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Using a closure analysis method to reduce CGT contamination risks

Many cell therapy manufacturing processes use open unit manipulations. As a result, they are at risk of potential contamination that can result in manufacturing batch failure. The processes therefore rely on end-to-end aseptic processing to ensure the final drug product is safe and free of potentially harmful contamination. Addressing these risks has led BioPhorum to publish Cell and gene therapy closed systems – closure analysis of a mock...

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Closure analysis of a mock autologous cell therapy process

In its current state, cell therapy manufacturing comprises several open and manual operations which increase the risk of contamination. Members of BioPhorum’s Cell & Gene Therapy Commercialization workstream have generated a ‘mock’ process detailing the manufacture of a generic autologous CAR-T product operated through a series of process steps combining some open and some closed system elements. The mock process has undergone an end-to-end closure analysis to identify those operations that pose the highest contamination risks, and to provide suggested mitigation solutions to minimize such risks. Suggestions include options that are currently available, as well as potential future ‘desired state’ options. This paper details the full process and summarizes potential risks and possible mitigations. The primary aim of this paper is to demonstrate systematic application of a closure analysis method on an ex vivo gene therapy (also known as gene-modified cell therapy) process so that organizations can apply similar analyses to their own processes. The secondary aim is to propose process closure solutions that companies could implement in their own operations.

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Illuminating the challenges of validating cell and gene therapies

The validation processes for general biologics and small molecule drugs are well established and there are many guidelines from regulatory agencies to provide information and advice. However, much of this information is unsuitable for cell and gene therapies (CGT) and does not consider their unique characteristics.   This is why BioPhorum has published Cell and gene therapy validation challenges. In addition to highlighting the...

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Cell and gene therapy validation challenges

This paper highlights the numerous challenges in validating cell and gene therapy (CGT), drug substance (DS) and drug product (DP) manufacturing processes and analytical methods. It showcases some of the challenges associated with validation of viral vector-mediated gene therapy and gene-modified cellular therapy manufacturing processes and analytical methods validation and offers potential solutions for these. It aims to make readers more aware of the complexity and challenges associated with validating CGT products and the industry-wide consensus in addressing some of these to help drive regulatory acceptance.

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The essential digital capabilities for CGT manufacturing to succeed at scale

Cell and gene therapies (CGTs) is an emerging, high-growth area, but their manufacture is different from established small molecule and biologics platforms in many ways. These range from starter cell variability and traceability for patient safety, to the need for fast turnarounds, very dynamic scheduling and rapid deviation management. All of these, and more, profoundly affect the IT system requirements for CGT. As more CGTs are approved for...

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IT for CGT: Digital capabilities for cell and gene therapy

There are many differences in manufacturing cell and gene therapies (CGTs) compared to established small molecule and biologics platforms and this profoundly affects the IT systems requirements. Some products are personalized so the process includes personal screening and sequencing data, with traceability and data privacy throughout. Starter cell variability adds complexity to a manufacturing process that must have a rapid turnaround, very dynamic scheduling and rapid deviation management. Outcomes must be tracked for the long term to improve patient outcomes as well as to support novel reimbursement models.Industrialization of CGTs therefore needs the support of advanced systems for manufacturing execution, orchestration, traceability, scheduling, patient data and outcome tracking. Some processes will be encapsulated in closed systems, and there may be analytical requirements for continuous process verification and dynamic adjustment. Operators distributed across the globe will be supported remotely by augmented and virtual reality technologies. This paper helps executives and IT professionals to understand the IT needed to support CGT manufacture, and stimulates collaboration across the industry to meet these challenges.

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Mapping cell and gene therapy manufacturing

Cell and gene therapy (CGT) is a diverse field, with products and processes as varied as the patients it is trying to treat. As a relatively new group, the Commercialization Workstream in the CGT Phorum began by creating maps of the manufacturing processes for CGT; and what originally started as an internal exercise has grown into a valuable project that could benefit not only member companies but the industry as a whole. Creating the maps...

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