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...

In-Silico Data-Driven Mechanistic Model–Assisted Process Validation
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In-Silico Data-Driven Mechanistic Model–Assisted Process Validation

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...

Quality Risk Management for Biopharmaceuticals
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Quality Risk Management for Biopharmaceuticals

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...

Cell Culture Media Manufacturing Controls for Bio-Manufacturing
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Cell Culture Media Manufacturing Controls for Bio-Manufacturing

Advanced therapy medicinal products (ATMPs) and cell and gene therapies (C&GTs) 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&GT manufacturing is using cell culture media. With thousands of ATMPs and C&GTs in clinical trial phases, the role of...

Building Better Therapies With Antibody Engineering
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Building Better Therapies With Antibody Engineering

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...

CoP Leader Profiles: Laura-Ann Chin, PE (Biotechnology Community of Practice Co-chair)
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Volunteer Leader Profile: Biotechnology CoP Co-Chair Laura-Ann Chin, PE

Laura-Ann Chin has more than 12 years of international and domestic contract and hands-on process engineering experience in the design and construction of current GMP facilities in the US, Europe, and Asia. She specializes in single-use solutions and modular technologies for scale-up, scale-out, and technology transfer in maximizing the performance of advanced therapy medicinal products,...

CoP Leader Profiles: Glenn Lawrence, PE , CPIP (Containment Community of Practice Chair)
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Volunteer Leader Profile: Containment CoP Chair Glenn Lawrence, PE

Glenn Lawrence’s first position at Merck & Co. was as a shift engineer for a large factory in Rahway, New Jersey. It was a great learning ground for chemical processing and automation. Glenn was in operations when he was asked to join the engineering department, where he did plant design for active pharmaceutical ingredients and vaccines. He was then asked to take over the engineering...

Evolving China’s Regulatory System in Alignment with ICH
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Evolving China’s Regulatory System in Alignment with ICH

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 Labeling in Clinical Supplies for Clinical Trials
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Digital Display Labeling in Clinical Supplies for Clinical Trials

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...

Quality Considerations in Disaster Recovery: A Case Study
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Quality Considerations in Disaster Recovery: A Case Study

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,...

The Use of Infrastructure as Code in Regulated Companies
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The Use of Infrastructure as Code in Regulated Companies

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...

Leveraging GAMP® 5 Second Edition for Medical Devices
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Leveraging GAMP® 5 Second Edition for Medical Devices

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...

Delivering Curative Therapies: Autologous vs. Allogeneic Supply Chains
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Delivering Curative Therapies: Autologous vs. Allogeneic Supply Chains

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.

Optimizing Cost of Goods for Cell Therapy Manufacturing
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Optimizing Cost of Goods for Cell Therapy Manufacturing

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: Moving the Microbiome to the Patient
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Live Biotherapeutic Products: Moving the Microbiome to the Patient

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...

Comparability Considerations for Cellular & Gene Therapy Products
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Comparability Considerations for Cellular & Gene Therapy Products

Cell and gene therapy (C&GT) 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&GT when changes are made in their manufacturing processes.

An Evaluation of Postapproval CMC Change Timelines
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An Evaluation of Postapproval CMC Change Timelines

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)...

Air Speed Qualification: At Working Position or Working Level?
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Air Speed Qualification: At Working Position or Working Level?

The new European Commission GMP Annex 1 “Manufacture of Sterile Medicinal Products” and the equivalent Annex 2 from the World Health Organization (WHO) triggered a discussion in ISPE’s Germany/Austria/Switzerland (D/A/CH) Aseptic Processing Community of Practice (CoP) Steering Committee about where to qualify air speed: “at working position” versus “at working level.” This article provides...

Considerations for a Decentralized Manufacturing Paradigm
Features
Considerations for a Decentralized Manufacturing Paradigm

The biopharmaceutical industry must develop and implement innovative ways of working to be effective and efficient in the current healthcare ecosystem, in which high-quality medicines, adaptability, and assurance of supply are of critical importance. There are regulatory strategies and technologies emerging to address these challenges, but further progress must be made to fully harness the...

New EU AI Regulation and Gamp® 5
Features
New EU AI Regulation and GAMP® 5

This article describes how ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) and related GAMP Good Practice Guides can be effectively applied to help meet the requirements of the proposed European Union (EU) artificial intelligence (AI) regulation for qualifying GxP-regulated systems employing AI and machine learning (ML).

Enabling Global Pharma Innovation: Delivering for Patients
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Enabling Global Pharma Innovation: Delivering for Patients

ISPE has launched an important new initiative, “Enabling Global Pharma Innovation: Delivering for Patients,” in support of the aspirations of many regulatory agencies globally to promote introduction of innovative pharmaceutical manufacturing.

