Almac's 240,000ft2 US headquarters, built on 40 acres in Souderton, Pennsylvania, is part of the company's integrated services solutions strategy.
The facility delivers full service, integrated clinical packaging, drug-supply management and technology solutions to pharmaceutical and biotech clients.
The lab provides support for clinical packaging operations, as well as standalone analytical services.
The labs are equipped with the latest equipment, including HPLC, UPLC, GC, UV, IR, DSC and KF.
The new group will also offer polymorph, 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.
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 customers.
The new analytical facility complements Almac's specialty capabilities, including biocatalysis, Radiolabelling, 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.
