Utilizing Microgravity to Develop Crystalline Monoclonal Antibodies for Subcutaneous Delivery

Robert Garmise, PhD, earned a PharmD from Duquesne University and PhD in Pharmaceutical Sciences from the University of North Carolina-Chapel Hill. Dr Garmise is an Associate Director, leading the Novel Materials and Processes Group at Bristol Myers Squibb in New Brunswick, NJ. He partners with key stakeholders to define unmet materials science and engineering needs in areas such as packaging, devices and biologics. Dr Garmise is the Principal Investigator for “Structural and crystallization kinetics analysis of monoclonal antibodies”, which launched on SpaceX-21 in December 2020 and “Screening and Batch Manufacture of Complex Biotherapeutics in Microgravity”, which is targeting launch on SpaceX-27 in January 2023.

Paul Reichert is an Associate Principal Scientist in the Structural Chemistry Department at Merck Research Laboratories (MRL). He has been conducting pharmaceutical research for 35 years working at MRL on the discovery and development of small molecule and macromolecular therapeutics. His expertise is primarily in the crystallization of proteins and biologics to better patient treatment options for efficacy, safety, adherence, and compliance.   Mr Reichert has over 25 pharmaceutical application patents of crystalline proteins and is also the author of over 31 papers on the development of biologic therapeutics. For 15 years, in collaboration with NASA and the University of Alabama at Birmingham, Mr Reichert has had both advisory and scientific roles. He was a member of the Science Advisory Group for NASA's Iterative Biological Crystallization Group at Marshall Space Flight Center. He has been a principal investigator for eleven microgravity experiments on Space Shuttle flights as secondary payloads. These experiments were designed to explore microgravity effects on multiple pharmaceutical applications primarily using alpha interferon (Intron A™). These patient-centric applications included structure determination, drug delivery and the purification of protein therapeutics with implications for health economics and outcomes. Currently, besides his work at MRL, Mr Reichert is a principal investigator in collaboration with CASIS and has performed experiments for crystallization of therapeutic monoclonal antibodies on Space X-CRS-3, 6, 10 and 24 missions to the International Space Station (ISS). Most recently, his monoclonal antibody crystallization experiment launched on board SpaceX-CRS-24 December 21st 2021and was recovered on January 24, 2022.  Biophysical and biochemical characterization studies are ongoing.