Almac Group

Summary

Contract Pharmaceutical Development Services.

Profile

For European enquiries:

Almac Group

Almac House

20 Seagoe Industrial Estate

Craigavon

County Armagh

UK

T +44 (0) 28 38 33 2200

F +44 (0) 28 38 33 2299

For US enquiries:

Almac Group

25 Fretz Road

Souderton

PA 18964

USA

T +1 (215) 660 8500

F +1 (215) 660 8501

Almac offers a broad range of drug development services from research through pharmaceutical and clinical development to commercialisation of product. Employing more than 3,300 people within facilities in the UK and US, the privately owned company has seen more than 30 years of continual growth and partners with more than 600 companies worldwide, including all the market leaders. Their unrivalled solutions include:

API Services & Chemical Development

Almac provides services for all stages of drug development for small molecules, potent and cytotoxic compounds, and peptides:

• API Development & Manufacture
• Peptide & Protein Technology
• Rapidd™ - our flexible solutions for acceleration of entry into early clinical development
• Analytical Services
Solid State Services
• Isotope Chemistry
• SelectAZyme™ offering (biocatalysis solutions)
• Flexyte™ Assays

Analytical Services

Our analytical team delivers comprehensive solutions supporting drug substance (API) and drug product development programmes including CMC regulatory filings:

• Physical & Chemical Characterisation
• Method Development & Validation
• API & Drug Product Testing
• Stability Testing

Pharmaceutical Development

Our team of highly skilled scientists can develop your clinical candidate into an optimum formulation, and manufacture drug product for all phases of clinical trial supply (Phase 0 – IV):

• Preformulation
• Early Stage Development
• Scale Up & Late Stage Development
• Clinical Trial Management
• Contained Development & Manufacture
• Analytical Services

Clinical Trial Supply

Almac has more than 20 years’ experience in clinical supplies and has successfully packaged, distributed and delivered supplies for thousands of clinical protocols:

• Clinical Trial Manufacture
• Comparator Sourcing & Blinding
• Packaging & Labelling
• Global Distribution & Supply Chain Management
• QP Services
• Clinical Supply Consulting Services
• Integrated IVR / IWR Solutions

Clinical Technologies

Almac has been a leader in providing Interactive Voice and Web Response technologies since 1995:

• Integrated IVR / IWR Solutions - IXRS® 2.0
• ePRO
• Statistical Services
• Web Drug Reconciliation
• Clinical Helpline
• Interactive Reporting

Commercial Services

Ensuring a simple technology transfer process, we offer integrated commercial services for all drug products from API supply, manufacturing, testing and packaging to end-user distribution:

• Commercial Manufacture
• Commercial Packaging
• Product Launch & Distribution

Biomarker Discovery & Development

Almac provides a wide range of biomarker solutions ranging from pre-clinical biomarker discovery, through to biomarker trial management, full companion diagnostic development and clinical test delivery from our CLIA laboratory:

• Biomarker Services
• Companion Diagnostic Development
• Biomarker Clinical Trial Management
• Internal Biomarker Discovery
• Proprietary Discovery Arrays
• Genomic Services
• Bioinformatics Consultancy
• FFPE Solutions

New Developments

• Our biocatalyst group has now doubled in size in the last year and is reaping rewards with major business growth in chiral building block supply, evolution and commercial manufacture projects as well as metabolite synthesis – another tool within our selectAZymeTM service offering.
• We have doubled our analytical capacity at our 240,000ft^<2 North American headquarters in addition to investing £1 million in our Dedicated Mass Spectrometry Laboratory at our Craigavon headquarter facility.
• US$7m expansion of our pharmaceutical development services including a non-GMP facility for the development and scale-up of solid oral dose drug products using a broad range of technologies.
• US commercial packaging facilities are to open in Q4 2012, offering commercial primary and secondary packaging of tablets and capsules into bottles, blisters, wallets and hospital unit dose formats along with secondary labeling and packaging of sterile presentations (vials, ampoules, syringes etc).
• Addition of aXcess™ platform to our suite of services providing a unique alternative to using paper based or manual systems to automate patient randomisation and supply chain management for small to mid sized studies.