Search results for " preclinical development; clinical …"

Article Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.  By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani  Drug development is …

Article Bioterminology: A Guide to the Biopharmaceutical Lexicon
Bioterminology: A Guide to the Biopharmaceutical Lexicon This lexicon was generated by the editors of BioPharm International magazine. Please feel free to email your suggestions for terms that s…

Article Science Focus Fuels Successful Process Development for Startups
Getting the science right helps biopharma startups overcome development and commercialization challenges. By Cynthia A. Challener sdecoret/Stock.Adobe.com Pr…

Article Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech. By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…

Article Building a Business Case for Biopharmaceutical QbD Implementation (Peer Reviewed)
By Beth H. Junker. Beth H. Junker is the senior director of fermentation and development operations at Merck Research Laboratories ABSTRACT The aim of this paper is to de…

Article Key Considerations in Biosimilars Development
by:  Raymond Donninger, Joe Bower, Raymond Kaiser, Sian Estdale, John Carlsen Understanding opportunities and challenges across all major phases of development. Biosimilars…

Article The Importance of Partnering for Bioanalytical Studies
The Importance of Partnering for Bioanalytical Studies Yakobchuk Olena/Stock.Adobe.com  Bioanalytical studies are an important aspect of biologic drug development that may necessitate…

Article Can Vaccine Development Be Safely Accelerated?
Can Vaccine Development Be Safely Accelerated? Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe. By Cynthia A. Cha…

Article Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The biosimilars market, many analysts believe, is on the cusp of significant growth. This growth in large part is due to the fact that numerous monoclonal antibody (mAb) biosimilars are expect…

Article Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3 Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…

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