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Building solid foundations for aseptic process simulation

31 May 2023
Advanced Therapy Medicinal Products
Simon Walker
Global Change Facilitator

Aseptic process simulation (APS) plays a critical role in demonstrating processes, equipment, and materials involved in sterile manufacturing work together in synergy to maintain sterility (e.g., facility/air handling units, gowning procedures, and personnel). However, what makes developing APS programs for advanced therapy medicinal products (ATMPs) even more complicated is the limited acquired ‘know-how’ due to the relatively short history of ATMP production with only a few licensed products.

Unfortunately, guidelines on APS design for ATMPs are not well established; in particular, ATMPs do not necessarily start from a sterile starting material. Existing guidelines are also difficult to translate and apply to cell and gene therapy (CGT), so each company must work in isolation to assess and fill the gaps.

Therefore, industry needs new approaches to how APS requirements can be practically met in the ATMP sector while ensuring patient safety is not compromised.

This is where BioPhorum’s new paper, Cell and gene therapy aseptic process simulation reflections will play a major role. It reviews and identifies gaps in existing guidelines on APS for ATMPs, outlines technical limitations and challenges, and provides recommendations on design and how some of the existing challenges may be addressed through risk-based approaches.

Adam Bartley, Vice President Technical Operation at Editas Medicine, said, “The paper gives us a chance to take all policies and procedures in place, review them to see where the gaps are, and identify any additional risk assessments before expanding into a larger footprint. Getting this right is critical to all of our patients.”

An operator focus

Two key areas we discuss are the intrinsic vs. extrinsic contamination principle (e.g., for autologous cell therapies) and the development of operator-specific qualification since many ATMP processes are still highly manual.

“One important element of the paper is having a different approach toward how operators are qualified, with the concept of operator-specific APS and different qualification types for the different grades (Grade A, B, etc.),” said Friedrich von Wintzingerode, QC Lead at Roche. “This is exactly the discussion you need to have when setting up a new facility and when implementing Annex 1 following a risk-based approach.”

The section that references other documents and relevant guidelines will be of significant benefit to you as it brings this information together all in one place. Our paper lets you develop your best practice APS approach by leveraging the collective knowledge of the companies that input to the document – it is written by people who have designed APS protocols and have extensive ‘on the floor’ knowledge. This is an excellent jumping-off point for those new to the field.

The paper is aimed at those in manufacturing science and technology, and quality control – but generally anyone with a CGT program in an early or later phase. It allows you to bridge the gaps you may have identified but do not know how to confirm you are on the best path forward.

“The most important piece of any building is its foundation,” added Bartley. “At the core of all CGT companies’ success is APS. This paper ensures everyone builds their foundations with the same stability and strength.”

For more information, download the paper here and contact Simon Walker, Global Change Facilitator, at simon.walker@biophorum.com

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Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products support the quest for better and faster development of cell, gene and RNA therapies​ through connecting therapy developers, contract manufacturing, and testing organizations to gain an understanding and respond to the challenges faced by the advanced therapeutics industry.

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Drug Substance advances excellence in drug substance manufacturing and testing, acting as an industry voice to accelerate technology adoption, implement post-approval change more rapidly and increase confidence in maintaining compliance.

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