Almac Continues Biocatalysis Business Growth With a Further $4m R&D Investment

By Almac Group, PRNE
Wednesday, October 6, 2010

CRAIGAVON, Northern Ireland, October 7, 2010 - The need for green, economic, robust and scaleable processes
for the synthesis of chiral APIs and intermediates prompted Almac (CPHI Booth
4F32) to build and fully integrate a biocatalysis group into its service
portfolio. Last year Almac launched carbonyl reductase, transaminase,
hydrolase, nitrilase, and nitrile hydratase enzyme screening kits and is
continuing to both advance the biocatalysis business - and to broaden
application of its biocatalysis expertise with a further $4m R&D investment.

The investment will be used primarily to focus around
discovery of new biocatalytic platforms that can be rapidly implemented and
scaled delivering cost effective processes to chiral intermediates. Other
areas of research will investigate hyper-activation of biocatalysts reducing
enzyme loadings, as well as development of efficient and robust drivers for
cofactor recycle and problems with equilibriums.

As anticipated, the business has advanced from the sale of
enzyme screening kits, then to screening and optimising custom
transformations, and finally to the supply of 10s then 100s of kgs of chiral

For example, preliminary screening was carried out to
demonstrate that a carbonyl reductase (CRED) bioreduction could replace a
resolution for the preparation of a chiral alcohol. Having identified a CRED
at small scale, Almac prepared a hundred grams of the chiral alcohol and
integrated it into the API process development programme.

The next step was to manufacture 30 kgs for incorporation into
the GMP API manufacture for Phase I clinical trials.

The rapid scale-up from biocatalyst screening has been the
critical success factor for the recent paradigm shift to bioprocessing
acceptance for the synthesis of APIs and fine chemicals.

"The biocatalyst is now Almac's first choice for scale-up
chemistry involving chirality as it provides efficient, clean and robust
processes. The $4m R&D investment demonstrates Almac's continued commitment
to biocatalysis, supporting further growth in our expertise and capabilities
in biotechnology", notes Head of Biocatalysis, Dr. Tom Moody.

"Clean-up" application:

The latest addition to the application of Almac biocatalysis
expertise is for the "clean-up" of chemical reactions (Moody, T. Pharma Chem,
April/May edition, 36-38, 2010). Impurities produced in multi-step processes
are often difficult to remove, particularly if they are similar in structure
to the desired product. When crystallisation or partition does not provide
sufficient purity, Almac has used a biocatalytic process to selectively
modify impurities. The impurities are then sufficiently different in physical
properties from the desired product that they can be removed using
conventional separation techniques.

"Biocatalysis provides a mild, regio & chemoselective process
to modify impurities, thus altering their physical properties to facilitate
their removal", says Tom Moody.

Notes to Editors

About Almac Group

The Almac Group comprises five closely integrated divisions offering a
broad range of services from R&D, biomarker discovery and development, API
manufacture, formulation development, clinical trial supply and IXRS
technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides
services to more than 600 companies, including all the world leaders in the
pharmaceutical and biotech sectors.

The company employs over 2,800 individuals and is
headquartered in Craigavon, Northern Ireland. US operations are based in
Pennsylvania, North Carolina and California. Almac has officially gained full
possession of its new $120m North American Headquarters, which started in
July 2008, and employees will relocate during the fall.

For more information on Almac, please visit

Contact: Tom Moody, Head of Biocatalysis, Almac, T: +44-(0)28-3833-2200, F: +44-(0)28-3833-2299. Tristan Jervis, Account Director, De Facto Communications, T: +44-(0)207-861-3838, E: t.jervis at

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