Search results for " 2015"

Article Design and Qualification of Single-Use Systems
28 (9) (September 2015) pp. 32-39. 12. D. Riedman and J. Martin, BioProcess Int. 9 (S2) (2011) pp. 28-35. 13. USP, (draft): Plastic Systems Used for Manufacturing Pharmaceutical Products, USP…

Article Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
The necessity to detach cells from a culture substrate during cell harvesting remains one of the most challenging steps in a cell-culture process. By Marcos Simon, Juan J. Giner-Casares Cell…

Article FDA Releases Draft Guidance on Emerging Manufacturing Technology
23, 2015, FDA released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. The guidance discusses the inclusion of a new FDA progr…

Article CMOs Concerned With Cost of Single-Use Equipment
BioPlan Associates, 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (Rockville, MD, April 2015), www.bioplanassociates.com/12th

Article Selecting a Comprehensive Bioburden Reduction Plan
69, (TR 69) Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations, published June 2015. Targeting Bioburden BioPharm: What type of planning is necessary to target all asp…

Article Taking a “Development-by-Design” Approach to Cell Therapies
Jun 15, 2015 By Agnes Shanley BioPharm International eBooks Volume 28, Issue 13 Whether outsourcing or developing cell therapies in-house, success demands a focus on quality, c…

Article Biopharma Advances Demand Specialized Expertise
Jun 15, 2015 By BioPharm International Editors BioPharm International eBooks Volume 28, Issue 13 Contract service providers share insights on biopharma market developments and the impl…

Article Optimization of Protein Expression in Escherichia Coli
May 01, 2015 By Siavash Bashiri, David Vikström, Nurzian Ismail BioPharm International Volume 28, Issue 5 Production of proteins for manufacturing therapeutics and pharmaceuticals is a c…

Article Use of Multivariate Data Analysis in Bioprocessing
Apr 06, 2015 By Anurag S. Rathore, Sumit K. Singh BioPharm International The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare costs have motiva…

Article Ligand-Binding Assays and the Determination of Biosimilarity
Challener, "Ligand-Binding Assays and the Determination of Biosimilarity," BioPharm International, Vol 28 (1) 2015.

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