ICH Q13 and What Is Next for Continuous Manufacturing
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ICH Q13 and What Is Next for Continuous Manufacturing

The creation of a new ICH guidance document, Q13,1

  • 1International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “ICH Harmonised Tripartite Guideline Q13: Continuous Manufacturing of Drug Substances and Drug Products.” Published July 2021.
A Systemwide Approach to Managing the Risks of Continuous Manufacturing
Features
A Systemwide Approach to Managing the Risks of Continuous Manufacturing

Understanding and managing risks to continuous manufacturing (CM) technology is central to any decision to greenlight CM in a production-ready environment. Applying a systemwide risk management (SRM) approach to manufacturing is essential to ensuring manufacturing projects are vetted in a comprehensive and consistent manner.

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Latest Articles

Peyton Myers
iSpeak Blog
Emerging Leader Hacker to GAMPer in 10 Weeks

The following blog post was provided by Peyton Myers, an undergraduate student at Appalachian State University. Myers attended the 2023 ISPE Annual Meeting & Expo in Las Vegas as an ISPE Foundation Professional Development Grant recipient.

Meet the ISPE Staff: Matt Lehmann
InTouch
Meet the ISPE Staff: Matt Lehmann

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.

Pharma 4.0™ Plug and Produce Working Group Publishes Concept Papers
InTouch
Pharma 4.0™ Plug and Produce Working Group Publishes Concept Papers

One of the primary technical objectives of the ISPE Pharma 4.0™ Plug and Produce Working Group is to assist the Pharma 4.0™ digital transformation by enabling seamless integration and interoperability between all systems components and operational technology to advance the overall digital maturity toward predictive and adaptable operations.

New Guides Expand ATMP Knowledge
InTouch
New Guides Expand ATMP Knowledge

The ISPE Guide: Advanced Therapy Medicinal Products – Allogeneic Cell Therapy and the ISPE Guide: Advanced Therapy Medicinal Products – Recombinant AAV Comparability and Lifecyle Management were published earlier this year. These guides add to ISPE’s library of knowledge in the growing and ever-evolving advanced therapy medicinal products (ATMPs) field.

Frances Zipp Receives 2023 Professional Achievement Award
InTouch
Frances Zipp Receives 2023 Professional Achievement Award

Frances (Fran) M. Zipp was awarded the ISPE Joseph X. Phillips Professional Achievement Award at the 2023 ISPE Annual Meeting and Expo. The award is named in honor of Joe Phillips, longtime supporter of ISPE and a leader in establishing the Society as an “integrator” of industry and regulators, both during his years of service with the FDA and later when he became International Regulatory...

Vivien Santillan
Insights
Women in Pharma® Editorial: An Era of Innovation and Emerging Technologies

The emergence of new modalities and innovations on drug development and research, such as advanced therapy medicinal products (ATMPs) and personalized and precise therapies, presents new opportunities for the treatment and management of diseases and injuries. As these innovations continue to evolve, the regulatory landscape likewise evolves and this has led to the production of higher-quality,...

Scott W. Billman
Insights
Message From the Chair: ATMPs and Biotech in 2024

It is hard to believe that we are halfway through the year for the ISPE programs and the Board of Directors in 2024. We have continued to progress through the 2023–2025 ISPE Strategic Plan with engagement from Chapters, Affiliates, the ISPE Foundation, and ISPE committees and volunteers.

Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization
iSpeak Blog
Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization

The integration of data science in biopharmaceutical manufacturing, emphasizing data quality, tech transfer efficiency, and process optimization, is the heart of this track. Led by industry experts, discussions explore leveraging digital twins, predictive analytics, and continuous improvement initiatives. Additionally, interactive roundtable discussions provide attendees with a dynamic forum...

AM23 Hackathon participants
iSpeak Blog
Entering a New Era of Innovation and Collaboration With the Focus on the Workforce of the Future

The pharmaceutical sector stands at a crossroads of immense possibilities. We are witnessing an unprecedented surge in innovation, fueled by a remarkable partnership between industry and regulatory authorities. For example, there are initiatives fostered by the US Food and Drug Administration (US FDA) to promote innovation with programs such as CATT (CBER Advanced Technologies Team) and ETP...

ISPE Foundation Professional Development Grant Recipient Silas Tamufor
iSpeak Blog
Q&A with ISPE Foundation Professional Development Grant Recipient Silas Tamufor

Through the ISPE Foundation Professional Development Grant program, Silas Tamufor attended the 2023 ISPE Annual Meeting & Expo in October 2023. Tamufor is a PhD student and ISPE Boston Chapter member who began serving as the ISPE Boston Educational Programs Committee Chair in December 2023. He, along with 87 other students and recent graduates, attended the conference thanks to the...

