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.
“The value of CMC is not measured by the volume of work performed, but by how effectively that work helps a program move forward.”
“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.
PharmaBlock was officially operated in 2008 as a provider of drug-like small molecule building blocks and has since evolved into a fully integrated CRDMO partner following its IPO in 2017 (Stock Code: 300725.SZSE). Today, the company offers end-to-end solutions spanning from early-stage discovery to commercial manufacturing, with expanding capabilities in emerging modalities such as oligonucleotides, peptides, and complex conjugates.
PharmaBlock’s strategy is anchored in advancing sustainability through innovation in green and intelligent chemistry to empower next-generation therapies. In discovery, the company has advanced its building blocks into “PharmaChips” for next generation therapies including novel and high-purity short peptides, amidites and conjugate linkers. Leveraging three distinctive libraries: a DNA-encoded library, a fragment library, and an ultra-large, synthetically accessible virtual library and AI technologies, it enables customers to accelerate hit discovery and lead optimization
In development, drawing on extensive experience in the production of thousands of building blocks, PharmaBlock has built a strong green and intelligent technology platform for both development and manufacturing. This platform includes flow chemistry, process modeling, computational fluid dynamics (CFD), bio-/metal catalysis, high-throughput experimentation (HTE), process analytical technology (PAT), and digitalization, as well as advanced capabilities in Liquid Phase Peptide Synthesis (LPPS). These capabilities allow the company to address complex chemistry challenges, reduce development risks, and minimize environmental impact.
Committed to green and intelligent chemistry, PharmaBlock combines speed with sustainability. Its global “region-for-region” model ensures fast turnaround, reliable supply, and consistent quality for partners worldwide.
