Search results for " biotech"
Article
Managing Biomanufacturing Capacity Expectations
Wyss estimates that almost all biotech companies that have several products on the market use a mixed approach to manufacturing, but most companies keep the number of CMOs that they work with to a min…
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A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
One sign of progress was the opening of a JHL Biotech flexible manufacturing facility in Wuhan, China on May 10, 2016, for the manufacture of biosimilars and monoclonal antibodies (mAbs). The facility…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
For example, for a small biotech that was particularly concerned about reducing capital expenditure, the ultimate recommendation was to buy-in ready-made buffer and media in single-use liquid delivery…
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Platform Approach Speeds Process Development
Recently, miniaturized disposable small-scale bioreactor systems such as the ambr15 and ambr250 (Sartorius Stedim Biotech) became integral parts of fast-track process development strategies as enablin…
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Vaccine Development Faces Urgency and Challenges
GSK, Pfizer, Merck, Johnson & Johnson, and Takeda, as well as several smaller biotech firms, are examining vaccine research portfolios for potential candidates to combat Zika.
Anthony Fauci, direc…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Potential applications of new technologies for the characterization of transgenes
As the biotechnology industry continues to mature, so does the ability to understand the processes used to manufact…
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KUBio modular biopharm facility built in Germany, assembled in China
Cytiva is supplying a full biopharmaceutical processing solution, known as a KUBio, to JHL Biotech in Wuhan, China. The sixty-two completed modules that make up the factory have completed the journe…
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Implications of Cell Culture Conditions on Protein Glycosylation
ICH, Q6B, Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, Step 5 version (Sept. 1999).
About the Authors
Michiel E. Ultee, PhD, is principal at …
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
…are several additional antibody formats currently in the development pipelines of pharmaceutical and biotech companies. One of these promising groups of antibodies is called bispecifics, where one an…
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Selecting a Comprehensive Bioburden Reduction Plan
Kathleen Souza, senior microbiologist in the Department of Virology and Microbiological Sciences at EMD Millipore, and Nick Hutchinson, market development manager, pharma and biotech at Parker domnick…