Quality Management Maturity
iSpeak Blog
Quality Management Maturity: The Strategic Vision for Biopharmaceutical Excellence

To meet the biopharmaceutical industry’s duty to manufacture safe and effective therapies for patients, a robust quality system is fundamental to success. A quality system should link to quality culture and prioritize focusing on quality, led by management, that fosters sustainable compliance and consistent production of high-quality drugs. Strong quality culture attributes include a proactive...

Roundtable Discussion – Lean Stability
iSpeak Blog
Lean Stability Strategies and Best Practices Discussed during Webinar

Stability sampling and testing are key to ensuring that products maintain safety, identity, strength, purity, and quality throughout their claimed shelf life. It is also a regulatory requirement per ICH Q5. However, storing product samples in different environmental conditions, testing those samples for three to five years (or more) after initial manufacture, and properly analyzing and...

Industry 4.0 Machinery Production Facility
iSpeak Blog
Challenges and Trends in Biopharmaceutical Facility Design

Biopharmaceutical facility design is a critical aspect of the industry. Overall cost pressures in the global health system, regional requirements to deploy manufacturing rather than centralize manufacturing in one location, technology enhancements in cell biology and format, flexibility to accommodate multi-product campaigns with different production schedules, and speed-to-market are among...

DNA strands-by Thomas
iSpeak Blog
Message From the Chair: Why Attend the 2024 ISPE Biotechnology Conference | Biopharmaceutical Engineering

The biotechnology industry continues to evolve, advancing the frontiers of science and engineering in the design, development, and manufacture of a wide variety of therapeutic modalities. Advances in cell and gene therapies continue to offer treatments for diseases that were previously uncurable, with seven approvals in 2023, including treatments for sickle-cell disease, hemophilia, type 1...

EU23_ISPE_Executive Forum
iSpeak Blog
ISPE Women in Pharma® Panel Overview: 2024 ISPE Europe Annual Conference

The International Society of Pharmaceutical Engineering’s (ISPE) Women in Pharma® group was established in 2017. Since its inception, it has grown to a community of more than 2,000 members who are actively engaged in educational, collaborative, and networking activities designed to bridge gender, cultural, organizational, and geographic boundaries, maximize the impact women have in...

2023 ISPE Annual Meeting & Expo Women in Pharma® event
iSpeak Blog
The Changing Landscape: Celebrating Women's Rise in Pharma in the University Setting

Since starting with ISPE, Edyna Miguez, has had the incredible opportunity to connect with women across the globe working within the pharmaceutical industry, as part of the ISPE Women in Pharma® program. The tenure of these rising female leaders varies, as do their cultural backgrounds. However, one fact remains consistent: they are looking to make the industry a more equitable and...

The Machine Learning Life Cycle (MLLC): Key Artifacts, Considerations, and Questions
iSpeak Blog
The Machine Learning Life Cycle (MLLC): Key Artifacts, Considerations, and Questions

It is an exciting time in life sciences. Many companies have focused initial artificial intelligence/machine learning (AI/ML) adoption efforts on developing and implementing ML trained algorithms, which necessitate following a controlled approach such as the GAMP® 5 ML Sub-System methodology shown below. This blog highlights key artifacts and considerations when implementing AI/ML for GxP use...

Concluding Compliance Challenges with Validation 4.0
Technical
Concluding Compliance Challenges with Validation 4.0

As the pharma industry moves to an ambitious Validation 4.0 paradigm, computerized systems play a pivotal role in enabling the rapid transition. Innovation and agility in computerized system validation (CSV) received a strong push in the second half of 2022 with the publication of the FDA draft guidance on “Computer Software Assurance for Production and Quality System Software”

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What Should You Consider When Scaling Fill/Finish for Cell and Gene Therapy?

Transitioning from lab manufacture to commercialization presents significant challenges, no matter what area you’re working in. Cell and gene therapies are no different and production quantities must scale at multiple stages, first to support clinical trials and then when they reach the market. With uniquely challenging conditions required to protect medicinal integrity and exceptionally high...

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Navigating the Complexities of Environmental Monitoring in Pharmaceutical Cleanrooms

Environmental monitoring (EM) in pharmaceutical manufacturing is a critical component of ensuring product safety and efficacy. This article aims to unravel the considerations for optimal sample collection and data evaluation within pharmaceutical environmental monitoring programs, presenting this technical domain in an accessible and insightful manner.

Current Issue

Pharmaceutical Engineering

May / June 2024

Front-End Design of Personalized Medicine Facilities Cover: The commercialization of personalized medicine has ushered in demand for a new type of facility— personalized medicine facilities—which can produce thousands of small-scale batches per year. There are currently only a handful of these sites, but many more are in various stages of design and construction. Designing these personalized...