Cell & Gene Therapy

Viewing related articles

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...

read more

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....

read more

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...

read more

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...

read more

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...

read more

Cell and Gene Therapy’s formula for success

When you get the right people working together and engaged in the right subjects, it is the formula for accelerating change within the industry. This is what has been developed within the Cell and Gene Therapy phorum in the build up to their second face-to-face meeting in Texas on 14-15 November 2018.

read more