Search results for " facility"
Article
Efforts Accelerate to Streamline Postapproval Change Process
…xperience, more postapproval changes are needed to increase batch size, shift to a new manufacturing facility, or improve process robustness and analytical methods.
Expanded global sourcing and s…
Article
Innovation vs. Capacity: How CMOs Compete
The strategies of an innovation-driven CMO may be different than a capacity-driven CMO.
By Jim Miller
While industry participants and observers talk about the “CMO industry,” they know that …
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Similar cell-culture media may be used simultaneously in one or few biological processes at a drug product manufacturing facility. As per Code of Federal Regulations (CFR) 211. 84, each media needs to…
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Platform Approach Speeds Process Development
A modular cell-culture platform demonstrates accelerated process development.
By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig
C…
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
In addition, it is quite expensive to develop more complex biosimilar mAbs, as much as a $200 million investment for one candidate, including the necessary mammalian cell culture facility built in com…
Article
Manufacturers Struggle with Breakthrough Drug Development
… noted, adding that it’s important to determine as early as possible if the clinical manufacturing facility can produce drug substance and drug product for launch. If no transfer of production is nee…
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Best Practices in Adopting Single-Use Systems
Users should specify components that are consistent with overall facility practices. For example, if commercial production relies on sterile welders and sealers, users should specify compatible tubing…
Article
Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
Human and process-related risks
There are two main potential sources of contamination, according to Cyrill Kellerhals, COO at Andelyn Biosciences: operators and the facility design. “Proper trainin…
Article
Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
The Fort Devens facility is a plant that you've had hands on experience with. Can you relate that or tie that into why the money was spent, why the investment was made and, overall, where sort of the …
Article
Pandemic Alters Policies and Practices for Drug Development and Regulation
By Jill Wechsler
The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.
Drug development and regulati…