Alcami

About Alcami

Alcami is a US-based CDMO for pharma and biotech companies with over 40 years of experience. Our goal is to support our clients in making their projects go from potential to reality day-after-day. Core capabilities include sterile fill-finish development & manufacturing, oral solid dose development & manufacturing, and laboratory services. For more information, visit alcaminow.com.

  • US
  • 2016
    On CPhI since
Contact info

Products from Alcami

  • Analytical development

    Product 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.
  • Biopharmaceutical development

    Product Biopharmaceutical 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.
  • Formulation development

    Product Formulation development

    Alcami’s formulation development team proactively guides your development program every step of the way – from Compound to Clinic.  Our team is adept at solving challenging formulations for new chemical entities (NCEs) and developing high-performance dose forms to meet today’s consumer needs. We offer early-phase accelerated programs for NCEs and generic drug development for human and veterinary applications (ANDAs and ANADAs).
    Alcami’s formulation development scientists provide full chemistry, manufacturing, and controls (CMC) services for drug candidates that encompass all biopharmaceutical classification system schemes (BCS Class I through Class IV) including the more challenging not freely soluble, unstable, or poorly bioavailable compounds. Our formulation and analytical experts can provide creative solutions to your toughest pharmaceutical challenges, including products with extremely low or high drug loads, poor flow, or homogeneity problems.

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