The Almac biocatalysis group has secured a prestigious BBSRC (Biotechnology and Biological Sciences Research Council) programme with UCL focused specifically on metagenomics and novel enzyme discovery. The R&D work concerned is set to be carried out jointly between Almac and the departments of Biochemical Engineering and Chemistry at UCL, with high level input from two world leaders in the field of biocatalyst discovery and application, Professors John Ward and Helen Hailes.

Dr. Tom Moody, Almac’s Head of Biocatalysis & Isotope Chemistry, commented “This clearly adds further depth to our expertise and complements our recent collaboration with DSM in accessing diverse enzyme collections.”

Professor Ward remarked: “We are very excited to continue working with Almac on this prestigious project, building on many years of collaboration and partnership. Indeed, this project will see our internal capabilities further developed with true industrial needs in our vision.”

The application of biocatalysis technology to the pharmaceutical and fine chemical industries is continuing to grow year on year and this trend is mirrored in the increasing number of synthetic projects being carried out by the biocatalysis group in Almac.

The only limitation of biocatalysis is in the number of diverse enzymes available in a given enzyme class, which dictates both the substrate range and the stereoselectivity observed for a desired chemical transformation. The majority of enzymes used in biocatalysis are derived from microbial sources. However, it is known that only a tiny percentage (as low as 0.1% from soil samples) of bacteria present in an environmental sample can be cultured and isolated.

Metagenomics, a culture-independent technique used to extract the total DNA from an environment, can circumvent this problem and allow access up to 99% of enzyme genes present in environmental samples. Work previously carried out at UCL has allowed a series of metagenomes to be obtained from various unusual sources. The use of bioinformatic tools developed by John Ward with Prof Christine Orengo of the Structural and Molecular Biology department at UCL will allow the metagenomes concerned to be mined for enzymes usable in both synthetic chemistry and synthetic biology projects.

Moody further commented “The need for more diverse enzymes has never been greater and this research programme further emphasises Almac’s commitment to UK research and to biocatalysis development.”

He continued; “The project will mainly focus on transaminase and cytochrome P₄₅₀s enzymes. We will   identify, clone and express these enzymes before carrying out extensive screening against panels of ‘typical’ pharmaceutical and fine chemical substrates. This should enable us   to identify novel and commercially useful enzyme biocatalysts. As the follow-on step, directed evolution at Almac will enable further development of the lead enzymes concerned.

For media enquiries, please contact Tristan Jervis or Alex Heeley on +44 (0) 207 861 3938 or e-mail: t.jervis@defacto.com.

Notes to Editors

The Almac Group provides 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 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

Although Almac recruits on a rolling basis as its facilities keep expanding, the perception that only candidates with a scientific background will be considered is proving difficult to shift.

To nip this myth in the bud, Almac are hosting their very first recruitment fair to engage on a one-to-one basis with potential candidates and tease out the essential qualities for the available posts.  Visitors could well be surprised to discover that they fit Almac’s job profile requirements perfectly, and could end up stepping onto a successful career ladder before spring gives way to summer.

A total of 14 positions are immediately up for grabs in the Clinical Project Services department and will suit candidates with an organised, problem-solving mind combined with good customer skills and a knack for managing project scope and timelines. Over the next few months, eight further Project Management positions will be advertised and the fair offers the perfect opportunity to meet Almac’s recruitment specialists and be noticed.

Abi Pesun, Director of Clinical Project Services of Almac’s Clinical Technologies business unit, says “Scientific and clinical services cannot function to optimal efficiency without the essential support our existing 50 Project Managers provide. We are looking forward to bringing in more enthusiastic Project Managers with varied specialities encompassing IT, logistics, customer service and more.

“Aside from working for an award-winning business offering excellent working conditions, employees also have access to opportunities for learning and development, helping them to secure professional roots and develop within the Almac family. We hope the recruitment fair will dispel misconceptions about Almac and show that indeed it takes all kinds to make Almac the extremely successful company it has become over the years.”

The workshops will divide attendees into three different groups, each one a different component of supply chain management. Speakers will present case studies that examine issues related to clinical supply management, and all three groups – a CRO, a clinical technology services company, and a study sponsor – will approach the case study issues and devise solutions based on their assigned point of view.

