Search results for "biotech" in Articles / App Notes

Article 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
…re 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 ant…

Article 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…

Article A Bright Future for the Plasma Fractionation Industry
That was one of the conclusions reached when the 9th Plasma Product Biotechnology (PPB) meeting ended on the beautiful island of Sardinia, Italy in mid-May. This meeting series, which is a joint organ…

Article Tackling Analytical Method Development for ADCs
… both fields to forge integrated techniques that will bridge the knowledge gap and blend pharma and biotech platforms, and the interface of these analytical techniques allows real understanding of th…

Article Improving PAT for Biologics
…rio Becker, director of marketing and product management for PAT and automation at Sartorius Stedim Biotech. Because bioprocesses are complex and dependent on multi-factor interactions between the…

Article Trends in Single-use Bioreactors
…bsp;Cytiva; and Mikel Sherman, global product manager of single-use bioreactors at Sartorius Stedim Biotech GmbH. Latest innovations BioPharm: What are some of the latest innovati…

Article Continued Process Verification for Biopharma Manufacturing
CMC Biotech Working Group,A-Mab: a Case Study in Bioprocess Development(Oct. 30, 2009), accessed Sept. 16, 2014. 4. From presentation at 10th APIC/CEFIC meeting, “FDA’s Quality Initiatives—An Upda…

Article Application of Quality by Design to Viral Safety
40-47  The biotech industry has begun to implement a quality-by-design (QbD) approach to ensure the quality of biopharmaceuticals. Using this approach, products are developed with a thorough under…

Article Healthcare Reform in China
Companies can also explore the option of collaborating with partners in China or teaming with local biotech companies and research institutes. In addition, opportunities can be found in the generi…

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