The Arcinova Advantage: Built for Early Development Success
Integrated expertise in solid-state science, process development and GMP drug substance manufacturing to help advance molecules into the clinic.
Reduce Development Risk
40+ years of integrated solid-state expertise helping minimise late-stage surprises.
Accelerate First-in-Human Studies
Fit-for-purpose GMP drug substance supply designed for rapid clinical advancement.
Regulatory Confidence
Submission-ready CMC documentation developed alongside process development.
Proven Quality
20+ years of successful regulatory inspections with no critical observations.
Integrated PR&D, solid-state, and GMP teams under one roof
Robust CMC datasets for global regulatory submissions
Flexible GMP manufacture of early phase API
(up to 10 kg)
Licensed manufacture and supply of controlled substances (Schedule 1–4)
Integrated Drug Substance Expertise
Scalable API Development and GMP Manufacturing
Advanced technologies and integrated PR&D and manufacturing expertise supporting scalable API development from early-stage synthesis through GMP production.
Analytical Development, Quality Control and CMC Support
Phase-appropriate analytical methods, quality control strategies and CMC support developed alongside manufacturing activities.
Complex API Manufacturing and Scale-Up
Experience across complex chemistries, controlled substances and potent APIs, supporting safe and efficient scale-up.
Integrated Process Development and Solid-State Expertise
Analytical, process development and solid-state specialists working together to optimise manufacturability and reduce development risk.
Data-Driven Process Optimisation
Data-led process development using advanced experimentation and modelling approaches to improve efficiency and accelerate timelines.
GMP Drug Substance and API Manufacturing Facility in Alnwick, UK
Significant investments have been made to expand our Alnwick, UK facility over the past few years, enabling both batch and continuous flow manufacturing and Annex-1 compliance for aseptic manufacturing.
Our expanded space features multi-purpose capacity of up to 14 GMP reactor streams with volumes ranging from 5 to 150 L and deployment of both batch or continuous flow chemistry technologies. This allows us to flexibly manufacture GMP API batches at the quantities you need for your early stage drug programmes.
Our industry 4.0-ready, GMP drug substance facility is also equipped with CFR21-compliant data handling and real-time process control, facilitating advanced multivariate analysis to ensure the highest standards of quality and regulatory compliance at every stage of production.
End-to-End Drug Substance Development & Manufacturing
Integrated process development, solid-state expertise, GMP API manufacturing and CMC support for first-in-human programmes.
- Process Development & Scale-Up
- Solid-State & Preformulation Expertise
- GMP API Manufacturing
- Regulatory-Ready CMC Support
40+ Years
Drug substance development and manufacturing experience
20+ Years
Successful regulatory inspections with no critical observations
14 GMP Reactor Streams
Supporting flexible API scale-up and manufacturing
Schedule 1-4
Licensed manufacture and supply of controlled substances