Almac Opens Analytical Labs in New US HeadquartersBy Almac Group, PRNE
Sunday, February 6, 2011
SOUDERTON, Pennsylvania, February 7, 2011 - 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.
For further information on Almac's new North American Headquarters and
our service offerings please visit www.findpharmony.com
The Almac Group offers a broad range of services from R&D, biomarker
discovery and development, API manufacture, formulation development, clinical
trial supply and IXRS technology (IVRS/IWRS), to commercial-scale
manufacture. Almac provides services to more than 600 companies, including
all the world leaders in the pharmaceutical and biotech sectors.
The company employs almost 3,000 individuals and is headquartered in
Craigavon, Northern Ireland. US operations are based in Pennsylvania, North
Carolina and California. Staff has now transferred to Almac's new $120m North
American Headquarters which is now fully operational.
For more information about the Almac Group, please visit
www.almacgroup.com or e-mail firstname.lastname@example.org
For media enquiries: Please contact Tristan Jervis on: +44-771-363-8396, t.jervis at defacto.com
Tags: Almac Group, February 7, Pennsylvania, Souderton