A closer look at our suite of process development capabilities and equipment:
Our PR&D capabilities cover every stage of route and process development–from early evaluation to demonstration scale:
- Route selection and optimisation
- Experimental design (DoE)
- PAT reaction monitoring
- Impurity synthesis and characterisation
- Isolation and crystallisation modelling
- Definition of critical process parameters (CPPs)
We also provide hazard assessment, PMI/nitrosamine evaluation, and integrated support from our analytical and solid-state chemistry teams. All work is carried out under full regulatory compliance, including licensing for the use, synthesis and supply of controlled substances (Schedule 1–4).
We are equipped for flexibility, precision, and scale-up with equipment including:
- Glass and PTFE reactors – 2 L, 5 L and 20 L
- EasyMax reactors
- HF-calorimetry with off-gas measurement
- ReactIR for real-time in-process monitoring HPLC/UHPLC
- Karl Fischer titration
- Biotage Selekt chromatography system
Arcinova: Your partner in PR&D
Expedited route selection to optimise scale-up
Expert analytical support to manage impurities and deliver high-quality API
Our chemists work closely with our analytical development and quality control teams from the outset. Using an integrated, team-based approach and a wide range of open-access and specialist platforms, we generate robust data quickly and efficiently—ensuring impurities are clearly defined and characterized early, effective control strategies are in place, and high-quality API is delivered reliably and within specification.
Integrated solid-state support to optimise API isolation and yield
Our solid-state sciences team is crucial in swiftly identifying the optimal salt form and polymorphic landscape of your API, establishing key physical properties like stability and solubility. By integrating this expertise early in development, we accelerate isolation and purification strategies, enhancing yield, throughput, and purity to ensure a more efficient and reliable manufacturing process.
Accelerate your molecule's journey from candidate selection to first-in-human trials with Arcinova.
Arcinova fast-track your molecule from candidate selection to clinic with integrated expertise in drug substance process development, scale-up, and manufacturing.
We act as an IND/IMPD launchpad, specializing in progressing molecules from preclinical candidate selection to GMP manufacture for first-in-human trials.
We holistically consider the synthetic route, molecular properties and regulatory strategy to minimize risk and speed-up the delivery of complex drug development programs so you can move confidently from lab to clinic.
