By Eduardo Schur, Justin Zamirowski, Atin Patel, and Maya Desai, Navigant
The number of new chemical entities gaining FDA approval more than doubled from 2017 to 2018. Global R&D spending increased 3.5 percent. The pipeline is strong, but how many innovations are actually reaching patients?
Glass breakage is commonly acknowledged as a major nuisance in parenteral manufacturing. It causes a plethora of problems, such as disruption of production, particle contamination, and loss of sterility.
By Rachel Kravitz, Wendy Vredenburgh, Victoria Chrostowski and Greg Bleck,Catalent
Combining Catalent’s GPEx cell line development technology with the Berkeley Lights, Inc. Beacon platform for clonal cell line selection resulted in stable, higher-expressing clones in a shortened timeframe.
By Deepa Raghu, Yu-Ting Hsu, Ludmila Kelly, Pamela Hamill, and Marian McKee,MilliporeSigma (Product Characterization)
It's crucial to evaluate the binding interaction of monoclonal antibodys (mAbs) with Fc receptors in the early phase of drug development to understand the potential biological activity of the product in vivo.
Key Biologics is harnessing new freezing technology to help deliver the future of medicine. Digitally enabled cryogenic cold chain technology can now deliver the raw materials needed to manufacture cellular therapies.