Author Archives: Michael Merges

Accelerated Development Through Strategic Analytical Partnerships

The analytical field for biologics has evolved greatly over the past 30 years, and the underlying growth has shifted from biopharmaceutical companies to contract research organizations (CROs). The global biopharmaceutical market is growing annually at >15%, making it the largest and consistently fastest growing segment of the healthcare industry with annual sales in excess of US$200 billion. Contract manufacturing organizations (CMOs) are expanding capacity by building new cost-efficient facilities, reflecting market demand. Many product sponsors are outsourcing, some even increasing…

Accelerated Development Through Strategic Analytical Partnerships

The analytical field for biologics has evolved greatly over the past 30 years, and the underlying growth has shifted from biopharmaceutical companies to contract research organizations (CROs). The global biopharmaceutical market is growing annually at >15%, making it the largest and consistently fastest growing segment of the healthcare industry with annual sales in excess of US$200 billion. Contract manufacturing organizations (CMOs) are expanding capacity by building new cost-efficient facilities, reflecting market demand. Many product sponsors are outsourcing, some even increasing…

Benefits to Strategic Outsourcing of Biologics Analytical Studies

Michael Merges (director of Catalent Biologics), BPI Theater @ BIO, June 8, 2016, 1:40–2:00 pm Many small companies do not have the expertise or specialized technologies to do the necessary testing that underlies biologics manufacturing. Expertise is needed in microbiology, raw materials testing, characterization, and method development. At the same time, testing is taking place earlier in product development. Bioassays are the most outsourced service, and that is expected to continue. Catalent has over 25 years of experience in characterizing…