Welcome to Alston & Bird’s introduction to biological products regulation. In this five-part intro-level series, we provide answers to a number ...
In the past, product characterization was simple and standardized. Developers of small molecule pharmaceuticals performed a battery of tests around Phase II or III clinical trials, fulfilled the ...
The market for insulin and certain other biological products may change in the coming months and years, as a provision in Biologics Price Competition and Innovation Act (BPCIA) goes into effect on ...
Biologics are diverse, organic-based treatments like vaccines and gene therapy, requiring specific conditions for effectiveness. Unlike small molecules, biologics show batch variability and involve ...
WuXi Biologics reports that it has successfully launched the GMP operation of its new drug product facility located in Wuxi, China, which is the eighth operational drug product facility in the global ...
SEATTLE--(BUSINESS WIRE)--AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced a new service agreement with Medigene AG ...
Using same proprietary, patented technology, VIVI Med extends the product portfolio beyond injectable pens, opening access to broader patient populations, premium ...
WuXiUI™ ultra-intensified fed-batch platform offers a new process option for maximum flexibility to meet various clients' needs in biologics development and manufacture. The platform can significantly ...
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