Since 1988 High Force Research has worked with organizations operating in practically all end use sectors requiring chemical synthesis input, and offers a range of services allied to new product development
Who we work with Pharmaceutical Biotechnology Diagnostics Imaging Organic Electronics Performance materials Polymers Coatings Fine Chemicals
Who we work with Multinationals SME s Start-ups Spin-outs Virtual Enterprises Universities Charities Institutes
How we can help Chemical R&D - milligram to kilo scale Process Development - route design, development & optimisation - improve yields - reduce the number of steps - reduce batch cycle times - eliminate the use of hazardous materials
How we can help Contract Synthesis - Building blocks & intermediates - Patent analogues - Non-literature targets - Client proprietary compounds - Reference standards - Drug impurity compounds - Metabolites
How we can help Scale-up - gram to kilo Analysis - analytical services and method development Consultancy
How we can help Traceable Manufacture - Pre-clinical studies - API starting materials - Performance materials GMP (MHRA inspected) - Analytical Development - Validation - Stability Studies - Auditing - Reference substances
How we can help The HFR GMP Journey R & D Phase Level Traceable Manufacture Phase GMP Phase Development Traceable Manufacture Preparation Traceable Manufacture GMP Preparation GMP Manufacture Post GMP Manufacture Production method transfer/development Start to prepare the project master file Production reported on BPRs including IPC Conduct a risk assessment Production reported on BPRs including IPC Store in secure qualified and monitored facilities Testing using general methods Develop key analytical methods Test API in full Write the project master file & define GMP start Investigate deviations & out of specifications Despatch by qualified cold chain shipment Formally define key analytical methods Purify a portion of API as a reference std. Create and sign a technical agreement Analysis reported on certificates of analysis ICH stability study Partially validate key tests Characterise and assign purity to reference std. ICH validation of key analytical methods Create TSE statement for API Develop purification methods Take samples for reference markers Preparation of master production records Create campaign report Qualify suppliers/contractors Characterise the reference markers Define remaining analytical tests Create certificate of GMP Compliance Create and sign a technical agreement Start informal stability study Equipment order, log in, PM and PQ Create master production records Raw material order, log in, and analysis
How we can help GMP (MHRA inspected) - During GMP development and manufacture all documents are uploaded in PDF format to a shared file so that the client has complete access to all documentation. This information can be transferred to another manufacturer who can repeat the synthesis on the same scale, and scale-up. - Essentially this package consists of: A. Development reports. B. Analytical development, validation, test methods. C. Stability reports D. Route assignment- document generated prior to GMP, containing basic methodology for each stage including materials, suppliers, raw material specifications, intermediate specification E. A complete set of completed process instructions including access to all historical data/batches manufactured by HFR and including raw data from analysis if required. F. Campaign reports G. Certificates of Analysis
Facilities Operate across 3 sites: Bowburn; Wilton & Alderley Park 1500 m 2 of laboratory space 30+ Fume cupboards 2 x Class 8 clean rooms Jacketed glassware to 30L at -40 to 180 o C Pressure vessels to 7L
Facilities Multinuclear 400Mhz NMR Mass Spectrometry HPLC (UV, DAD) FTIR (ATR) Karl Fischer DSC Classical wet analysis GLC (Liquid and Headspace) Size Exclusion Chromatography Optical rotation
Access to advanced techniques Elemental Analysis XRPD Solid State NMR Raman Spectroscopy Surface Analysis - SEM,TEM, XRF etc. LC-ICP-MS Microbiology
History
Durham
Meet the team CEO Roy Valentine Research Manager Nicola Lembicz Development Manager Barry Thompson Head of Quality Zoe Lilburn Head of Business Development Stella James Operations Director Stuart Penny Research Chemists Development Chemists QA Department QC Department Business Development and Marketing GMP Chemists ~30 staff, one third PhD s Highly experienced team of chemists and analysts
Why choose HFR? For nearly 30 years, HFR has supported the pharmaceutical and chemical industry in their medical and scientific advances Collaborate with companies at the proof of concept stage of their product or technology life cycle Expert in developing and scaling up complex syntheses of molecules used by researchers
Why choose HFR? The only independently owned UK business that works to GMP on small scale production only audited by the MHRA for early stage clinical trials Flexible & adaptable approach to chemical synthesis. Working collaboratively to achieve the highest quality compounds from gram to kilo with products delivered to specification, on-time and safely
Contact us: Head of Business Development Stella James +44 (0) 744 358 7141 stellajames@highforceresearch.com www.highforceresearch.com