Antibody Drug Conjugate (ADC) Development and Manufacturing Challenges and Solutions

In this podcast, we interviewed Dr. J.J. Luo, Executive Director and Dr. Lily Yin, Head of Biologics Conjugation Development, at WuXi Biologics about the state of the ADC marketplace and the challenges in developing antibody drug conjugates. We then dove into reasons behind why they built a dedicated manufacturing facility for ADCs and other bioconjugates and how a single-source development platform can benefit bioconjugate drug development efforts.


Podcast Notes:


I began the podcast by asking Dr. Luo about WuXi Biologics’ investment in and construction of multiple clinical and commercial scale facilities around the world. I pointed out that nearly all of these facilities are dedicated to the GMP production of Drug Substance and Drug Product of antibody or recombinant protein therapeutics, but their new facility appears to be dedicated for a very specific niche within the biologics industry. JJ explained that the new facility was purpose-built for the manufacture of a wide range of bioconjugates, in which the largest class of these products would be Antibody Drug Conjugates. He went on to say that this new facility is part of WuXi Biologics’ new state-of-the-art integrated Biologics Conjugation Solution Center in Wuxi City, China. The center will consolidate all bioconjugate drug development and commercial manufacturing of bioconjugates in the future.


I followed up by asking JJ about the drivers behind building a facility dedicated solely to ADCs and other bioconjugates. He stated that although bioconjugates are a subset of the greater biological therapeutic marketplace, various market research reports have shown a year on year increase in the number of ADCs and other bioconjugates entering clinical trials over the past 5 years by roughly 12% per year worldwide. Some estimate that commercial sales of ADCs will grow 22% annually for the next 5 to 10 years. In addition, based on drug company pipeline data, it appears that this trend will continue into the foreseeable future. JJ made it clear that WuXi Biologics’ mission is to provide open access drug development platforms to ensure that every drug can be made and every disease can be treated. Given WuXi Biologics’ expertise, vast capabilities, and resources they believe that they can provide a single-source product development and supply chain for companies developing these novel therapeutics.


Dr. Yin added that WuXi Biologics has a strong history of providing extensive product development and manufacturing services to clients. They have developed a wide variety of bioconjugates from idea to GMP manufacturing for clinical study. She goes on to share that they have provided full CMC services for 11 IND filings for bioconjugate products in just the last few years and 25% of the total IND filings for ADCs in 2018. With the new bioconjugation facility, WuXi Biologics’ has increased GMP manufacturing capacity for both drug substance and drug product and can meet their client’s needs for clinical supply while still offering additional capacity for new clients.


Next, I asked Dr. Yin about their ability to provide a single-source for all bioconjugate needs. I clarified that ADCs and other bioconjugates are complex molecules with both chemical and biological components. I wanted to know how they would be able to provide all the services required to get from early discovery to clinical supply and if there were any gaps. Lily said that WuXi Biologics is known for their ability to take clients from early discovery and lead generation of antibody therapeutics into development and the clinic. Through WuXi Biologics’ expertise and single-source services they are able to provide this without having to use another service vendor. She went on to say WuXi Biologics is now a separate company, but it is still a member of the WuXi AppTec Group of companies. They still work very closely with the Group and utilize its vast resources a...