Robert Dunlop, Managing Director at Almac Clinical Services, commented: “The workshops are designed to foster learning, build networks, and promote professional development amongst those in all facets of the clinical trial profession. We encourage attendees to discuss common challenges and brainstorm solutions, and hope they will take away new or improved processes that will lead to greater success.”

The venues and dates are as follows:

Copenhagen, Denmark: Palace Hotel, Tuesday April 23rd

Cambridge, UK: Trinity Centre, Thursday April 25

Basel, Switzerland: Swissotel, Tuesday May 7

Frankfurt, Germany : Hilton Hotel, Thursday May 16

Boston, MA: Hotel Marlow, Tuesday May 14

San Francisco, CA: Hilton San Francisco Airport Bayfront, Thursday May 16

Durham, NC: The Solution Center, Tuesday May 21

New Brunswick, NJ: The Heldrich, Tuesday May 24 

To register for an event near you, visit the registration sites here. Seats are limited and registration is required to secure your place. For more information about the Almac Group, please visit www.almacgroup.com or e-mail info@almacgroup.com

End

About Almac Group

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacturing, 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 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Almac’s North American Headquarters is located in Souderton, PA.

For more information about the Almac Group, please visit www.almacgroup.com or e-mail info@almacgroup.com

The inspection of the control testing laboratory was in support of pre-approval inspections for products for which Almac Sciences are named as the contract test laboratory. The 3-day inspection covered the Quality and Laboratory Control systems and included tours of all test laboratories and specialist analytical facilities including mass spectroscopy laboratories. .

Commenting on the approval, President and Managing Director, Stephen Barr said:

“We are delighted with the outcome of this inspection.  We have now established a track record with both authorities which highlights our strong focus on compliance and regard for regulatory standards.  This outcome is even more significant with the completion of our expanded API facility, and focus on late phase clinical development projects.  Our clients can be further assured that our systems and procedures are robust and their products will be delivered to the highest quality.”

Alan Chambers, Head of Quality Assurance added,

“This success confirms Almac’s dedication to delivering the highest quality standards.  To complete this inspection with no findings is testament to the knowledge and expertise of the entire Almac workforce.  We are committed to building on these strong foundations with continual investment within our quality systems.”

Almac  is also pleased to announce expansion of its manufacturing and support facilities at its Craigavon plant. These include an extended API facility, which doubles the current GMP Active Pharmaceutical Ingredients (API) manufacturing capacity, and expansion of its stability storage chambers with also a doubled capacity increase.

For media enquiries, please contact Tristan Jervis or Alex Heeley on +44 (0) 207 861 3938 or e-mail: t.jervis@defacto.com.

Notes to Editors

The Almac Group provides 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 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

The agreement grants both parties access to their enzyme platform technologies, services and expertise for the manufacturing of active pharmaceutical ingredients (APIs). Almac’s expertise in rapid enzyme identification, scale-up and implementation into early phase projects complements DSM’s experience and track record of over 30 commercial manufacturing bioprocesses run on a multi-ton scale.  This gives customers of either party access to enzyme expertise and assets resulting in cost-effective, green processing at all phases of development from preclinical to commercial manufacturing scale.  The collaboration also enables Almac to offer its customers a preferred partner for large-scale production.

Since then, Almac and DSM have initiated and completed multiple projects together in the fields of ketoreductase, transaminase, biooixdation and hydrolase.  Having access to the largest portfolio of off-the-shelf enzymes has really aided in moving projects from conception to reality for customers of both companies.

Dr. Tom Moody, Head of Almac Biocatalysis, stated “The success of the projects undertaken between Almac and DSM already demonstrates there is a market for scalable green technologies to access difficult-to-make chiral chemicals.  Cost remains a prevalent issue within the industry and the introduction of enzymes into processes earlier in the drug discovery pipeline helps to drive cost down as projects move forward.  Our collaboration is delivering real rewards to clients from both a technical and financial perspective”.

Almac’s success in the biocatalysis field was further endorsed recently, by the completion of the Knowledge Transfer Partnership (KTP) with Queens University Belfast to develop, improve and embed bioprocesses in order to facilitate the delivery of novel products for its biocatalysis business.  The project was awarded the highest grade of “Outstanding” by the KTP Grading Panel for it’s achievement in meeting KTP’s objectives.

