Almac’s 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).
With customised, in-house engineered containment solutions, the company can develop and manufacture batches of solid, oral dose drug product containing potent active pharmaceutical ingredients (API) to an operator exposure level (OEL) of 0.03µg/m3.
Operating from state-of-the-art, custom-designed facilities, Almac develops clinical candidates into an optimum formulation and manufactures drug product for Phase 0 to Phase IV of clinical trial supply. In-house engineered containment solutions also allow for the development and manufacture of highly potent products.
Pharmaceutical development (early phase)
Almac’s formulation scientists have many years’ experience in developing a range of oral dose formulations for early-stage clinical trials. With both non-good manufacturing practice (GMP) and GMP facilities, they can provide flexible and efficient solutions to develop a fit for purpose formulation for early phase/first-in-human (FIH) supplies.
For early phase FIH supplies, Almac offers a range of solutions:
Pharmaceutical development (late phase)
Specialising in solid oral dosage forms, Almac has the technical experience and knowledge to develop robust formulations and manufacturing processes.
Many clients have been assisted in the development of both immediate and modified release formulations for their late-stage clinical trials, registration batch manufacturing and commercial launches. Expertise includes the development of the following dosage forms: