Panelists from FDA, Genentech, and Minaris discussed raw material risk, supplier oversight, and at-risk release strategies for advanced therapies at the PDA/FDA Joint Regulatory Conference.
|Articles|May 15, 2017
- BioPharm International-05-15-2017
- Volume 2017 eBook
- Issue 1
CMOs Tackle New Challenges
Author(s)Randi Hernandez
BioPharm International speaks with a CMO to find out how it is coping with capacity challenges, regulatory authority scrutiny, supply chain reliability, and new requests from clients to incorporate continuous manufacturing into processing lines.
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Demand for biologic drug processing is placing pressure on contract manufacturing organizations to meet capacity demands in a timely manner. Christoph Winterhalter, senior vice-president of business development at Rentschler Biotechnologie GmbH, discusses the ways the company is prepared to handle new challenges related to client requests and heightened scrutiny from regulatory authorities.
from BioPharm International’s 2017 Outsourcing Resources eBook.
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Articles in this issue
over 9 years ago
Customer Relationship Management in Contract Manufacturingover 9 years ago
Getting Biopharmaceutical Tech Transfer Right the First Timeover 9 years ago
Gearing Up for Biosimilarsover 9 years ago
Insourcing vs Outsourcing: Choosing the Right Strategyover 9 years ago
Operations and Quality Oversight of CMOsover 9 years ago
Quality Metrics and CMO AgreementAdvertisement
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