Dear Valuable Partners and Friends,
As we close out the year and the events of our ever-changing world swirl around us, I am constantly reminded through my conversations with you, why I am so proud to be part of an industry dedicated to making positive changes in the daily lives of so many. One particular instance was the recent approval by the FDA and the European Commission of Pombiliti™, a biologic developed by our long-time client and partner, Amicus Therapeutics, that brings relief to those suffering from late-onset Pompe’s disease.
The journey to achieve this milestone by Amicus started when they entrusted us in 2012 to help them develop this exciting novel biotherapeutic from the initial concept stage to commercialization. Enabled by our proprietary one-stop integrated technology platforms and unparalleled GMP manufacturing capacities we overcame the technical and bioprocessing challenges to keep them on their requested timelines and today we are their commercial drug substance manufacturing partner and key commercial drug product supplier at five facilities across our global manufacturing network in China, Ireland and Germany.
This story is but one of the 20+ client stories and associated biologics that in the past few years we have helped bring to the market for the benefit of patients worldwide. Many of these products, first given to us in early R&D, and under strict expedited timelines, we now manufacture in one of our 23 different drug substance or drug product GMP facilities. Our commitment to drive innovation for our clients at the earliest stages of biologics development pertain to both small, venture-backed entities as well as large pharma.
Our unique CRDMO model brings us exciting developments in R, D and M in 2023. In R, we licensed our potential best-in-class CD3 platform to GSK and will enable them to develop four novel CD3-bispecifics for more than USD $1billion potential payment. In D, we enabled 122 INDs for global clients in 2022 including an RNA-based IND. As a result, we have brought 465+ different molecules to the clinic including 100+ ADCs and 100+ bispecific antibodies. We have expanded capacity to be able to bring 150 molecules to the clinic per year. Our Cranbury, NJ clinical manufacturing facility is ready to take on DNA to IND projects and finished all batches in 2023 with a 100% success rate. In M, we have 23 manufacturing projects ongoing and just signed our 1st microbial-based commercial manufacturing project. We have developed capacity to run 16 DS and 12 DP PPQs each year. Our Ireland facility started its 1st PPQ in Q4 2023 with 5 more planned in 2024. We have completed about 30 DS and DP PPQs each with a 95+% success rate. The demonstration of our quality is most apparent in the fact we have passed 31 regulatory agency inspections in the last couple of years. Most notably we have no data integrity related findings. With over 2,500 drug substance batches and 1,700 drug product lots manufactured at 98% and 99% success rate respectively, it is clear our commitment to quality has penetrated across all levels and sites in our global footprint. These remarkable efforts and achievements give me faith that we, along with all of you, can one day achieve our company’s vision that “every drug can be made and every disease can be treated.”