Almac Sciences: a global supply chain approach

December 5, 2007

05 Dec 2007. With its distinctive “subway map” ad. and marketing campaign, the Almac Sciences network (Hall 16 Stand A75) has numerous stations and no shortage of connections.

Main lines run through contract R&D, custom manufacturing and analytical services. But the standout features are in niche areas and, increasingly, in what VP Commercial Operations Dr. David Moody sees as exceptionally wide ranging service “connectivity” – and the business model that delivers the offer.

Almac Sciences niche specialisms include the ability to deliver potents at 100+ kg scale, cytotoxics at 10s kg scale, chirals and biocatalysis, micronisation, custom synthesis of various peptide classes including peptide cytotoxic conjugates – and cGMP and non-GMP 14C labeling of NCEs from small molecule chirals to long peptides.

Three developments this year have already underlined the strength of Almac Sciences’ niche capabilities and its ability to partner with other key players in a global supply chain.

The first was its announced certification by Safebridge® in the safe handling of potent pharmaceutical compounds for its cytotoxic and potent compound manufacturing operations. Certification covers facilities, containment equipment, procedures and personnel training at the division’s Craigavon, Northern Ireland facility. Almac became the first CMO in Europe to achieve the coveted status.

Simultaneously, it announced collaboration for cytotoxic fill-and-finish services with the Coldstream Laboratories, Lexington, Kentucky – and a key chiral technology agreement with BioCatalytics Inc..

Total supply chain:

“We continue to meet our customers’ diverse and increasingly complex needs by combining Almac’s world class capabilities with complementary services of other leading industry players”,

says David Moody.

“That means a total supply chain approach to manufacturing, with high-flexibility from mgs. to tons, irrespective of complexity and regulatory status – and a very special approach to key customers and preferred supplier relationships”.

In the Almac Sciences model,

“global manufacturing”

means the best manufacturing solution, using appropriate large scale API assets – anywhere. As Business Development VP Dr. Rosaleen McGuckin says:

“Given our chemistry, technology and tech transfer skills, the key is often in project management at scale – and adding value within a deep technical relationship with each chosen manufacturing partner”.

Making it happen:

Almac Sciences’

“Supply Chain Solution”

model connects manufacturing chemistry, raw material management, tech transfer and supported manufacture to deliver

“quality on time in full”.

It calls for breadth in manufacturing capabilities, range of manufacturing scale(s), with cost effective asset options and commitment to HSE and to strong, enduring relationships – all combining to maximize speed and flexibility while controlling cost.

According to Dr. Moody:

“Making this happen in practice needs to connect the learning from previous campaigns; targeted process development; effective technical transfer and a collaborative approach to manufacture and project stewardship”.

In a recent example for a US customer, Almac Sciences faced significant raw material supply, quality and timescale challenges.

Applying its

“Supply Chain Solutions”

model it developed a custom raw material manufacturing process, with supply chain construction and management and a

“joint task force”

approach to technology transfer with the appointed manufacturer.

This drove specific gains in process development and improvement, delivering improved yields and operability. Crucially, it also achieved

“de-risked”

future raw material supply.

Once the project was running, Almac Sciences were present for the first run of each step, followed by daily (operational) and weekly (project team) teleconferences to share learning and gains.

Almac was able to supply the customer with QUOTIF against challenging timelines, while achieving all aspects of process economics.

About Almac

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to over 600 companies including all the world leaders in the pharmaceutical and biotech sectors. The company is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

Contact: Dr Rosaleen McGuckin

T: + 44 (0)28 3833 2200

E: sciences@almacgroup.com

W: www.almacgroup.com

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