Onyx is now licensed to manufacture commercial API from our UK facility
As a small molecule CDMO, Onyx Scientific’s UK and US locations support customers with a range of integrated CMC services; from process R&D through to commercial API manufacturing.
Bringing together our world-class chemists and industry know-how, we are addressing global small molecule API supply needs for even the most challenging compounds.
Following expansion in 2021/22, our UK facility now spans two sites, Silverbriar and Wayfarer (each over 3,000 square metres).
Our Silverbriar facility is home to our PR&D and non-GMP small scale custom synthesis laboratories. This facility also houses our dedicated solid state laboratories alongside our non-GMP analytical method development team.
Our Wayfarer site is home to our MHRA-accredited laboratories (ISO 8) for GMP manufacture of Phase I to III clinical trial materials. Within this we have six GMP suites, each with capacity for 2x50L vessels, dedicated ovens, rotary evaporators and large scale column chromatography (if required). The facility is also licensed for the manufacture of low volumes of small molecule commercial APIs and is particularly suitable for orphan drugs. To support GMP production, this site also houses our GMP analytical laboratory alongside our stability testing facilities.
Wayfarer is also home to our non-GMP kilo-laboratories. This area consists of four laboratories (each capable of containing four 50L vessels) a separate oven room and dedicated areas for rotary evaporation and large scale column chromatography.
For over 20 years, Onyx’s FDA-accredited pilot facility in the US has provided GMP manufacturing services across three multi-purpose GMP manufacturing suites up to 2,000 gallons / 8,000 litres. With R&D facilities situated alongside GMP analytical laboratories (including stability testing), we offer all the advantages of internal tech-transfer for gram quantity processes through scale-up to multi-ton commercial small molecule API manufacture.