East Rutherford, NJ – May 26, 2021 – Cambrex today announced the completion of an investment project at its facility in Tallinn, Estonia to upgrade its kilogram-scale laboratory to undertake the manufacture of pharmaceutical intermediates under current good manufacturing practice (CGMP) conditions.
The project includes the installation of a new 160-liter reactor train in the laboratory which will expand the site’s capabilities to manufacture material for clinical trials and allow early phase projects to be developed further at the site prior to tech transfer and scale up. Building work and installation of the new reactor and supporting equipment is now complete, and preparation for GMP qualification is underway.
The facility also houses 150-liter glass and stainless-steel reactors, which will continue to offer kilogram-scale manufacturing of materials for pre-clinical toxicological study applications.
“Our team of experts in Tallinn work closely with the Cambrex manufacturing site at Karlskoga in Sweden, and this expansion will accelerate the progression and tech transfer of projects within the early clinical development phases,” commented Joe Nettleton, President of Cambrex’s Drug Substance Business Unit. He added, “Cambrex has a commitment to investing in the capacity, capabilities and expertise within our global network of facilities, to reinforce our position as a market-leading CDMO in small molecule development, and ensure we can serve the needs of the growing market.
The site in Tallinn provides custom organic synthesis and contract research, analytical and development services, working on process development and scale-up synthesis to kilogram quantities. The facility is located adjacent to Tallinn University of Technology’s campus, allowing for strong collaborative links with the University’s analytical and chemistry departments.
In 2019, Cambrex was acquired by funds advised by Permira, a global investment firm, to continue to build upon Cambrex’s market leading position in API development and manufacturing and support the growth of its end-to-end integrated service offerings across the pharmaceutical value chain.
Cambrex is the leading small molecule company that provides drug substance, drug product, and analytical services across the entire drug lifecycle. The company provides customers with an end-to-end partnership for the research, development, and manufacture of small molecule therapeutics. With over 40 years’ experience and a growing team of over 2,100 experts servicing global clients from sites in North America and Europe, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Cambrex offers a range of specialist drug substance technologies and capabilities, including biocatalysis, continuous flow, controlled substances, solid state science, material characterization, and highly potent APIs. In addition, Cambrex can support conventional dosage forms, including oral solids, semi-solids, and liquids, and has the expertise to manufacture specialist dosage forms such as modified-release, fixed-dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile and non-sterile ointments.