Shawn Cain Cain BioConsulting, LLC

Shawn Cain is currently the Principal at Cain BioConsulting, LLC and is supporting PCI Pharma Services, Inc. Mr. Cain has over thirty years of experience in combining process engineering and project management to direct the development and commercial manufacture of sterile pharmaceuticals, cell-based biologics, and medical devices. Previously, he was the COO of LSNE, which was acquired by PCI. Mr. Cain also worked at Organogenesis and was the Director of Operations for another pharmaceutical CDMO, Formatech, Inc. Prior to that, he was Interim President and Chief Executive Officer of Arbios Systems, Inc., and was also employed at Becton Dickinson’s Biologics Division. Mr. Cain was previously the Vice President of Operations for Circe Biomedical, Inc., where he led the development of the bioartificial liver technology. Mr. Cain holds six patents, has published many papers, received his M.S. degree in Biological Sciences from the University of Massachusetts and a B.S. in Biological Sciences from Northeastern University.

Outsourcing the Manufacture of your Lyophilized Aseptic Product

Whether you have years of experience with aseptic manufacturing of drug products or if this is your first time, come hear Shawn Cain, the Chief Operating Officer of LSNE Contract Manufacturing, provide his valuable insight into the technical transfer and aseptic manufacturing of your lyophilized drug product. This presentation will discuss finding the right CDMO partner, transition to cGMP from the lab, scale up, disposable technology versus dedicated equipment, a phased based approach to your development and analytical requirements, planning and time considerations, and having a robust regulatory strategy. He’ll also provide a number of “watch outs” for you to look for as you bring your lyophilized product to market.