Although some aspects of process validation for continuous processes are the same as those for traditional batch processes, there are some unique considerations. Although some aspects of process ...
3P Biopharmaceuticals, a leading CDMO specialized in the process development and GMP manufacturing of biologics has, together with the Swedish biotechnology company Intervacc AB and LIOF-Pharma ...
On July 2, 2015, the Court of Appeals for the Federal Circuit held that a patent owner’s use of a contract manufacturer (CMO) to prepare validation batches of a drug formulation for submission to FDA ...
The authors desribe the three-stage approach to validation that is outlined in the new guidance and discuss questions surrounding implementation. The regulatory basis for process validation is ...
TYSONS CORNER, VA, June 29, 2017 ” Another batch of Iridium Communications (Nasdaq: IRDM) satellites has been launched Sunday to join a growing constellation that will work to provide L-band satellite ...
Moscow, February 26, 2021 – The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), Generium, a high-end Russian pharmaceutical company, and Belmedpreparaty, the leading ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback