Raw and Starting Materials – Full SpotlightPublished: April 1, 2019
GUEST EDITOR: Rob Piperno, Director Cell and Gene Therapy QA, GlaxoSmithKline
As the cell & gene therapy space continues to grow at a rate of knots, there is perhaps no greater bottleneck on the horizon than the supply of critical raw materials. Add in the hefty contribution they can make to overall Cost of Goods, plus a dizzying array of technological, practical, logistical, regulatory and educational challenges, and you have a potential minefield. However, materials producers/suppliers and manufacturers of both autologous and allogeneic cell & gene therapies are bringing novel innovations to the fore to ensure that raw and starting materials can be a vital source of insight, confidence and competitive advantage.
- Troubleshooting apheresis and leukapheresis processes and management
- Interrogating the predictability of raw and starting materials to inform subsequent bioprocessing
- Regulatory compliance and standardization
- Next-generation raw materials (serum-free media)
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