Tuesday, January 28, 2020 Daily Archives

eBook: Joining Forces — Industry Collaborations Toward BioProcess Success

by and

Companies in the biopharmaceutical industry increasingly are working together to solve the many challenges of product/process development and biomanufacturing. Suppliers seek end-user help in refining technologies; academics and small innovators attract the financing and business acumen of large companies; equal partners share in technological problem-solving; and sponsors engage the development expertise of contract research and manufacturing organizations. Other examples of biopharma industry collaborations abound, too. Citing critical examples from the September 2019 BioProcess International East Conference in Boston, MA, this…

January 28, 2020

Biocon receives FDA Form 483 at Bangalore plant

by

The US FDA has issued Indian drugmaker a 483 with five observations following a pre-approval inspection of an API plant in Bangalore. [Story corrected 01/28 9am ET] – The US Food and Drug Administration (FDA) carried out the inspection at the site in Bangalore, India last week and issued a Form 483 with five observations. “We will respond to the FDA with a Corrective and Preventive Action Plan (CAPA) and are confident of addressing these observations expeditiously. We remain committed…

January 28, 2020