Almac's new 240,000 sq. ft. North American Headquarters, built on 40 acres in Souderton, PA, north of Philadelphia is part of the Almac Group's integrated services solutions strategy. The new facility delivers full-service, integrated clinical packaging, drug supply management and technology solutions to pharmaceutical and biotech clients.
The facility has state of the art analytical labs, complementing existing facilities in the UK. The lab provides support for clinical packaging operations as well as stand-alone analytical services to our customers. The labs are equipped with the latest equipment, including HPLC, UPLC, GC, UV, IR, DSC, KF and others. The new group will also offer Polymorph and Salt Screening and Solid Form Development.
Clinical packaging projects often require a range of analytical support, from simple 'ID testing' to full method development and validation. Over-encapsulation (OE) is now a widely accepted process for 'blinding' during clinical trials. The investigational product, a potential comparator and/or placebo are blinded in hard gelatin capsules, providing visually identical products, thus removing potential bias during a trial.
Having 'modified' the products through OE, it is critical to confirm that quality and activity have not been adversely affected. Good manufacturing practice (GMP) requires that it be shown that the OE products will behave identically to the original products. This requires comparative dissolution and stability testing of the OE product. As these products now contain a hard gel capsule and sometimes filler, assay method development and validation is often required. The US group draws on the many years of method development and GMP experience that resides in the UK group.
Almac has installed the latest bathless dissolution apparatus for rapid and efficient comparative dissolution studies. Installation of the newest Waters H-Class HPLC/UPLC systems provides maximum flexibility for developing, validating and running assay, dissolution and stability methods. Large capacity Stability chambers provide all the required ICH stability conditions in the new labs.
Now that the analytical labs and stability chambers are in-house at Souderton, Almac offers a 'one stop shop', and provides an efficient and comprehensive service to our customers.
Almac's location in the Northeast US pharmaceutical corridor has allowed for the recruitment of top pharmaceutical technical talent. Dr. Aeri Park, Operations Director for the new facility commented: 'We have built a professional team of skilled scientists, each with extensive pharmaceutical industry experience. We look forward to supporting the clinical packaging operations and growing our stand-alone Analytical and Solid Form business'.
The new analytical facility complements Almac's specialty capabilities, including Biocatalysis, Radiolabeling, and peptide and protein synthesis. These services are all part of Almac's comprehensive Drug Development Services, including API and drug product development and GMP manufacture.
SOURCE Almac Group