BioPhorum has announced the formation of the Synthetic Molecule Process Innovation Phorum, uniting an ecosystem of 20 leading organizations to urgently address the rapidly accelerating pace of innovation in the small molecule sector.
This new initiative represents a significant portion of the small molecule supply chain, bringing together global pharmaceutical companies, including AstraZeneca, GSK, Merck, Merck & Co Inc. Rahway, N.J. USA, Roche, Takeda, and Eli Lilly, alongside specialist contract development and manufacturing organizations (CDMOs), technology partners and regulatory authorities.
The UK's Medicines and Healthcare products Regulatory Agency (MHRA), the British Pharmacopoeia, and the US Pharmacopeia are actively participating to help accelerate harmonized industry change. A core purpose of this new Phorum is to serve as the critical interface between the industry and these regulators to create global acceptance of change for new ways of working.
The synthetic molecule sector is experiencing a powerful renaissance, driven by breakthroughs in precision oncology, neurology, and next-generation oral therapies. As pipelines shift from niche, high-potency compounds to high-volume global treatments, the industry faces an urgent need to adopt advanced, agile manufacturing technologies. Accelerating this innovation requires seamless collaboration across the ecosystem to ensure facilities can efficiently scale up, scale out, and secure global supply chains for the next generation of patient care.
“As pipelines fill with complex small molecules, from next‑generation obesity treatments to breakthrough therapies in oncology and immunology, the question is no longer whether science can deliver, but whether manufacturing can keep up,” said Andrea Johnston, Senior Phorum Director at BioPhorum.
“By bringing global pharma and specialist CDMOs around one table, the BioPhorum Synthetic Molecule Process Innovation is designed to turn market momentum into robust, efficient, and sustainable ways of making these products at scale.”
To define the initial program for this launch, the Phorum leadership team recently convened for a two-day event in Cork, Ireland. Through a series of collaborative workshops, four primary focus areas for initial workstreams were established:
- Peptide manufacture: Increasing manufacturing capacity and addressing challenges with raw materials.
- Regulatory alignment: Driving global regulatory alignment required for the acceptance of solvent reuse, and CMC guidance for synthetic peptide manufacturing under BLA.
- Model based predictive control (MBPC): Developing frameworks for end-to-end (E2E) robust control strategies.
- Knowledge lifecycle management: Developing a common language and standardized approaches to data sharing across the product lifecycle.
The launch of the BioPhorum Synthetic Molecule Process Innovation forms part of BioPhorum's broader growth journey, which includes diversifying into aligned products and markets across the pharmaceutical space. Over the past 18 months, BioPhorum has expanded its global portfolio by acquiring specialist training companies Brookwood Global, Compliance Hub and Inspired Pharma.
The company has also introduced an Implementation Services offering for members, strengthened by the acquisition of PharmaX Solutions, an organization specializing in manufacturing digital transformation.
Collectively, these enable BioPhorum to support member companies and the wider industry in driving efficiency and improvement based on the collaboration’s best practice guidance.
“This expansion in both our footprint and influence enables us to serve our members and the wider industry to an even greater effect," said Deborah Kobewka, CEO of BioPhorum. "Diversifying our offerings to meet the most urgent challenges of the sector continues to be a key strategic focus for us in 2026.”
For further information about the BioPhorum Synthetic Molecule Process Innovation collaboration, please visit the BioPhorum website here: https://www.biophorum.com/phorum/biophorum-synthetic-molecule-process-innovation/
BioPhorum is a global industry organization that provides a forum for senior biopharmaceutical leaders to collaborate and accelerate progress for the benefit of all. It focuses on developing best practices and technology roadmaps in drug substance, fill finish, process development, and manufacturing IT.