Notes to Editors

About Almac

The Almac Group provides 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 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

For more information about the Almac Group, please visit www.almacgroup.com or e-mail info@almacgroup.com

About DSM – Bright Science. Brighter Living.™

Koninklijke DSM NV is a global science-based company active in health, nutrition and materials. By connecting its unique competences in Life Sciences and Materials Sciences DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders. DSM delivers innovative solutions that nourish, protect and improve performance in global markets such as food and dietary supplements, personal care, feed, pharmaceuticals, medical devices, automotive, paints, electrical and electronics, life protection, alternative energy and bio-based materials. DSM’s 22,000 employees deliver annual net sales of about € 9 billion. The company is listed on NYSE Euronext. More information can be found at www.dsmpharmaceuticalproducts.com and www.dsm.com.

The event offers attendees peer-delivered case studies, extensive networking opportunities and the most current industry insight. It will provide a platform for Almac’s Dr. Mike Hutton to deliver a presentation entitled: “Smart Standardization for IVRS/IWRS: Determining a Standard Approach while still Retaining Flexibility”” Supply Chain Management Expert Martin McGlone will be onsite for one-to-one consultations throughout the duration of the two day conference.

Looking forward to the event, Mr McGlone commented; “Almac has been listening to its client’s needs and we are committed to delivering innovative and cost-effective solutions in line with trial timelines through the use of market-leading technologies (IXRS) and our dedicated Supply Chain Management personnel,“ adding “We are delighted to be attending CTS Europe again this year to share thoughts on delivering efficiencies in the clinical trial supply chain with our industry colleagues.”

To register for the 14th Annual CTS Europe conference, visit the website.

For more information about the Almac Group, please visit www.almacgroup.com or e-mail info@almacgroup.com

Notes to Editors

About Almac

The Almac Group provides 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 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

For more information about the Almac Group, please visit www.almacgroup.com or e-mail info@almacgroup.com

Commenting on the inspection, Ian Markwell, Vice President of Quality, said: “We are very pleased with the outcome of our inspection, as it marks the establishment of our US commercial packaging operations with FDA approval for bottle, blister, wallet and vial labeling/packaging.”

Jim McGibbon, US Director of Business Development explained “We are now able to meet the growing market demand for quality led, flexible commercial packaging solutions in the US. Now having been successfully inspected by the FDA, we are ready to commence operations for our first client.”

Almac’s first US commercial packaging client, a US-based diversified healthcare company, is an existing long term client partner of  its UK operations for both formulation development and contract commercial manufacture services. Initially Almac will supply three commercial products with bulk tablet and capsule manufacture taking place in Almac’s EMA and FDA approved commercial facility in the UK, with final bottle and blister packaging taking place in Audubon.

“This is a significant first contract for the Audubon facility filling in excess of 4M finished packs per annum, so it’s proving a busy start to the year!” added McGibbon.

Almac’s new FDA approved, US commercial packaging facility in Audubon, PA, offers flexible packaging solutions from primary packaging of solid oral dosage forms to customized secondary labelling and packaging of sterile biopharmaceutical products for both established US products and niche/orphan drug launches alike.

Notes to Editors

The Almac Group provides 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 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

The overall partnership aim was to allow technology transfer of fermentation and molecular / microbiology expertise from Queens University to Almac.  Almac met the specific partnership objectives by not only sharing a program of work with academics at Queens, but also attending training courses organised through University College London and embedding key learning back into the company.

The resulting success of this collaboration is that Almac can now deliver a fully integrated fermentation, optimisation and bio-product service to its customers.  Since completion of the KTP, Almac have successfully scaled fermentation and bio-oxidation reactions to thousands of litres.

Dr Tom Moody, Head of Biocatalysis and Radiolabelling Services, is understandably delighted with the results of this partnership: “To receive the highest grade of Outstanding is a huge achievement for Almac, and testament to the commitment of the team involved.  Not only have we further strengthened our long-standing relationship with Queens University, but we have also increased our service offering within the biocatalysis field to our clients, thus allowing us to compete in an area which was previously beyond our reach.”

This achievement follows from an extremely successful year for Almac’s biocatalysis service offering.  2012 saw the launch of its metabolite synthesis services, winning a Belfast Telegraph Award in Excellence in Technology, and announcing an industry-leading biocatalysis collaboration with DSM Pharmaceutical Products.

