Symeres, a leading contract research, development, and manufacturing organisation (CRDMO), has expanded its spray drying capabilities at its Cranbury, New Jersey, Chemistry, Manufacturing and Controls (CMC) development site to support formulation development for poorly soluble and development-challenged small molecule drug candidates.
The expanded capability is designed to support bioavailability enhancement strategies, including amorphous solid dispersions (ASDs), particle engineering and solubility optimisation for compounds progressing from preclinical development through Phase II clinical activities.
The investment strengthens Symeres’ integrated CMC offering by combining spray drying, formulation sciences, analytical characterisation, solid-state sciences and process development within a single development environment. This enables sponsors to progress from early formulation screening through to clinical-ready material within one coordinated scientific framework, reducing tech-transfer risk, accelerating decision-making and improving development continuity.
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 expansion comes as pharmaceutical and biotech companies face increasing pressure to accelerate timelines for increasingly complex small molecule candidates, many of which present significant formulation and bioavailability challenges.
“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 now supports laboratory-scale and pilot-scale spray drying workflows for a range of formulation development activities, including rapid material screening, process optimisation and scalable process development. The platform is particularly suited to Biopharmaceutical Classification System (BCS) Class II and IV compounds, highly lipophilic molecules and targeted therapies requiring enhanced oral exposure.
The capability expansion reflects growing demand from biotech and pharmaceutical companies for integrated development partners that can support discovery, API development, formulation sciences and analytical activities through a coordinated scientific framework.
By integrating spray drying within its broader CMC platform, Symeres further strengthens its position as a single-source partner for drug substance development, formulation and analytical development, enabling technologies and clinical-phase manufacturing. The unified approach helps clients streamline development activities while maintaining scientific continuity across programmes.
“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.”
Symeres has already seen strong interest from clients seeking enabling formulation solutions for poorly soluble compounds and development programmes where bioavailability limitations could otherwise delay clinical progression.
The spray drying investment aligns with broader industry trends toward increasingly complex molecular modalities, compressed development timelines and greater reliance on strategic outsourcing partnerships among emerging biotech companies.
