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Cell and gene therapies (CGTs) are the next wave of therapeutic innovation in the life sciences industry. From these constantly evolving technologies to highly complicated supply chains, advanced therapy manufacturing comes with its unique set of quality challenges such as:

  • Need for complete traceability to avoid patient/ product mix-ups
  • Stringent quality controls across internal and external stakeholders
  • Time-constrained and variable nature of manufacturing processes
  • Immature manufacturing technology
  • High reliance on specialized technical talent

So, as you move from basic therapy research to the clinic, and later to commercialization, it is vital you ensure process consistency, product quality and proper documentation throughout the manufacturing process and supply chain. If not, it could lead to serious quality events, delayed patient access and risk to overall patient safety. The risks are especially accentuated given the critical nature

Join this FDA News hosted session sponsored by ComplianceQuest where subject matter experts from Deloitte and Adicet Bio, a CGT company, discuss the challenges and opportunities in the digital quality transformation journey.

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