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Innovative approaches in the delivery of biologics will be shared in this session. Topics covered will include the use of exosomes in the delivery of oligonucleotides as well as the combination of device technology with oral delivery of biologics. Insights into the use of a Proteo-Lipid Vehicle platform for the delivery of therapeutics will also be shared. First genetic medicines platform to enable highly targeted delivery to organs, tissues and cells beyond the liver will be discussed. The session will also include an interactive panel discussion following the presentations.
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…
The morning session will focus on comparability for novel protein-based modalities. The afternoon session will focus on comparability for mRNA vaccines and microbiome products…
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…