State-of-the-art Analytical Services facility in the USA

State-of-the-art Analytical Services facility in the USA

What We Do:

Our state of the art, dedicated analytical labs provide analytical testing services for both drug substance and drug product including:

  • Analytical Method Development
  • Analytical Method Validation
  • Identification
  • Assay
  • Impurities, related substances
  • Dissolution and comparative dissolution
  • Water
  • Content uniformity
  • ICH Stability Testing
  • Commercial product release testing
  • Clinical trial materials batch release testing
  • Blinded comparator release testing and stability testing

How We Do It:

Our analytical labs are equipped the latest equipment to provide you with the best service:

  • Assay, impurities, related substances, content uniformity (HPLC, UPLC)
  • Residual solvent (GC)
  • Dissolution (dissolution baths, auto-samplers, UV/VIS, HPLC, UPLC)
  • Identification testing (IR, HPLC, UPLC, UV/VIS)
  • Physical characterization (DSC, IR, KF)
  • Water analysis (KF, Coulometric, volumetric and oven methods)
  • Stability studies (ICH conditions 25C/60%RH, 30C/65%RH, 30C/75%RH, 40C/75%RH, 5C, -20C, and photostability chambers)
  • Full blinded (over-encapsulated) comparator analysis

We have performed numerous comparator analytical projects, starting from blinding feasibility study, blinding (over-encapsulation) formulation study and blinded comparator release testing such as comparative dissolution. Comparative dissolution testing requires dissolution testing of both un-modified product and blinded (over-encapsulated product) in order to confirm the blinding process (over-encapsulation) did not alter the property of the commercial product. The latest bathless dissolution apparatus and auto-samplers aid in rapid and efficient comparative dissolution method development studies.  Using the newest Waters H-Class, HPLC/UPLC systems provides maximum flexibility for developing, validating and running assay, impurities and dissolution methods.

Where We Do It:

Our labs are based in Almac’s 240,000 sq ft North American Headquarters, built on 40 acres in Souderton, PA.  Operational since 2010, the facility delivers full-service, integrated clinical trial materials packaging, drug supply management and clinical technology solutions to the pharmaceutical and biotech industry. Almac’s analytical testing capacity has doubled since its inception, and fully complements our existing analytical testing facilities in the UK.

Our Credentials:

Our professional team of skilled analytical chemists, each with an average of 15+ years experience, has a wealth of scientific experience in drug development and analytical testing.  Almac analytical teams in the US and UK have successfully completed over 100 analytical testing and stability study projects during the last two years. The analytical projects have ranged from analytical method development, analytical method validation, release testing, stability testing, to problem solving projects such as investigation of unknown products. Our analytical testing studies have supported a number of IND and NDA submissions.

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