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.
CED Life ScienceThe CED Life Science Conference will be attended by Masha Kononov, Senior Director Emerging Pharma US and Gail Frey, Senior Director Key Accounts US.
CED Life ScienceDates: 26th - 27th FebruaryLocation: Raleigh, NC
Drug Delivery & Formulation SummitThe DDF Summit 2019 will be attended by Dr. Nathalie Huther, Business Development Manager Europe.
Drug Delivery & Formulation SummitDates: 11th - 13th MarchLocation: Berlin, Germany
BioEurope SpringBioEurope Spring will be attended by Dr. Nathalie Huther, Business Development Manager Europe.
BioEurope SpringDates: 25th - 27th MarchLocation: Vienna, Austria
Regulatory & Consultancy
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
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
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
- 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
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
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.