MANUFACTURING
Cold-Chain Considerations for Manufacturing today’s Advanced Biologics Cold Chain Integrity and Capabilities The ways CDMOs exhibited flexibility and agility to overcome the challenges of mRNA vaccine production. Examining the lessons learned, he provides his perspective on the strategies taken to deliver a better program and highlights the importance of remembering key lessons as we move forward. Lee Seungheon Product Logicstics Specialist, Samsung Biologics
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he biopharmaceutical industry’s reliance on the technical experience and manufacturing capacity of contract pharma continues to grow as demand for all biologic drugs surges around the world. Manufacturing advanced biologics compliantly requires mastery of aseptic containment, as well as temperature-controlled cold-chain systems for product integrity and quality. Most biologic modalities require temperature-controlled environments and packaging solutions to preserve product integrity and assure safety quality and efficacy. It also requires operational excellence and an understanding of every aspect of commercial biologic drug substance and product manufacturing to it. The COVID-19 pandemic highlighted the challenges of ultra-low temperature storage and distribution as messenger RNA (mRNA) technologies required exacting cold-chain temperature controls at every step and highlighted the challenges of ultra-low temperature storage and
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P H AR M A F O C U S E U R O PE
ISSUE 01 - 2022
