In this presentation at the 2022 Nelson Labs Virtual Symposium, Dr. Mahler will provide a comprehensive overview of biologics product development, focusing specifically on the selection and qualification of primary packaging for parenteral biologics drug products.
The development of biologics presents unique challenges, particularly in ensuring that the primary packaging is suitable for maintaining the stability, efficacy, and safety of the drug product. Dr. Mahler will discuss the critical factors involved in choosing appropriate primary packaging materials, including compatibility with the biologic formulation, protection from environmental factors, and compliance with regulatory standards.
Attendees will gain insights into the processes and criteria used to evaluate and qualify primary packaging for parenteral biologics. This includes an examination of the testing methodologies employed to ensure that the packaging does not interact negatively with the biologic drug product, thereby preserving its integrity and therapeutic effectiveness.
Dr. Mahler will also highlight best practices and recent advancements in primary packaging technologies that are tailored to meet the specific needs of biologics. By understanding these considerations, participants will be better equipped to make informed decisions about packaging materials and strategies that enhance the development and commercialization of biologic products.
This presentation is essential for professionals involved in the development, manufacturing, and regulatory compliance of biologics. By attending, participants will acquire valuable knowledge on the critical aspects of primary packaging selection and qualification, ensuring their biologic products are safe, effective, and compliant with regulatory requirements.