Process Research & Development

Safe, economical & compliant processes to produce high-purity drug substances.
Scale complex APIs from grams to multi-kilograms
Our PR&D capabilities cover every stage of route and process development–from early evaluation to demonstration scale.

A closer look at our suite of process development capabilities and equipment:

This comprehensive approach ensures robust, scalable processes that support rapid progression from lab to clinic:

  • 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 offer hazard assessments and PMI/nitrosamine evaluations, all conducted under full regulatory compliance. This includes licensing for the use, synthesis, and supply of controlled substances (Schedules 1–4).
 



 



We are equipped for flexibility, precision, and scale-up with equipment including:
 

  • Glass and PTFE jacketed 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 with a variety of detection capabilities
  • Karl Fischer moisture determination
  • Biotage Selekt chromatography system

Arcinova: Your partner in PR&D

Expedited route selection to optimise scale-up

Combining rapid route selection with innovative technologies, we define the most efficient, robust and scalable pathway to your drug substance. We apply tools like Design of Experiments (DoE), parallel reactor screening and computational modelling where appropriate, to generate data early and save months in development.

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 characterised 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 plays a vital role in rapidly identifying the optimal salt form and polymorphic landscape of your API, while 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, specialising 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 minimise risk and speed-up the delivery of complex drug development programmes so you can move confidently from lab to clinic. 

Image
arcinovaPRD
Contact Us
Discuss your next drug programme with us today.