Biologics APIs

Feb 01, 2016
Pharmaceutical Technology
Sustainable harvesting combined with CMO expertise helped Centroflora CMS ensure supply continuity after it acquired Boehringer Ingelheim's non-captive API phytochemicals portfolio.
Jan 28, 2016
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
Novasep is building a new synthesis laboratory and adding capacity for kilogram-scale batches of synthetic molecules that are needed for biological testing and preclinical trials, at its Pennsylvania, US facility.
Jan 02, 2016
Pharmaceutical Technology
FDA approved 45 novel new drugs in 2015, the highest number of approvals since 1996 and second-highest ever.
Dec 02, 2015
Pharmaceutical Technology
A strong API market is expected in 2016 despite fewer new drug approvals.
Sep 08, 2015
Pharmaceutical Technology
A study of recent inspection observations allows for baseline trending and continuous improvement.
Aug 02, 2015
Pharmaceutical Technology
Findings from a study on import testing, based on data collected from six multinational pharmaceutical companies, suggest that import testing does not add significant benefits to the quality or safety of drugs, provided that the products are uninterruptedly controlled according to the globally harmonized manufacturing and distribution standards.
Aug 02, 2015
Pharmaceutical Technology
Potential for improved product quality and cost/time savings is reviving interest in perfusion technology.
Aug 01, 2015
Pharmaceutical Technology
Ignoring a contract partner’s ability to handle highly potent APIs (HPAPIs) safely may have serious consequences. Drug owners and contract service providers alike must understand the complexities and liabilities involved in working with HPAPIs.
Jul 07, 2015
By Pharmaceutical Technology Editors
Catalent licenses Excelimmune’s antibody combination therapy platform toenable the manufacture of multiple recombinant antibodies in a single batch culture.
Jul 02, 2015
Pharmaceutical Technology
Biologics exhibit greater variability in stability testing than do small-molecule drugs, and maintaining a stable test environment is crucial.
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