Johnson Matthey recently expanded its Cambridge facility to add process development and small-scale manufacturing capabilities. Brian Fairley and Antonio Zanotti-Gerosa explain how this will benefit pharmaceutical manufacturing
Johnson Matthey’s facility in Cambridge, UK, is a recognised centre of excellence for catalyst discovery, chiral technologies and process identification. Earlier this year the company expanded the facility to add process development and small-scale manufacturing capabilities to the site, which also now incorporates the company’s recently acquired Pharmorphix solid form services business.
Johnson Matthey Fine Chemicals provides pharmaceutical services, active pharmaceutical ingredients (APIs) and catalyst technologies for companies in the pharmaceuticals, fine chemicals, agrochemicals and flavour and fragrances industries worldwide. The fine chemicals division’s teams of scientists work in an integrated fashion across eleven global sites to deliver broad services through four core offerings: catalysts, controlled substances, custom pharma solutions and APIs & life cycle management.
Until recently, the Cambridge facility largely focused on catalyst discovery and route identification. “It was recognised as a centre of excellence for catalytic processes and the development of new catalysts, for both chemo- and biocatalysis. Over the past fourteen years, it has become an important hub for catalyst development within Johnson Matthey,” said Antonio Zanotti-Gerosa, R&D director.
“We focused on four key aspects: heterogeneous catalysts for reductions, such as palladium carbon or sponge metals; coupling catalysts, such as homogeneous palladium catalysts; homogeneous reduction catalysts, such as those used in achiral reductions and other asymmetric catalyses; and also biocatalysis, which was strongly enhanced by our acquisition of X-Zyme in 2008.”
In Cambridge, these capabilities were limited to catalyst R&D and bench-scale manufacturing, typically up to 100 grams. “We usually worked with customers on specific transformations, developing new catalysts, and providing feasibility or proof-of-principle studies. Our projects have qualified numerous catalysts, such as palladium carbons or coupling catalysts, for transformations that have then gone on to be scaled up at the customer’s site,” Zanotti-Gerosa added.
Broadening the capabilities of the Cambridge facility to support scale-up and non-GMP kilo-scale manufacture of APIs was a driving force behind the expansion. Brian Fairley, director, business operations, explained: “We can now provide an integrated and synergistic approach to meeting customers’ catalysis, API development and scale-up needs. Our catalyst teams will be working closely with the development teams to ensure all parameters are considered during scale-up of the catalytic step.”
Fairley added: “The expansion also means we can also work on other steps of customers’ API synthesis and this is important because their specific catalyst requirements are often just a small component of a much greater goal, to identify the overall most efficient and sustainable manufacturing routes.”
Services at the site now include route scouting, process development, optimisation and scale-up of heterogeneous, homogeneous and biocatalytic processes, as well as non-GMP kilo-scale manufacturing of APIs and intermediates for pre-clinical and toxicology studies. Johnson Matthey Fine Chemicals already offers development and kilo-scale manufacturing services at some of its other global sites, but being able to provide these in Cambridge is advantageous for many local pharmaceutical companies. Once the product moves through development and receives necessary approvals, the project can be transferred seamlessly to the fine chemical division’s other European or US-based facilities for GMP manufacturing of clinical supplies, according to the customer’s needs.
“These early stage pre-clinical capabilities are an important addition to the Cambridge site, particularly given that this site serves many innovator customers from the growing Cambridge biotech hub who are developing new chemical entities (NCEs),” Fairley explained. “We’ve seen this at our Massachusetts site, which works closely with customers around the major Boston biotech hub, and found that such customers place great importance on being able to work closely with our chemists and analysts on-site, to be able to view the chemistry and receive local support to pre-clinical supplies and beyond.”
“In a recent example, one of our customers moved very quickly from early phase clinical development to very late phase clinical development and that would not have happened without the valuable expertise that our Cambridge scientists were able to bring,” Fairley continued. “We see these types of opportunity increasing now that we have our development and catalytic capabilities working hand-in-hand at the site.”
In October 2015, Johnson Matthey announced the acquisition of the Pharmorphix solid form sciences business from Sigma-Aldrich, bringing a number of specialist services and differentiating technologies to complement the fine chemicals division’s existing analytical capabilities. “Pharmorphix is fully integrated into our expanded Cambridge site, providing valuable solid-state expertise that’s immediately available to strengthen our early-stage API development services,” Fairley said.
The newly completed Cambridge expansion adds significant capability, as it will accommodate double the previous numbers of process R&D scientists, with twice as many fume cupboards, and two new kilo labs with a 20-litre hastelloy hydrogenation vessel that can operate at up to 50 bar pressure. “
The expansion will also bring opportunities for the fine chemicals division to collaborate with the wider Johnson Matthey group, by making available its internal expertise for any catalytic development projects within Johnson Matthey’s Process Technologies, Emission Control Technologies and Precious Metal Products divisions.