CPhI: Almac and DSM ally in biocatalysis
Almac and DSM Pharmaceutical Products have announced a collaboration agreement in the use of biocatalysis in the pharmaceuticals industry
At CPhI Worldwide in Madrid on 9-11 October, Almac and DSM Pharmaceutical Products, the custom manufacturing and technology business of DSM, announced a collaboration agreement in the use of biocatalysis in the pharmaceuticals industry. This will give each access to the other's enzyme platform technologies and related services. Financial details were not disclosed.
According to Dr Tom Moody, head of Almac Biocatalysis, Almac will add about 500 different enzymes to DSM's collection, making about 3,500 available off-the-shelf. These cover all of the specific classes and many mutant types. Perhaps more importantly, it will ally Almac's early stage (Phase I-II) experience in rapid enzyme identification, scale-up and implementation with DSM's in multi-tonne commercial manufacturing bioprocesses from Phase II to commercial.
"The earlier you implement in biocatalysis in route scouting, the better," said Elise Meulenbroeks, new business development manager for DSM's InnoSyn route scouting services business, who spoke at the same press conference. "It helps to reduce costs, shorten timelines, mitigate risk and give both scientific continuity and long-term security of supply."
The two companies had already worked together on some projects and this formalises the process. The partnership, Moody confirmed, is intended to be long-term, with the aim of creating a single expression system so that any 'hit' can potentially go through to large-scale manufacture. They are discussing wider collaborations but are focusing on biocatalysis in the first instance.
Almac provides a range of enzymes, including reductases, transaminases, hydrolases and nitrilases
While stressing the green credentials of biocatalysis over traditional chemocatalysis, Moody and Meulenbroeks agreed that this is still just one tool among many. Asymmetric hydrogenation, for instance, is still very powerful and ene reductases have a long way to go to catch up with it but the interest in biocatalysis is growing strongly. "It will go on a case by case basis. We will only push biocatalysis where it is the most competitive option," said Meulenbroeks.
Speaking to SCM separately at CPhI, Denis Geffroy, vice president of business development at Almac, said that the alliance was partly about putting two portfolios together but also about complementary technologies. Hitherto, some projects have used Almac up to about 50 kg scale but then transferred to DSM.
"Rather than wait for that to happen again we decided to be proactive and each offer a more compelling service together," Geffroy said. "The alliance means that we can give indicative pricing for multi-tonne work from the start, which the chemists appreciate for planning purposes. The relationship will help when processes are transferred, as that can be a complex business, full of pitfalls."
Biocatalysis sales grew about 30% for Almac in 2011, albeit from a low base. The company is now about half way through a $3 million investment to expand its biocatalyst platform via an evaluation programme that looks at both academic and internal developments. The enzyme range, added Geffroy, is being expanded every month.
"Biocatalysis now underpins a lot of what we do. Without it, our API plant would be quite empty," he said. "In fact, it is really dominating catalysis in API synthesis. A lot of people don't even look at chemocatalysis any more. Biocatalysis not only works well, it ticks the green boxes, produces less waste and uses less solvent."
During CPhI, Almac also announced that the expansion of its API manufacturing facility at Craigavon, Northern Ireland, will be operational by the end of the year. This upgrade includes the addition of two 1,000 litres reactors and a pressure filter dryer, enabling Almac to produce APIs to GMP in batch sizes of up to 150 kg. Hitherto it had been largely limited to the 20-50 kg range.
The investment was the result of a strategic decision taken three years ago to move beyond Phase I-II manufacturing and into the later stages. At that point, Geffroy said, the company had no Phase III activity at all. Now, although it still cannot chase every late stage project, Phase III accounts for about 25% of its pipeline by volume, mostly small volume products, orphan drugs and high potency APIs.
It was also announced in Madrid that Almac's solid state services group, which was established in 2008 and has expertise in solid form characterisation, screening and selection and crystallisation process development, has created a series of pre-clinical screening packages to identify a drug candidate's chances of success much more rapidly than by using traditional mechanisms. This is claimed to be unique among solid state services companies.
The package is designed to identify candidates with drug product-like characteristics. It will use experiments to establishing the physical/chemical, solubility, stability and polymorphic characteristics of each candidate, thus enabling clients to make a rational decision for lead identification. The solid state services group is headed by Linda McAusland and employs 15 at Craigavon. Over half of the drug compounds going through development have solubility issues.
From Online Issue: October 2012