Challenges and Successes in Externalization of the ADC Supply Chain

Sourcing for the manufacture and control of Antibody-Drug Conjugates (ADCs) used in clinical trials requires strategic planning, establishment of a specialized support network, and execution of several interdependent tasks.  ADCs are complex molecules, a fusion of a biological, the monoclonal antibody (mAb), and of small molecules, the linker and the toxic payload.  Facilities of acceptable standards for the handling of high potency materials need to be engaged, and there is a limited supply currently.  This is further complicated by the fact that there is not one contract facility that has fully integrated services, a “one-stop shop” capable of mAb production, linker and/or payload synthesis, conjugation of mAb to linker-payload to make the Drug Substance, and finally, formulation of the ADC to make the Drug Product.  Strategizing the best outsourcing practices for producing and testing ADCs, and establishing guiding principles for externalization to ensure the selection of the right CMOs for ADC outsourcing and technology transfer, will be further discussed.
 
Presentation by Firelli Alonso, Ph.D.

Dr. Firelli Alonso is Senior Director, External Supply at Pfizer, Inc.  She heads the BioTherapeutics and Vaccines Outsourcing group in Worldwide Research and Development.  Fi has more than 31 years of combined experience in research, development, and cGMP production of biological products and vaccines, and more than 11 years of experience in outsourcing, project / contract management, and technology transfer to qualified third parties.  Her areas of expertise include viral vectors and vaccine development, biotherapeutics and vaccine process development and cGMP production, project management, technology transfer, outsourcing, and budgets and operations.

Presented by Jyothi N. Swamy, Ph.D.
Dr. Swamy has been in the pharmaceutical business for over 25 years covering areas ranging from analytical method development, method validation, cleaning validation and stability.  Jyothi has been with MilliporeSigma for 11 years in various roles, including Sr. Chemist, Quality Control Supervisor and Sr. Project Manager.  Jyothi is currently part of Global Project Management team for MilliporeSigma, where she is responsible for multi-site custom products with focus on antibody drug conjugate projects.  Jyothi was an integral part of SAFC and Baxter collaboration working out the process integration with Baxter’s counterparts.  She received her B.S. and M.S. at Bangalore University, India, M.S. at Indian Institute of Science, India, her Ph.D. in Synthetic Organic Chemistry at University of Missouri, St. Louis.  
 
Presentation Title: MANAGING COMPLEX ADC PROJECTS IN A GLOBAL ENVIRONMENT
Finding a contract manufacturing partner for the development and commercialization of key intermediates, complex small-molecule APIs and biologic drug substances shouldn’t be such a headache. The uniqueness, versatility, and complexity involved in each project only means you need to make sure you’re asking the right questions before putting your trust in a CMO.  A transparent supply chain is only part of the solution. You’ll need a partner that has an in-depth understanding of the project needs and global project management expertise. Join Jyothi Swamy as she covers all the critical components required for a mutually beneficial partnership that paves the way for a high quality, streamlined, comprehensive, and collaborative solution for the production of ADCs—from development of conjugate, linkers, payloads, drug product fill finish from clinical supplies to commercial drug product.