Breaking News

Almac Doubles Development Capacity

January 14, 2013

Adds new non-GMP facility and two analytical labs

Almac has expanded its drug product pharmaceutical development services with a new non-GMP formulation development facility and two new analytical labs at its headquarters in Craigavon, doubling current capacity.
 
Although dedicated to non-GMP development, the facilities will employ all of the company’s technical capabilities of its 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. The new non-GMP facility will primarily focus on lab-scale experiments, with batch sizes ranging from <1kg up to an expected maximum of 15 kg scale for most technologies.
 
John McQuaid, vice president of Technical Operations, said, “Our priority was to ensure we had good integration of all technologies in both the non-GMP and GMP facilities. Duplicating equipment trains means that we can conduct non-GMP work efficiently and then transfer rapidly to GMP manufacturing for clinical and registration batches. We are finding that demand for non-GMP process development work has increased as clients seek to better understand their processes in line with the principles of QbD. This type of work also creates large sample sets for analytical testing and multiple stability studies, which is why it was also important that we doubled our analytical capacity in parallel.”

Related Contract Manufacturing:

Related Packaging:

Related Compliance:

  • CROs and Today’s  R&D Landscape

    CROs and Today’s R&D Landscape

    Kristin Brooks, Associate Editor, Contract Pharma||November 9, 2016
    John Lewis of ACRO discusses opportunities, challenges, and the future CRO

  • The Human Parts of Mouse Models

    The Human Parts of Mouse Models

    Julia Schueler, Head of in vivo Operations, Oncotest, a Charles River company ||October 11, 2016
    The PDX model system has come back into focus

  • Robust Assay Designs

    Robust Assay Designs

    Tim Wright, Editor, Contract Pharma||October 11, 2016
    Easing the transition from preclinical to clinical research