Almac

The Almac Group is an established CMDO providing integrated drug development services to the Biopharma industry.

Addressing the pressure to bring clinical candidates through the pipeline more efficiently and at a lower cost, Almac provides an integrated CMC service, bridging the gap between drug substance and product development.

An established provider of both drug substance (advanced intermediates and API – small molecules and peptides) and drug product development services, our clients are assured of scientific continuity from a dedicated project team, resulting in significant time and cost savings.

Integrated teams within Chemical and Pharmaceutical Development work closely to understand the physicochemical properties of the API to ensure the optimum chemical entity for clinical supply manufacture. By routinely applying innovative technology solutions, we provide alternative synthesis options which are scalable, safe and economic.

For First-in-Human or later phase development, manufacture or registration batches, Almac have access to a wide range of innovative technologies for both potent and non-potent solid oral dose products.

Having chemical and pharmaceutical operations at the same campus allows for optimal communication and knowledge transfer, exploiting the Almac advantage of a single-partner approach. Smoothing transition through the drug development process and commercialisation reduces the uncertainties inherent in a multi-supplier multi-site process.

Through our continued investment in the expansion of our state-of-the-art services, Almac ensures continued support across the product development lifecycle.

Type of Drugs Manufactured:

Small Molecule

CDMO Services:

Drug Product Formulation (FDF);Research & Development;Clinical Trials materials and logistics;Packaging;Regulatory Services;Analytical Development

No. of Manufacturing Facilities:

3-5

High Potent Products capabilities:

OEB 3;OEB 4-5

Facilities Locations:

Europe;North America

Regulatory Approvals for facilities:

FDA (United States);EMA (Europe);ISO;GMP;Health Canada;ANVISA (Brazil)

Manufacturing Technologies:

Liquids;Solids