Notes to Editors

The Almac Group provides 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 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

The new non-GMP formulation development facility offers clients greater flexibility and speed in formulation and process development, creating an environment where development work can be progressed quickly and then easily transferred to the GMP environment at an appropriate stage. Although the new facility will be dedicated to non-GMP work, it mirrors all the technical capabilities of Almac’s existing GMP pharmaceutical development facility, including high levels of control over environmental conditions as well as extending current capabilities in processing potent compounds with low OELs.

Whereas, the existing GMP facilities can support drug product manufacturing from phase I up to registration and commercial scale, the new non-GMP facility will primarily focus on lab-scale experiments, with batch sizes ranging from <1kg up to an expected maximum of 15 kg scale for most technologies.

John McQuaid, VP of Technical Operations explains “Our priority was to ensure we had good integration of all technologies in both the non-GMP and GMP facilities.  Duplicating equipment trains means that we can conduct non-GMP work efficiently and then transfer rapidly to GMP manufacturing for clinical and registration batches.  We are finding that demand for non-GMP process development work has increased as clients seek to better understand their processes in line with the principles of QbD. This type of work also creates large sample sets for analytical testing and multiple stability studies which is why it was also important that we doubled our analytical capacity in parallel.”

The Almac Group provides a broad range of pharmaceutical 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 3,300 and is headquartered in Craigavon, Northern Ireland. Its North American Headquarters are in Souderton, Pennsylvania and the company also has sites at North Carolina and California.

FLEXYTE™ assays harness the power and potential of fluorescence lifetime technology

Almac and TTP Labtech announced today the formation of an alliance in the field of fluorescence lifetime (FLT) technology to provide class leading screening performance. This will give customers of either party access to a broad range of biological applications coupled with the next generation of microplate reader technology.

FLT as a reading modality offers a robust, antibody-free, homogeneous assay platform which enables the user to avoid interference from fluorescent compounds within a screening library. Developed utilising experience in peptide engineering and chemical synthesis and design, Almac’s FLEXYTE™ assays harness the power and potential of FLT to provide an efficient and economical platform for screening and profiling. The evolving assay platform offers solutions for many major therapeutic target classes including kinases, proteases, phosphatases, DUB and an increasing number of epigenetic targets.

TTP Labtech’s Ameon™ system represents the next generation of FLT reader technology. By offering real-time decay curve analysis, the Ameon™ system provides a revolutionary combination of speed, precision, and data quality for FLT assays that can be readily integrated into HTS workflows.

‘The development of the Ameon™ reader by TTP Labtech has introduced an exciting new dimension to FLT technology and we are pleased that Almac’s FLEXYTE™ customers will be able to benefit from this advance in reader technology’ said Dr Stephen Barr, President and Managing Director of Almac Sciences.

‘We are excited by the potential of the FLEXYTE™ and Ameon™ reader combination to deliver robust, cost-effective screening results and enhanced productivity through better discrimination of lead compounds’ said Dr Wayne Bowen, Chief Scientific Officer of TTP Labtech.

Video Interview:

Wayne Bowden from TTP Labtech tells SelectScience how this alliance will give customers access to a broad range of biological applications coupled with the next generation of microplate reader technology. Wayne also tells us more about TTP Labtech’s Ameon™ system, which represents the next generation of FLT reader technology. In addition Robert Grundy from Almac discusses how FLEXYTE™ assays harness the power and potential of FLT to provide an efficient and economical platform for screening and profiling.  Click here to view

Editors’ notes

About Almac

The Almac Group provides 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 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

For more information about the Almac Group, please visit www.almacgroup.com or e-mail info@almacgroup.com

About TTP Labtech Limited

Based near Cambridge, UK, TTP Labtech creates, designs and manufactures robust, reliable and easy-to-use instrumentation to offer life scientists better tools and techniques, simplifying complex operations, saving time and material costs.

We provide state-of-the-art solutions developed for specific product areas including: cell-based screening (acumen^®, mirrorball^®); sample management (comPOUND^®), low liquid handling (mosquito^®) and the management of analytical automation (lab2lab).

TTP Labtech is owned by its employees, and our continued drive to innovate combines cutting edge science with first rate engineering, manufacturing and outstanding customer support.

For further information please visit www.ttplabtech.com