Search results for " 2018"
Article
The Outlook for CMO Outsourcing in 2019
FDA approved approximately 25 new biopharmaceuticals in 2018 (1), and the number of annual approvals is expected to increase in coming years, as new classes of products receive approvals, particularly…
Article
A Plastic Pipeline for Commercial Bioprocessing?
In January 2018, Fujifilm announced the qualification of its Saturn mAb Solutions facility in College Station, TX for cGMP production of monoclonal antibodies. The building was designed to accommodate…
Article
Leveraging Data for Better Biopharmaceutical Process Control
…d software vendor based in Portugal, which she defended at the University of Copenhagen (1) in March 2018.
As she sees it, biopharmaceutical companies are now developing the mindset that will…
Article
Supply Chain Challenges for Single-Use Systems
In September 2018, MilliporeSigma announced its first Mobius single-use manufacturing facility in Wuxi, China would begin production in 2019 (2), and in November 2018, Cytiva announced a collaboration…
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
20, 2018.
3. R. Saldova, et. al, Mol. Oncol. 11 (10), 1361-1379 (2017).
4. M. Doherty, et. al, Sci. Rep. 8 (1) 8655 (2018).
5. A. Kobata, Proc. Jpn. Acad., Ser B. 89 (3), 97-117 (201…
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3rd BioProcessing Asia Preview: Q&A with John Curling
We believe that attending BioProcessing Asia 2018 will provide a unique opportunity for participants to meet with and learn from key industry and academic leaders. Attendees will leave with new knowle…
Article
Cell-free Expression Systems Pose Cell Culture Alternative
Cell-free expression is promising in preclinical applications, but still presents challenges to scale up for commercial production.
Feliza Mirasol
Among the challenges in upstrea…
Article
Leveraging Computational Models of Glycosylation for Biopharma QA
Close collaboration between academic and industrial groups is vital to ensuring glycosylation models are fit for deployment.
By Ioscani Jiménez del Val
Good Studio/S…
Article
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
CBER is receiving dozens of applications to test new gene therapies, Marks reported at the Cell and Gene Therapy symposium in July 2018, sponsored by CASSS. He acknowledged that the logistics of manuf…
Article
Modern Manufacturing Key to More Effective Vaccines
FDA is applying lessons learned from Ebola to streamline vaccine development, noted Philip Krause, deputy director of CBER’s Office of Vaccine Research & Review (OVRR), at the January 2018 WCBP sympos…