Sai Life Sciences has expanded its process chemistry research and development (R&D) laboratory at Alderley Park, UK, doubling the number of scientists and enhancing the technical capabilities of the Manchester site.
The site operates as a centre of excellence for active pharmaceutical ingredient (API) process and analytical development and the expansion has increased Sai鈥檚 capabilities to support its customers鈥� new chemical entity development programmes.
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The site has been fully operational since August 2020 and the expansion was completed in June 2022.
The Manchester facility has 24 staff members and accomplished multiple projects involving complex chemistry.
The expansion brought the number of scientists at the site to more than 50.
Location
The centre of excellence for small molecule API process development is located in the centre of the Alderley Park biotech and life-sciences ecosystem, a hub dedicated to the advancement of research and innovation.
A part of the Bruntwood SciTech network, Alderley Park has access to a range of companies across the pharmaceutical sector.
It houses more than 60 established and 150 preestablished companies.
Amenities at the cluster include a conference centre with a 232-seat auditorium and meeting space, a restaurant, a gym, and outdoor sports facilities.
Sai Life Sciences鈥� Process Chemistry R&D laboratory expansion details
The expansion within the Park鈥檚 Mereside Campus increased the floor space four-fold from 5,000ft虏 to 20,000ft虏.
The expansion encompasses the addition of a new chemistry and analytical lab, as well as an increase in its fume cupboard provision from 24 to 80 fume hoods.
It helps the company to meet the increasing demand from clients across the UK, other parts of Europe, and the US.
This expansion has broadened the company鈥檚 suite through the addition of new capabilities in the areas of process analytical technology, crystallisation development, and analysis of physical properties.
Other capability additions include advanced screening and analysis tools such as the Integrity 10 parallel screening tool, Open Access GCMS, Chiral HPLC, 400 MHz NMR, and physical properties analytical equipment, as well as accurate mass LCMS.
The Manchester site has also undergone further expansion with the addition of a GMP Kilo laboratory in March 2023.
The new GMP Kilo Lab at Sai Life Sciences enables the company to supply drug substances and intermediates in gram-to-kilogram quantities, accelerating the delivery of products to meet customer clinical requirements.
The laboratory’s process capabilities include a single process stream featuring two vessels, each with a capacity of up to 35 litres, and the infrastructure to accommodate additional process streams in the future.
This process stream is complemented by contained filtration and drying equipment capable of achieving a containment level of 1渭g/m鲁.
Furthermore, the laboratory offers analytical method validation and analytical services to facilitate batch release.
These services are complemented by stability studies designed to expedite regulatory submissions.
In September 2022, the company disclosed its intention to recruit 15 new employees to enhance the expertise of its scientific team.
These roles span across analytical, chemistry, engineering, and particle sciences departments.
Details of the existing Manchester site
Sai Life Sciences鈥� facility at the Alderley Park site is its first location in Europe.
The laboratory acts as a vital link to the company鈥檚 Indian manufacturing sites while facilitating smooth integration with its service portfolio across the US and India.
The services cover areas such as drug discovery and development through to commercial-scale production.
With 5,300ft虏 of process chemistry and R&D laboratory space, the site offers route scouting, control strategy definition, good laboratory practices toxicology material preparation, and consultancy services for International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use M7, and chemistry, manufacturing and controls regulatory affairs.
It is installed with a variety of instruments and capabilities, including Buchi Versoclave, Kiloclave pressure systems, Radley鈥檚 reaction station, Amigochem Integrity 10 parallel reaction block, HEL ChemSCAN II, and Teledyne CombiFlash Torrent.
The facility allows pharmaceutical and biotech companies in the UK and EU to have face-to-face collaboration with its scientists and encourage interactions with US-based customers.
It is expected to provide world-class development, scale-up, and technology transfer to the company鈥檚 facilities in India.
Marketing commentary
Sai Life Sciences is among the fastest-growing contract development and manufacturing organisations in India.
It is the first Indian company to establish a facility at Alderley Park.
The company is working with global biotech and pharmaceutical firms to support the discovery, development, and production of complex small molecules and facilitate the introduction of 25 new medicines by 2025.
Sai Life Sciences announced plans to invest $150m between 2019 and 2023 in people and culture, processes and automation, and infrastructure and scientific capabilities.
