Search results for "biopharm" in Articles / App Notes
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Strother, European Biopharm. Rev. EBR 12 (169) article 3215, (2012).
8. H.W. Lee et al., Biotechnol. Prog. 28 (3), pp. 824–832 (2012).
9. A.O. Kirdar, G. Chen, and A.S. Rathore, Biotchnol. Pro…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
…prove recombinant protein production to meet the demands of high quantity and consistent quality of biopharmaceutical products. Those efforts can be categorized into two fundamental areas: improving …
Article
Selecting the Right Viral Clearance Technology
Many methods to choose from
There are numerous methods that can be employed to achieve viral clearance during downstream biopharmaceutical processing, some that are better understood than others. …
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Mitchell, BioPharm Int. 12 (26), pp. 38-47 (2013).
6. ICH, Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, Step 4 version (Septemb…
Article
Aseptic Processing: Keeping it Safe
By Randi Hernandez, BioPharm International
Humans represent the greatest risk for microbial contamination in an aseptic process.
Aseptic processing has garnered some increased scrutiny…
Article
USP Stresses Pharmacopeial Standards at CPhI China
Jun 29, 2015
By BioPharm International Editors
The United States Pharmacopeial Convention (USP) hosted a pharmacopeial and regulatory compliance seminar at the 2015 CPhI China conference, he…
Article
Use of Multivariate Data Analysis in Bioprocessing
Singh
BioPharm International
The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare costs have motivated biotech manufacturers to focus on process opti…
Article
Vaccine Development and Production Challenges Manufacturers
Mar 01, 2015
By Jill Wechsler
BioPharm International
Volume 3, Issue 28
Vaccines are front-page news these days. Researchers are advancing new vaccines for Ebola and other devastating di…
Article
FDA Approves First Biosimilar
She said that some biopharma companies fail to establish a strong foundation of analytical data to ensure sufficient similarity, and may have to redo pharmacology studies and other trials as a result.…
Article
Labeling of Biosimilars
Feb 01, 2015
By Sean Milmo
BioPharm International
The European Medicines Agency (EMA) has reached a key stage in the lengthy process of creating a regulatory framework for the development and…