Sai Life Sciences opens UK lab for drug substance and intermediates
23 Mar 2023
The new good manufacturing practice (GMP) kilo laboratory will allow Sai Life Sciences, a contract research, development and manufacturing organization (CRO-CDMO) to offer drug substance and intermediates supplies, ranging in scale from gram to kilogram quantities.
The products of the lab will be used to supply client clinical requirements at an ‘accelerated pace’, the company stated.
According to the company’s COO, Sauri Gudlavalleti, the lab has been set up to be closer to the company’s customers and to provide materials required in the drug discovery and development phase.
The new laboratory space will consist of one process stream, which will include two vessels of up to 35L capacity, with an option to add more streams in the future. Sai Life Sciences has also equipped the space with associated contained filtration and drying equipment, and is engineered to provide a containment level of 1μg/m3.
The CDMOs new lab will also offer analytical method validation and analytical services to support batch release, in addition to stability studies to enable regulatory filing.
The lab will be based in Alderley Park, Manchester, where Sai Life Sciences already possesses a process R&D lab, covering 20,000-square-feet.
The Indian company established its presence in July 2020 to assist the new chemical entity (NCE) development programs of global customers. Its Alderley site possesses chemistry, non-GMP delivery, and technology transfer to its manufacturing sites in India for scale-up.
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According to the company, the additional lab space has been created as part of its ‘SaiNxt initiative’, which has seen the company make investments of over $120m (€111m) to upgrade capacity, scale up operations, expand into new geographies, and grow its employee numbers. At present, the company has over 2,600 employees across its facilities in India, the UK, and the US.
Part of this investment saw the company open a new high potency active pharmaceutical ingredients (HPAPI) manufacturing facility at the beginning of the year, located at its Bidar, India site.
The new facility covers 16,000-square-feet and is designed to handle HPAPI with less than 1 μg/m3 containment. Sai Life Sciences stated that the location holds three independent streams that are able to handle commercial scale batches.
At the time, Krishna Kanumuri, CEO of the company, outlined that the investment had been made after seeing an increase in projects involving oncology drugs that required HPAPIs.
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