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Article Managing Biomanufacturing Capacity Expectations
Capacity for complex therapeutics is becoming increasingly difficult to predict. By Randi Hernandez Demand for any given new product is typically only known after significant investments h…

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 Vaccine Development Faces Urgency and Challenges
Global outbreaks energize vaccine R&D and drive production modernization. By Jill Wechsler The Ebola outbreak in 2015 and the current stampede to develop a new vaccine to combat the Zika vir…

Article Framing Biopharma Success in 2016
Corporate restructurings, regulatory initiatives, and biosimilars will shape biopharma development in 2016. By Rita C. Peters The US biopharmaceutical industry turned a new page in 2015 when…

Article mAbs to Watch in 2016
By Randi Hernandez Of the 45 new molecular entities and new therapeutic biological products approved by FDA in 2015, nine products were monoclonal antibodies (mAbs). And there may be many more o…

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 Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
By Leonard P. Freedman, Mark C. Gibson, Richard M. Neve Irreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays and increased costs of …

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 Advanced Technologies Facilitate Scale-up and Technology Transfer
Single-use and modular technologies plus continuous manufacturing are increasingly important to biopharma scale-up and tech transfer. Jun 01, 2015 By Cynthia A. Challener BioPharm Inte…

Article Drug Discovery and Development in India
Apr 01, 2015 By Jane Wan BioPharm International Volume 28, Issue 4 Indian pharmaceutical companies’ entry into the drug discovery and development field dates back to the early 1990s …

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