Nanjing – November 09, 2026 -- PharmaBlock hosted a two-day CMC Lifecycle Strategy Forum in Nanjing on November 5 and 6, gathering experts with senior R&D experience at AstraZeneca, AbbVie, Bayer and Pfizer to debate how stage-appropriate chemistry, manufacturing and controls (CMC) decisions can improve development efficiency.
Professionals from Seda Pharmaceutical, Jacobio Pharma, Benemae and PharmaBlock also took part. The agenda covered candidate developability, solid-state science, model-informed drug development, clinical supply and commercial manufacturing.
Out-licensing push raises the bar on process and quality readiness
As China-based biotechs accelerate global development through out-licensing and international partnerships, prospective partners are weighing more than scientific differentiation and clinical potential. Developability, process and quality readiness, clinical supply and commercial preparedness increasingly determine whether a program can move reliably through clinical development, partnership and commercialization.
Speakers reject moving all late-stage work to the front of a program
Earlier CMC involvement should not mean pulling every late-stage activity forward, participants said. Teams should instead identify the questions and risks critical to the current stage while tracking future clinical, regulatory and commercial requirements.
Early priorities include candidate developability, API properties, solid form, formulation performance, drug exposure and fit-for-purpose clinical supply. Later stages shift toward process and product understanding, analytical and control strategies, technology transfer, validation, batch consistency and commercial supply.
Speakers also examined how chemical route and process choices affect timelines, scale-up, manufacturing economics and future supply. Model-informed drug development sessions linked API properties, formulation performance, pharmacokinetics and exposure-response relationships to dose selection and product decisions.
Panel ties CMC choices to due diligence and partnership readiness
A panel applied these principles to candidate selection, formulation, process optimization, clinical supply, due diligence and partnership readiness. Yaohui Ji, Senior Vice President and Head of CDMO Business at PharmaBlock, said a development partner must understand where a program stands and what its next milestone requires.
Before the forum, participants toured the PharmaBlock Research Institute and PharmaBlock OPC R&D Center in Nanjing. The visits covered continuous flow chemistry, high-throughput experimentation and process analytical technologies, plus development capabilities for oligonucleotides, peptides and conjugates.