The CRDMO Symeres has announced an expansion to its spray drying capabilities at its Chemistry, Manufacturing and Controls (CMC) development site in Cranbury, New Jersey.
The company announced the initiative to improve formulation development for poorly soluble and challenging small-molecule drug candidates. This capability will support strategies to enhance bioavailability, such as amorphous solid dispersions (ASDs) and solubility optimisation, for compounds from preclinical through Phase II clinical activities.
The investment strengthens Symeres' integrated CMC offering by uniting spray drying, formulation sciences and analytical characterisation within a single development environment.
This allows sponsors to transition from early formulation screening to clinical-ready materials more efficiently, reducing risks, speeding up decision-making and ensuring continuity in development.
Henning Steinhagen, CEO of Symeres, said: "Our investment in spray drying reflects our commitment to supporting customers across the entire drug development journey."
"While Symeres is widely recognised for its discovery expertise, this expanded capability further strengthens our ability to support complex molecules through development and into the clinic."
By combining discovery, development and CMC expertise within one organisation, we can help clients move programmes forward more efficiently and with greater confidence.
The company cited increasing pressure on pharma and biotech companies to accelerate timelines for increasingly complex small molecule candidates, many of which present significant formulation and bioavailability challenges, as the reason for the expansion.
"An increasing proportion of modern small molecule drug candidates require advanced formulation approaches to achieve acceptable bioavailability and clinical performance,” added Paul O'Shea, Managing Director at Exemplify BioPharma, a Symeres company.
By expanding our spray drying capabilities within our integrated Cranbury CMC site, we can help clients address developability challenges earlier, reduce operational complexity and support faster progression into clinical development.
The Cranbury site will now provide laboratory- and pilot-scale spray drying workflows for formulation development, including material screening, process optimisation, and scalable development.
Symeres added that it will be particularly effective for BCS Class II and IV compounds, highly lipophilic molecules and targeted therapies requiring improved oral exposure.
This capability expansion will meet the growing demand from biotech and pharmaceutical companies for integrated partners that support discovery, API development, formulation sciences and analytical activities within a coordinated scientific framework.
By integrating spray drying into its CMC platform, Symeres solidifies its role as a single-source partner for drug substance development, formulation and analytical services, allowing clients to streamline their development processes while maintaining scientific continuity.
"Spray drying programmes require a deep understanding of particle morphology, physical stability, crystallinity, dissolution behaviour and residual solvent control," said O'Shea.
The ability to combine formulation development, analytical characterisation and process expertise within one integrated environment creates a more efficient and agile development model for clients.
"It also enables scientific insights generated during formulation development to be translated more effectively into later-stage development and manufacturing activities.”