Search results for " clinical development"

Article A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Over the past several decades, numerous recombinant proteins have been approved as therapeutic drugs by regulatory authorities, and many more are currently undergoing clinical development (1). Chinese…

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 ADC Development Robust Despite Lackluster Performance
Some examples of ADCs in clinical development include candidates from Seattle Genetics, Immunomedics, and Roche. In addition, companies such as Mersana Therapeutics and Oncomatryx are using different …

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 Addressing the Challenges in Downstream Processing Today and Tomorrow
The standardization of cellular expression systems, bioreactor conditions, purification processes, manufacturing hardware, and disposables has resulted in faster clinical development and lower costs. …

Article Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals. The manufacture of biopharmaceuticals presents …

Article Building a Business Case for Biopharmaceutical QbD Implementation (Peer Reviewed)
However, others believe that the cost to start QbD-related experimentation is less than $1 million and the incremental effort to perform it during initial clinical development phases was about 6 perso…

Article Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes. By Susan Haigney natali_mis/Stock.Adobe.com Regulators have been encourag…

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 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…

Next Page