23rd Annual CBE Graduate Student Research Symposium

At Lyndra Therapeutics, our team is developing an ultra-long controlled drug release platform to address unmet medical needs and improve patient adherence.  The “stellate” (i.e. star) is a revolutionary encapsulated oral product designed to ensure long term gastric retention and controlled release of life saving medication(s). The manufacturing process to make a stellate is complex. Briefly, the center of the stellate is an elastomeric “core”. To manufacture the stellate arms, polymeric materials and active pharmaceutical ingredient (API) are dry blended and hot melt extruded into rods. These rods are then cut and coated to control drug release rates. Final assembly of the stellate is completed by joining the components together. The final stellate is folded and encapsulated for administration to patients. Given the technical complexity, chemical engineers at Lyndra are overcoming many challenges daily, towards the shared goal of having a robust, scale-able and high volume process for manufacturing the stellate product for commercial production. This presentation will highlight a few of these challenges and more.   

Dr. David Geer has worked over 15 years in the biopharmaceutical industry in the areas of process development and commercialization of live virus vaccines, biological and small molecule drug products. David started his professional career at Merck and Co., Inc with the responsibility for technical support and project leadership during late stage product development.

Over the years, he has contributed to many novel therapies serving global unmet medical needs such as GARDASIL®, the first vaccine for cervical cancer and KEYTRUDA®, the first FDA-approved anti PD1 immunotherapy medicine for melanoma and lung cancer. In 2017, David joined Shire / Takeda where he was Director of External Technical Operations supporting manufacturing of commercial products, process optimizations and troubleshooting quality deviations. Recently, David joined Lyndra Therapeutics as Head of Manufacturing Science and Technology and his team is focusing on development of an exciting oral dosage form technology for ultra-long controlled drug delivery of small molecules. David currently resides in Perkasie, PA.