See how BioDlink’s digital-intelligence platform is driving three major improvements in lyophilization workflows.
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 ...
Globally Harmonized Regulatory Approach Is Needed to Move Forward Expeditiously The concept of well-characterized biologicals originated with the FDA Center for Biologics Evaluation and Research (CBER ...
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