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Fast Tracked Gene Therapy Shipping Qualification for BLA

Fast Tracked Gene Therapy Shipping Qualification for BLA

by Lean Biologix | Aug 22, 2022 | Supply Chain Testing

A global biotechnology company working toward regulatory approval of a gene therapy treatment was required to perform shipping validation to support review and approval in the US market. As the primary indication was targeted for fatal neuromuscular genetic disease...
Overcoming a Challenging In-Country Distribution Model

Overcoming a Challenging In-Country Distribution Model

by Lean Biologix | Aug 22, 2022 | Supply Chain Testing

A leading fortune 500 company headquartered in Cambridge, MA was planning to launch a number of biological products into new markets for the first time. Product specific shipping qualification was performed and qualified shipping containers were in use for domestic...
CDMO Platform Shipping Strategy/Qualification

CDMO Platform Shipping Strategy/Qualification

by Lean Biologix | Aug 5, 2022 | Supply Chain Testing

A leading cell and gene therapy CDMO located in Cambridge, MA desired to qualify and implement platform shipping systems that could maintain their product requirements and regulatory compliance.   Challenges Aggressive timeline to complete qualification and...

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    • Supply Chain Testing
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    • GxP Computer Systems Validation
      • Optimal synTQ Consulting
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