Cell & Gene Therapy

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Commercialization: Gene therapy process map

Commercialization: Gene therapy process map

Viral vector manufacturing is a relatively nascent field, with companies working in many different therapeutic areas, and employing a wide range of processes and procedures. Therefore, members of BioPhorum’s Cell & Gene Therapy Commercialization workstream has generated a set of gene therapy process maps that represent example processes, unit operations and platform technologies being used within in vivo gene therapy manufacturing. These gene therapy process maps are intended to be used as an initial introduction to the in vivo gene therapy manufacture processes and so act as an educational tool for people new to the field. They are also intended to form a general platform baseline for scientists and engineers working within the field to support collaboration enabling process improvements and accelerating commercialization of viral vector manufacturing.

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Commercialization: Gene therapy process map

Commercialization: Cell therapy process map

Standard methodologies for generating therapeutic cell products (with or without gene modification) continue to change as the field matures. BioPhorum has identified significant gaps in publicly available information describing industrial practices for production of cell and gene-modified cell therapies. Therefore, members of BioPhorum’s Cell and Gene Therapy Commercialization workstream have generated a series of cell and gene-modified cell therapy process maps that represent example processes, unit operations and platform technologies being used in manufacturing today. These maps are intended to be used to form a common frame of reference for scientists and engineers
working within the field and support collaboration to enable process improvements benefitting future cell therapy patients by supporting acceleration of commercialization of novel modalities. They are also intended as an education tool for new members to the cell therapy field.

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IT for CGT: Digital capabilities for cell and gene therapy

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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EHS: Environmental health and biosafety risk assessment framework for commercial scale cell and gene therapy manufacturing and template

EHS: Environmental health and biosafety risk assessment framework for commercial scale cell and gene therapy manufacturing and template

This paper and supporting template identifies, shares and enhances best practices and standards, improves risk controls and increases the speed of learning. It discusses a general process designed to provide a risk assessment framework and contains a ready-to-use template. This highlights the complexity of commercial-scale manufacturing as well as considering the areas to assess, potential questions to ask while assessing them, and the other parties who may have pertinent input to the overall risk assessment.

The template can form the basis for discussions between a contract manufacturer and client, or between production and development departments. The aim is to address the following questions when evaluating the CGT manufacturing process: What could go wrong? What controls are in place and are they enough? What did we learn from this?

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