Search results for " Biopharm"
Article
Fermentation for the Future
Jan 01, 2015
By Cynthia Challener, PhD
Microorganisms—bacteria and yeast—have been widely used for the production of genetically engineered (recombinant) biopharmaceuticals. Typical examples…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The use of disposable equipment in the biopharmaceutical industry is rapidly increasing, as it offers advantages in terms of flexibility, elimination of cleaning procedures, and reduced capital expend…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
Challener, PhD, is a contributing editor to BioPharm International.
Article Details
BioPharm International, Vol. 28, Issue 1
Pages: 36-39
Citation: When referring to this article, plea…
Article
Improving PAT for Biologics
Advances in high-throughput systems, Raman and near-infrared (NIR) spectroscopy, high-performance single-use sensors, and chemometric methods are also helping manufacturers of biopharmaceuticals overc…
Article
Biopharma Manufacturers Respond to Ebola Crisis
Most discussed is the ZMapp cocktail of three monoclonal antibodies from Mapp Biopharmaceutical of San Diego, which made headlines when two American health workers infected by Ebola recovered followin…
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
Amy Ritter, Scientific Editor at BioPharm International, spoke with Dr. Howard Levine, President and Principal Consultant of BioProcess Technology Consultants, about what these guidelines mean for dev…
Article
Quality by design for biotechnology products—part 1
Therefore, this paper offers guidance and interpretation for implementing QbD for biopharmaceuticals, from early-phase development steps such as identifying critical quality attributes and setting spe…
Article
Sterilization Trends for Single-Use Consumables
As the biopharmaceutical market continues to expand and reliance on single-use manufacturing rises, demand for SU consumables—bags, containers, filters, tubing, etc.—is also increasing. The value of t…
Article
Reviewing the Importance of Biosimilarity and Interchangeability
…ty compared to the reference product, says Olaf Stamm, PhD, technical business development director, Biopharmaceutical Testing Solutions, Charles River Laboratories.
Among these criteria are comp…
Article
Top challenges in recombinant protein purification process development
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Transcript
Jeanne Linke Northrop: Hello, I'm Jeanne Linke Northrop with BioPharm International, and I'm joined today by Emma Lind, Global Product Manager for resins and techno…