Contract Development and Manufacturing Organisation

Almac

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.more

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs nearly 5,000 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

Our comprehensive range of integrated services includes:

Diagnostics

We offer clients a highly Customised CDx partnership approach with tailored solutions, utilising complex biology, to help you differentiate your drug in the marketplace. Our diagnostic experience spans oncology, immunology, CNS and infective diseases.

Biomarker Discovery & Development

Our services range from pre-clinical biomarker discovery, through to full companion diagnostic development and clinical test delivery from our CLIA laboratory.We have a portfolio of proprietary discovery arrays and extensive experience and expertise working with formalin fixed paraffin embedded (FFPE) tissue.

API Services & Chemical Development

We provide services for all stages of drug development for small molecules, potent and cytotoxic compounds, and peptides. Our services include API supply, drug product development, stable and radiolabelling, solid state services and biocatalysis.We also offer rapidd™, a lean, efficient, integrated package from selection of pre-clinical candidate to Phase I regulatory submission.

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 - Phase IV).With bespoke, in-house engineered containment solutions, we can develop and manufacture batches of solid, oral dose drug product containing potent API to an Operator Exposure Level (OEL) of 0.03μg/m3.

Analytical Services

Our analytical team delivers comprehensive solutions supporting drug substance (API) and drug product development programmes including CMC regulatory filings.Additionally we provide analytical and microbiological testing solutions for clinical and commercial drug product supply.

Clinical Trial Supply

Almac has over 20 years experience in clinical supplies and have successfully packaged, distributed and delivered supplies for thousands of clinical protocols.We work with small and large organisations alike, providing consulting services such as Drug Supply Management and Qualified Person release that enhance and supplement the global clinical supply chain, alongside our core manufacturing, packaging and distribution activities.

Clinical Technologies

Almac has been a leader in providing Interactive Voice and Web Response technologies since 1995. Through our industry-leading IXRS® integrated IVR / IWR technology, we offer flexible solutions for patient enrolment, screening, randomisation, drug assignment, inventory management, patient compliance, electronic Patient-Reported Outcomes, and adaptive trials. Our experienced teams help clients streamline R&D, maximize site workflows and improve overall trial management.

Commercial Services

Ensuring a simple technology transfer process, we offer integrated commercial services for all drug products from manufacturing, testing and packaging to end-user distribution. Specialising in the manufacture and primary packaging of solid oral dosage forms and with a wide range of packaging technologies we also provide customised secondary labelling and packaging for biopharmaceutical products. Integrating EU import testing, packaging, QP release and distribution, we can assist non-European companies launching orphan drug or niche products into the European marketplace.less

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Almac
Almac House, 20 Seagoe Industrial Estate,
BT63 5QD, Craigavon
Northern Ireland

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