Agile Research & Development

Efficient, end to end solutions

Arcinova is a Contract Research and Development Organisation operating from a 15,000m2 facility which has benefited from more than 36 years of investment as a key research and development centre for Sanofi and Covance. 

We work to enhance the health and wellbeing of society by helping companies to develop life changing medicines and take them to market quickly, effectively and efficiently. 

Our focus is on API process research, the development, validation and application of analytical, microbiological and materials science spectroscopic methodologies, scale-up and early phase clinical product manufacturing. We also provide non-clinical and clinical 14C, API, drug product, bioanalysis, regulatory and consulting services.

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Isotopic Labelling

Carbon-14 and stable isotope labelling to support clinical mass balance, ADME and bioanalytical studies; GMP compliant and non-GMP synthesis.

  • Radiolabelled [14C] and stable labelled synthesis
  • Ability to safely handle high potency / high hazard compounds (cytotoxics)
  • Synthesis of metabolites & reference materials aiding Bioanalytical and Metabolism studies
  • Degradants and process impurities to support API development

Drug Substance

Innovation for the secure delivery of drug substance development, scale up and manufacturing services.

  • Full synthesis of drug substance and support services
  • One stop development and kilo scale manufacturing facility from grams to multi tonnes
  • Strong route selection, process development and impurity tracking expertise
  • Kilolab / Pilot Plant Manufacture
  • Operate both Process R&D (PR&D) and API Scale-up manufacturing laboratories
  • Continuous manufacturing facility

Formulation Development

Operate both Process R&D (PR&D) and API Scale-up manufacturing laboratories

  • Application of specialist spectroscopic knowledge, including the use of in-house NMR equipment, to challenging drug development issues and impurity / metabolite identification studies
  • Molecule development

Drug Product

  • The development of a range of non-clinical and clinical formulation types, including 14C labelled materials, supported by materials science expertise
  • The manufacture of both oral and intravenous IMPs for early clinical phases
  • Includes 14C labelled products
  • Includes high potency/high hazard materials
  • The distribution of clinical product across the world using a controlled chain of custody
  • The provision of drug development advice

Bioanalytical Services

Our experienced team will deliver flexible solutions to meet your bioanalytical needs

  • State of the art ICP-MS and LCP-ICP-MS instrumentation, operating in GLP or GCP environments
  • Experienced in the development, validation, application and technology transfer of LC, UPLC, GC and ion chromatography based assays
  • GC-MS, LC-MS/MS and UPLC-MS/MS assays
  • In vitro assays and bespoke biochemical assays
  • Metabolite identification studies

Analytical Services

We have the capability, experience and equipment to create robust analytical and microbial techniques to support your project, from early development phase to GMP product release

  • The development, validation and documentation of a range of chromatographic and non-chromatographic test methodologies
  • The application of test methodologies in a GMP environment for the purposes of stability testing and quality control
  • The development, validation and documentation of microbiological test methodologies
  • In house, ICH compliant, stability test rooms and photostability testing equipment

Regulatory & Consultancy

Established approaches for successful compilation and integration of CMC dossier Sections, in conjunction with fully interactive technical support, facilitates submissions to all principal regulatory authorities

  • Potential Mutagenic Impurity (GTI) Assessments
  • CMC Dossiers

Facilities and Warehouse

Situated in Alnwick, UK, on a 34-acre site, Arcinova’s 15,000m2 facility has benefited from decades of investment as a key research and development centre for a global pharmaceutical company. This allows us to offer a rare range of on-site capabilities as a CRDO and we have the scope and quality of equipment to support you through pre-clinical development.

Offices, Archiving and Conference Centre

Arcinova can offer document/specimen storage solutions in our purpose-built, regulatory compliant Archive. The key features are:

  • 214 m2 facility
  • 2.4 km high density rolling shelving
  • Monitoring of environmental conditions
  • Fire safety integral to design

Technology, Development and Scale-up

Arcinova is investing in transformational technology using synthetic biology, continuous processing and high potency containment to provide highly productive scale-up capacity.

Latest News

  • Arcinova's Chief Scientific Consultant Wins 2019 Cope & Cope Scholar Award


    Dr. Aggarwal is currently working as a Chemistry Professor at the University of Bristol however, Dr. Aggarwal also works with Arcinova ...

  • Arcinova awarded £1 million government grant to revolutionise digital medicines manufacturing


    Arcinova, a multi-service Contract Research and Development Organisation (CRDO), has been awarded a £1 million government grant for its £2 million Fill-Inova Project. ...