FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
News|Articles|November 20, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
- PTSM: Pharmaceutical Technology Sourcing and Management-12-02-2015
- Volume 11
- Issue 12
Catalent Expands Biologics Capabilities
Author(s)Pharmaceutical Technology Editors
Expansions at Catalent’s Kansas City, MO, and Madison, WI facilities made in response to industry demand.
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Catalent Pharma Solutions has announced the multi-site expansion of its analytical and process development capabilities for biologics including include an expansion of bioassay and protein characterization capabilities at its Kansas City, MO, facility, and additional integrated analytical capabilities at its Madison, WI, bio-manufacturing facility.
The investments were made in response to increased industry demand for large molecule analytical services, regulatory expectations around NBEs, and additional characterization requirements for biosimilars, the company reported in a Nov. 20, 2015 statement. The investment in Kansas City enables the facility to offer dual and complementary options for kinetic and quantitative binding assays for characterization and GMP testing.
The expansion at the Madison site will be operational by January 2016. The company has expanded process development capability at the Madison site, including integration of the Ambr 15 microbioreactor system into its cell line and upstream development.
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