PharmaBlock Convenes Global CMC Experts to Advance Smarter Drug Development Decisions

PharmaBlock hosted its CMC Lifecycle Strategy Forum in Nanjing on November 5 and 6, bringing together experienced pharmaceutical development leaders and technical experts to explore how smarter, stage-appropriate CMC decisions can improve development efficiency and program readiness.

As China-based biotech companies accelerate global development through out-licensing and international partnerships, prospective partners are looking beyond scientific differentiation and clinical potential. Developability, process and quality readiness, clinical supply, and commercial preparedness are becoming increasingly important in determining whether a promising program can progress reliably through clinical development, partnership, and commercialization.

The forum brought together experts with senior R&D experience at AstraZeneca, AbbVie, Bayer, and Pfizer, alongside professionals from Seda Pharmaceutical, Jacobio Pharma, Benemae, and PharmaBlock. Discussions covered candidate developability, chemical and drug product development, solid-state science, model-informed drug development, clinical supply, phase-appropriate CMC strategies, and commercial manufacturing.

“A development partner needs to understand where a program stands, what the next milestone requires, and how the right expertise and evidence can be brought together to support progress,” said Yaohui Ji, Senior Vice President and Head of CDMO Business at PharmaBlock.

Stage-appropriate development, not simply more development

A recurring theme throughout the forum was that earlier CMC involvement should not mean moving every late-stage activity to the front of a program. Instead, teams should identify the questions and risks that are critical to the current development stage while maintaining a clear view of future clinical, regulatory, and commercial requirements.

In early development, priorities may include candidate developability, API properties, solid form, formulation performance, drug exposure, and fit-for-purpose clinical supply. As programs advance, the focus progressively shifts toward deeper process and product understanding, analytical and control strategies, technology transfer, validation, batch consistency, and reliable commercial supply.

Speakers also examined how chemical route and process decisions can affect development timelines, scale-up, manufacturing economics, and future supply. Discussions on model-informed drug development demonstrated how API properties, formulation performance, pharmacokinetics, and exposure-response relationships can be connected to support dose selection and product development decisions.

Connecting expertise across the development lifecycle

A panel discussion translated these principles into practical development and partnership scenarios, including candidate selection, formulation, drug exposure, process optimization, clinical supply, due diligence, and partnership readiness.

Ahead of the forum, participants visited the PharmaBlock Research Institute and PharmaBlock OPC R&D Center in Nanjing. The visits highlighted PharmaBlock’s work in continuous flow chemistry, high-throughput experimentation, and process analytical technologies, as well as development capabilities for oligonucleotides, peptides, and conjugates.

As an integrated CRDMO partner supporting programs from early discovery through commercial manufacturing, PharmaBlock brings together expertise across discovery chemistry, process development, solid-state science, drug product development, analytical development, and manufacturing.

Through the CMC Lifecycle Strategy Forum, PharmaBlock aims to connect global drug development experience with China’s innovation ecosystem and help biotech companies generate the right evidence at the right time as programs advance toward clinical milestones, global partnerships, and commercialization.