Analytical Development

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 deliver results.

Core Capabilities 

  • 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 and structural chemistry

  • Remedial method validation/method lifecycle 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

  • Extractables and leachables studies

  • Solid state characterization

Analytical Development


From initial characterization of drug substance to commercial batch release, each phase of your drug product development requires analytical methods to qualify the product for safety, integrity, strength, purity, and quality.  With these critical attributes in mind, Alcami’s biologics analytical development team will work with you to design a robust quality system to support every phase of your product development lifecycle.


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