Search results for " biopharms"

Article An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…

Article A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
Bioprocessing equipment and materials, as well as technical discussions about process development, were in prominent positions at the INTERPHEX 2016 trade show, held in New York in late April. Rita …

Article A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media. By Satish Mallya, Benjamin Lay, Lihong McAleer, Alexa…

Article A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells. By Luhong He, Christopher Frye Abstract …

Article Selecting the Right Viral Clearance Technology
By Cynthia Challener, PhD The introduction of adventitious viral agents is a recognized, inherent risk of biologic drug production that is well addressed by international regulatory requirements…

Article Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Surface plasmon resonance is helping define bispecific antibodies, the next-generation of biopharma therapeutics. By Robert Karlsson Abstract Biotherapeutic antibodies are still the larg…

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
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 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…

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