July / August 2023

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Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing

Cover: Continuous manufacturing (CM) challenged regulators’ expectations and regulatory frameworks. This article discusses how US regulators addressed the regulatory hurdles related to CM to broaden its adoption through engagement, regulatory science, guidance, and international harmonization.

ICH Q13 and What Is Next for Continuous Manufacturing

Feature: The creation of a new ICH guidance document, Q13 [1], presents an opportunity for industry and regulators around the world to connect and develop harmonized regulatory expectations for the continuous manufacturing (CM) of drug substances and drug products, resulting in an increased likelihood of implementation across the globe.

Agile, Data-Driven Life Cycle Management for Continuous Manufacturing

Feature: Pharmaceutical continuous manufacturing (CM) is recognized as a key process intensification technology, with investment expected to rise in the coming years and the focus shifting toward biologics. This article provides a review on the current state of CM implementation, offers insights into life cycle management and regulatory aspects, and explains how a data and knowledge-centric approach to risk management can help CM achieve its full potential.

ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma

Technical: ChatGPT and other large language models are positioned to change the world. They can also shift acceptance and prevalence of machine learning solutions in regulated industries in general. However, their arrival requires reconsiderations on risks, quality assurance, and validation from a GxP perspective.

Air Change Rate Reduction during Operation: Success at Roche/Genentech

Technical: To improve the energy efficiency of cleanrooms, the Roche Global Engineering and Oceanside facilities and Engineering team collaborated to implement a risk-based approach to achieve lower air changes during operation without adversely impacting the facility, equipment, or reliability, while meeting environmental requirements.

In This Issue

Features

Continuous manufacturing (CM) challenged regulators’ expectations and regulatory frameworks. This article discusses how US regulators addressed the regulatory hurdles related to CM to broaden its adoption through engagement, regulatory science, guidance, and international harmonization.

Features

In the interest of understanding the current state of continuous manufacturing for biologics and to facilitate the path toward adoption of these promising technologies, the United States Pharmacopeia (USP) and BioPhorum jointly sponsored a hybrid workshop. This article summarizes trends from the workshop and ponders next steps.

InTouch

Heather Watson has been a member of ISPE for 22 years. She is Chair of the GAMP® Global Steering Committee and has been a recipient of the ISPE Committee of the Year Award on three occasions, and was Co-Chair of the ISPE 

InTouch

Christian Wölbeling has been a member of ISPE for 25 years. A founding member and current Chair of ISPE’s Pharma 4.0™ Community of Practice (CoP) Steering Committee, Christian has also been very involved with the GAMP® and Process Analytical Technology CoPs, as well as the ISPE Germany/Austria/Switzerland (D/A/CH) Affiliate.

InTouch

The United Kingdom Emerging Leaders Awards program is an exciting initiative for ISPE because it recognizes and celebrates the efforts and contributions of young engineers in the United Kingdom pharmaceutical engineering and manufacturing sectors.

Technical

ChatGPT and other large language models are positioned to change the world. They can also shift acceptance and prevalence of machine learning solutions in regulated industries in general. However, their arrival requires reconsiderations on risks, quality assurance, and validation from a GxP perspective.

Technical

To improve the energy efficiency of cleanrooms, the Roche Global Engineering and Oceanside facilities and Engineering team collaborated to implement a risk-based approach to achieve lower air changes during operation without adversely impacting the facility, equipment, or reliability, while meeting environmental requirements.

Features

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.
Features

Pharmaceutical continuous manufacturing (CM) is recognized as a key process intensification technology, with investment expected to rise in the coming years and the focus shifting toward biologics. This article provides a review on the current state of CM implementation, offers insights into life cycle management and regulatory aspects, and explains how a data- and knowledge-centric approach...

Features

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.

InTouch

The pharmaceutical industry began applying the principles of continuous processing to the manufacture of oral solid dosage (OSD) forms in the mid-2000s. The consensus among experienced practitioners is that the continuous approach has numerous benefits. “Continuous manufacturing provides for a full range of product life cycle, from small volume clinical production to large volume commercial...

Online Exclusives

The fifth Pharma 4.0™ conference was held December 2022 in Vienna, Austria, in combination with the Aseptic Processing conference. Nearly 500 participants attended either in person or online to learn about the latest developments.

Online Exclusives

The adoption of continuous manufacturing (CM) in the pharmaceutical industry is increasing because of the advantages and opportunities it offers, including the ability to handle hazardous reactions, a higher degree of process integration, and improved sustainability. This article discusses the considerations and approaches adopted by Pfizer, Eli Lilly, GSK, and Amgen in designing and...