Associate Director Evonik Inc. Piscataway, New Jersey
Polylactide and polylactide-co-glycolide controlled release polymers have been used for long-acting injectable formulations. These polyesters polymers are bio-compatible, bio-resorbable, bio-degradable and non-allergenic. They have proven safety record in pharmaceutical and biomedical industry for more than 30 years. This rapid-fire session would discuss about the challenges typically encountered during development and manufacture of long acting injectable formulations containing bio-resorbable polymers, such as impact of impurity on drug delivery system and sterilization limitations encountered during use of highly sensitive drugs, including small molecules and large molecules. Audience would be introduced to highly purified and sterile grades of PLA and PLG polymers, their development and scale-up. These grades are designed to overcome some of the challenges encountered during development and manufacture of long acting parenteral products.
Learning Objectives:
Upon completion, participant will be able to learn about challenges during development of long acting parenteral products using bio-resorbable polymers such as impurity and sterilization.
Upon completion, participant will be able to learn about development of highly purified and sterile PLA and PLG polymer to overcome challenges during manufacture of long acting parenteral products.
Upon completion, participant will be able to learn about benefits of using highly purified and sterile bio-resorbable polymers in long acting parenteral products and implants.