Process R&D laboratory
at Alderley Park, Manchester, UK
Sai Life Sciences' Process R&D laboratory at Alderley Park, Manchester, UK serves as a centre of excellence for Process and Analytical Development to the expanding list of global clients, adding value to their NCE small molecule development programs.
Sai Life Sciences’ lab in Alderley Park serves as a vital bridge, enabling seamless integration with the rest of the company’s service offerings across the US and India, spanning the drug discovery and development continuum including Biology, Medicinal Chemistry, DMPK, and Toxicology through to commercial scale manufacturing.
Our Services at Manchester
- Route Scouting
- Early and Late-Phase Process Development
- Control Strategy Definition
- Analytical Method Development
- GLP-Tox Material Preparation
- GMP Phase 1 and 2 clinical API manufacture
- Tech Transfer support for larger scale manufacture in India
- ICH M7 & CMC Regulatory Consultancy
UK Leadership Team
Instruments and Capabilities
- Buchi Versoclave and Large Scale Kiloclave Pressure Vessel Systems: Extremely versatile systems with interchangeable vessels from 1L to 20L. Enables process development and production with enhanced data logging for subsequent technical transfer to manufacturing plant.
- Radleys Mya 4 Reaction Station: A 4-zone reaction station offering safe and precise heating, active cooling, software control and data-logging for 24/7 unattended chemistry.
- Radleys Reactor-Ready™ Lab Reactor: Reactor-Ready is designed as a universal reactor workstation with a range of easily interchangeable vessels from 100 ml to 5 litres which can be configured to suit the chemistry and scale needed for each project. Ava software control is installed, allowing control loops, programmable operations and data logging.
- Radleys Carousel 12 Plus Reaction Station™: The patented Carousel 12 Plus simultaneously heats/cools, stirs and refluxes multiple samples under an inert atmosphere. An effective personal synthesis station for parallel solution phase chemistry and solid-supported reagent-based synthesis.
- Radleys Reactor-Ready™ Pilot Lab Reactor: Three systems, allowing multiple vessel configurations from 5L to 20L with low temperature (<-60°C) capability.
- Amigochem Integrity 10™ Parallel Reaction Block: The Integrity 10™ reactor block supersedes the very successful model RS10 (over 400 units installed world-wide). The new unit incorporates a huge wealth of user experience into an enhanced design. Enhancements include refined temperature control and improved reliability via the removal of the reactor cells from the electronics compartment.
- HEL ChemSCAN II | Catalyst Screening & Parallel Process Development System: Fast, efficient screening of 8 reactions up to 200 bar. The ChemSCAN II is a dedicated parallel reaction system for the rapid development of high-pressure reactions and heterogeneous catalysis systems.
- HEL TSu | Thermal Screening Unit for Explosion Hazards Liquids and Powders: Rapid screening of thermal hazards using 0.5 to 5g sample to generate both temperature and pressure data. Hence this can be considered an improvement over the classical DSC method.
- Teledyne CombiFlash Torrent®: The next generation for scale-up of flash purification. This system offers method development and development scale purification of 300g sample per run using flow rates of up to 1 litre per minute.
- Analytical Separations: UPLC and HPLC with UV, diode array and MS detection. GC/FID with headspace and split injection.
- Spectroscopy: FTIR, multinuclear NMR, UV, GC/MS and accurate mass electrospray LC/MS. Access to ICP via external contract analysis.
- Classical Methods: Karl Fischer, automated titrations, loss on drying and sulfated ash.
- Physical Properties Testing: XRPD, Laser Diffraction Particle size, DSC, TGA and access to other physical properties characterisation techniques via external contract analysis.
- Stability Testing: Execution of forced-degradation studies and ICH Q1a/Q1b stability testing suitable for development purposes or CMC regulatory submissions.
Contact us for any business enquiry.