Analytical development

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A full complement of advanced analytical and information technologies

Alcami offers a fully-integrated analytical method development, method validation and testing solution with a full complement of advanced analytical and information technologies. From Alcami’s electronic laboratory notebook (ELN) data collection system to its integration with our formulation development, project management and quality systems, Alcami’s cGMP analytical laboratories are arranged to maximize efficiency and flexibility and deliver results.

Alcami has the flexibility to provide stand-alone analytical development solutions or comprehensive analytical support for pharmaceutical development programs.

Alcami’s analytical development, validation and analytical testing services include:
  • Drug substance and drug product stability indicating assays
  • Related substances, chiral purity, elemental impurity and residual solvent analysis
  • Dissolution testing with UV and HPLC backend
  • Preservative and stabilizing excipients assays
  • Phospholipid and fatty acid analysis
  • Physical & structural chemistry
  • Remedial method validation / method life-cycle evaluation studies
  • Drug substance and reference standard material characterization
  • Reference standard qualification
  • Process validation support
  • Cleaning method verification
  • Drug product comparator studies
  • Material contact studies
  • In-use and administration set compatibility studies
  • Leachables and extractables studies
LEACHABLE AND EXTRACTABLE ANALYSIS

Assessment of leachable and extractable compounds is an analytical imperative, one that ensures the overall quality of the drug product is not impacted by its container or closure. Alcami understands this fundamental course of testing and analysis is an important aspect of any new drug product or device submission and an important milestone on the critical path to drug commercialization.

Federal regulators prescribe their guidance in 21CFR211.94(a): “Drug product container and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality or purity beyond the official or established requirements.” Similarly, 21CFR600.11(h) “All final containers and closures shall be made of material that will not hasten the deterioration of the product or otherwise render it less suitable for the intended use.”

Our scientists have a thorough working knowledge of plastics, rubber and elastomeric materials, those compounds most frequently used in today’s pharmaceutical manufacturing, packaging and delivery technologies. Equipped with a wide range of compliant qualified instrumentation and working under cGMP guidelines, Alcami’s analysts are able to perform timely, efficient trace analysis necessary to support our customer’s applications and speed them to market.

A proper assessment includes studies to not only understand which compounds have the ability to leach into the drug product, but also studies to identify which compounds the drug product may extract from the surfaces it contacts. Innovation in this space is arriving quickly and there are many new drug delivery devices and primary packaging materials to be considered and consequently assessed for their risk:

  • Metered Dose Inhalers
  • Dry Powdered Inhalers
  • Nasal Spray pumps
  • Pre-filled syringes
  • Parenteral solutions in bags and vials
  • Lyophilized products
  • Liquid oral products
  • Ophthalmic products
  • Surfaces contacted during manufacture including piping, tubing, flanges and connectors, filters, valves and single-use disposable bags and containers. 

 For additional information please call (800) 575-4224 or e-mail Account.Sales@Alcaminow.com