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Innovative approaches in the formulation of biologics will be shared in this session. Topics covered will include exploring the strategies in the development of formulations to support co-formulation of drug products and different routes of administration. The use of nanoparticles in the development and delivery of mRNA therapeutics as well as the use of application of novel freezing and drying technique will be explored. The session will also include an interactive panel discussion following the presentations.
Drug delivery technologies are evolving to support the delivery of drugs that balance enhanced safety and efficacy profiles with ease of use. With rapid evolution comes challenges to implementation of new devices and technologies…
In-depth analytical characterization of biological drugs and vaccines is important to aid in their development, and innovation in analytical technologies is crucial for the advancement of complex modalities…
With the endorsement from ICH Management Committee in 2018 to introduce a new quality guideline for Analytical Development (ICH Q14) and a complementary revision of ICH Q2(R1) for Validation of Analytical Procedures, product owners will gain further guidance on enhanced approaches to analytical met…