Outsourcing-Pharma (OSP) recently spoke with Youchu Wang (YW), vice president of process R&D with contract development and manufacturing organization (CDMO) WuXi STA about climbing demand for high-potency active pharmaceutical ingredients (HPAPIs), how his organization is expanding to meet the demand and specialized service and expertise the company offers.
OSP: Could you please tell me about WuXi STA—who you are, what you do, your key capabilities and specialties, and what sets you apart from the competition.
YW: STA Pharmaceutical (WuXi STA) - a subsidiary of WuXi AppTec - is a leading contract development and manufacturing organisation (CDMO) serving the global life sciences industry, with five development and manufacturing sites operating in China and the US. We safely and securely develop and manufacture chemically synthesized molecular modalities, including small molecules, peptides, oligonucleotides, as well as highly-potent toxins and toxin-linkers for antibody-drug conjugates (ADCs).
We provide our more than 420 pharma and biotech customers a truly integrated chemistry manufacturing and control (CMC) platform – offering drug substance, drug product, analytical, and regulatory filing support – from the preclinical stage to commercial use.
OSP: Could you please share your perspective on the HPAPI market—how it’s grown, shifting demand, production centers, etc.
YW: The last few years have been extremely buoyant for the HPAPI market, with a robust growth rate of 8.5% compound annual growth rate (CAGR) and estimated to reach $28bn by 2024. Demand in the last decade has been driven by the rise of oncology targets and new hyper-targeted therapies, such as ADCs.
Since we opened our first HPAPI facility in 2014, we’ve seen a steady increase in HPAPI demand, which prompted us to continue expanding our capacities both in process R&D and manufacturing.
OSP: Please tell me all about your new HPAPI facility.
YW: Our newest facilities, located in Shanghai Jinshan and Changzhou, China, are a result of the HPAPI demand we have seen in recent years. WuXi STA can handle HPAPI with an occupational exposure limit (OEL) as low as 10 ng/m3 for all common reactions at these drug substance sites.
Between the two new sites, we now have more than 10 HP reactors ranging from 1L to 1,000L, as well as the necessary ancillary production equipment and analytical equipment.
At these sites, we can provide customer a truly integrated process across R&D and manufacturing capabilities, along with in-house analytical support. This also enables our cross-functional teams to quickly collaborate and overcome any potential challenges that may arise during development.
Quality standards are vital component of an HPAPI facility, and I am proud to note that both of these WuXi STA sites have successfully passed multiple inspections from the US Food and Drug Administration (FDA) and the China National Medical Products Administration (NMPA), as well as inspections from other major regulatory agencies, meeting the highest quality and environment, health and safety (EHS) standards.
OSP: Please tell me about the experts you’ve got on hand—you mention they’re versed in ADC payloads, toxin linkers, HPAPI and other areas.
YW: For ADC programs, we’ve manufactured the common payloads such as MMAE/F, DM1/DM4, Calicheamicin, Duocarmycin, Doxorubicin, SN-38, and PBD. But we are best known for our extensive experience and strong track record in supporting the process development and manufacturing of novel payloads for our customers across clinical stages. Our experience with manufacturing a variety of common and custom linkers and payloads provides our customers with great flexibility for a combination of these options.
Specifically, the Changzhou site houses our oligonucleotides and peptides platforms in addition to HPAPI; this allows us to develop and manufacture novel payloads and conjugation modalities that include oligonucleotide- or peptide-based linker-payloads, all within one site providing efficiencies across CMC platform. Efficiencies include in-parallel activities, providing expedited sample transport, and information sharing across project teams, as well as efficient trouble-shooting, to shorten the overall project timeline.
OSP: Can you tell how you package integrated services ADCs?
YW: We offer an end-to-end platform for ADCs – including mAb, payload, toxin-linkers and conjugation for innovators – from discovery and development to commercial production.
Since 2018, WuXi STA has collaborated with more than two dozen partners on over 80 ADC projects. We currently have nearly 30 ongoing projects, including 2 in late phases, supported by a team of approximately 100 scientists. We look forward to helping our customers meet the increasing demand for ground-breaking advancements in ADCs and other healthcare solutions.