Pharmaceutical development services, packaging capabilities and late stage API manufacturing benefit from investment
A series of significant investments in 2013 have equipped Almac to expand to meet increased demand across multiple areas of its business.
In January 2013 the company completed the doubling of its pharmaceutical development service capabilities with the opening of a new dedicated non-GMP facility together with two analytical laboratories at its UK headquarters in Craigavon in Northern Ireland.
The new non-GMP formulation development facility offers clients greater flexibility and speed in formulation and process development, creating an environment where development work can be progressed quickly and then easily transferred to the existing GMP development facility located on the same Almac UK campus.
Although the new facility is dedicated to non-GMP work, it mirrors all the technical capabilities of Almac’s existing GMP pharmaceutical development facility, including high levels of control over environmental conditions as well as extending current capabilities in processing potent compounds with low OELs.
In parallel to the new non-GMP facility, Almac doubled its analytical capacity with new analytical laboratories for processing the large sample sets that result from non-GMP process development work for clients who seek to better understand their processes in line with the principles of QbD.
Almac is continually assessing and investing in solutions to accelerate the manufacturing of our clients' clinical supplies, while ensuring quality at all times
Additionally, in response to increased client demand for preclinical and early phase clinical GMP supply, Almac has further enhanced its pharmaceutical development offering with an investment in additional Xcelodose technology. The additional Xcelodose unit comes complete with an Xcelohood providing the capability to dose potent API directly into capsules.
'Almac is continually assessing and investing in solutions to accelerate the manufacturing of our clients' clinical supplies, while ensuring quality at all times,' said John McQuaid, VP Technical Operations. 'The investments this year in the new non-GMP facility and Xcelodose equipment strengthens Almac’s position as an integrated service provider in the pharmaceutical development sector.'
In February 2013, with FDA approval, Almac opened its US commercial packaging facility, providing quality-driven, flexible packaging solutions for both solid oral dosage forms and biopharmaceutical products.
Meanwhile, expansion continued at Almac’s UK commercial manufacturing and packaging facilities, with the completion of a US client-led capital project in support of a key global product launch. This expansion has added significant capacity for commercial fluid bed drying and high speed encapsulation.
Additionally, in response to growing demand from a number of Japanese partners for enhanced flexibility related to larger blister sizes and requirement for non permeability and environmental protection, investment has also been made in state of the art blistering technology with product humidity control.
Due to record sales, growth in one of Almac’s client’s key products and entry into new markets including China, the most recent commercial expansion completed at the UK site was a client-led second investment in dedicated facilities, doubling sachet output to 250 million sachets per annum.
This level of commercial investment demonstrates our commitment to building long term, strategic relationships
'Almac is developing a strong reputation for the delivery of complex, time sensitive capital projects in support of growing, innovative products,' said David Downey, VP, Commercial Operations. 'This level of commercial investment demonstrates our commitment to building long term, strategic relationships.'
Meanwhile the expansion of its API manufacturing facilities has allowed significant growth in Almac's late stage manufacturing service. The facility upgrade included installation of two 1,000-litre reactors and state-of-the-art pressure filter dryer, which now allows production of highly potent APIs up to 500kg with a dedicated nitrogen jet mill for micronisation.
'Over the past few years, Almac’s API business has continued to grow at a double digit pace,' said Denis Geffroy, VP Business Development. 'The facility expansion was much needed and the results are already striking, with several Phase III and Commercial projects awarded.'
The facility expansion was much needed and the results are already striking
Almac’s clients also leverage its integrated offering where API manufacture and finished drug production is carried out on the same site, ensuring reduction in costs and timelines while maintaining scientific continuity. This year Almac has completed its first joint commercial API and Drug Product manufacture which demonstrated the advantages of integrated operations.
'Today, our API business is made up of 30% late phase and commercial projects, compared with just 5% three years ago, which gives a clear indication that our strategy to invest through expansion was the right one,' added Geffroy.