Cell & Gene Therapy

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Addressing the challenges of using RNA as a therapeutic or a gene-editing tool

RNA technologies, including mRNA therapeutics, have emerged as a promising drug modality due to their essential biological role in protein expression and their potential versatility in manufacturing. As a result, RNA is in the global spotlight and is being prioritized due to the Covid-19 pandemic. To maintain the current momentum as industry returns to a ‘normal’ cycle of drug and therapy development, BioPhorum experts have come together to...

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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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A simplified way to register complex and innovative raw materials in Europe

The regulatory environment for registering innovative and complex raw materials differs by region and country. All national health agencies need to ensure that products proposed for their markets are safe, effective and of appropriate quality, so they need sufficient information to make that assessment. Most national health agencies have a knowledge platform where raw material suppliers can provide information on non-compendial materials –...

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Release specifications for master cell banks – your chance to make a difference

Gene therapy (GT) is a rapidly expanding field that could potentially revolutionize curative treatments and is an exciting new way to help patients. The number of GT processes is wide and varied, yet current regulations and guidance are not always detailed enough for industry needs. Industry is looking for initiatives to increase the speed of learning and, ultimately, influence regulatory agencies when creating guidance and policies around GT...

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BioPhorum launch new sustainability phorum

BioPhorum members have given us a clear message; to be an industry that supports sustainability is extremely important to them. With no other single organization providing ‘one voice’ for the industry, discussions have been gathering pace to launch a dedicated sustainability phorum. This will become the prime vehicle to translate high-level corporate statements and commitments into practical, on-the-ground, scalable and transferable solutions....

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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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How to assess EHS risks for commercial-scale CGT manufacture

The rapidly expanding field of cell and gene therapies (CGT) has the potential to revolutionize curative treatments. However, among the many hurdles ahead are that occupational health and safety guidelines for the manufacture of CGT products have been lacking and there is no clear framework for considering risks for operators when working at a commercial scale. The result is that there is no ‘universal’ biosafety risk assessment template for...

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Driving progress in Cell & Gene Therapy

Now with 19 member companies and 183 subject matter experts, the BioPhorum Cell & Gene Therapy (C&GT) Phorum has made great strides since its formation in 2018. The Phorum has a growing list of goals for the next 12–18 months and the team will use its combined strength to accomplish these. The Phorum aims to support the faster delivery of C&GT products to market, by lowering business and supply chain risk, and accelerating...

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