Formulation Development

Formulation Development
Product Description

Formulation development and optimization to support all stages of clinical programs.

Alcami

  • US
  • 2016
    On CPHI since
  • 1000 - 4999
    Employees
Company types
Biopharmaceutical company

Alcami

  • US
  • 2016
    On CPHI since
  • 1000 - 4999
    Employees
Company types
Biopharmaceutical company

More Products from Alcami (17)

  • Stability

    Product Stability

    Study Types-In-use studies (broaching, reconstituted product stability, multi-use container stability)
    -Formulation development studies including stress studies
    -Photostability (Options I and II)
    -Comparator studies
    -Thermal cycling/freeze thaw
    -Shipping excursion studies
    -Long-term stabi...
  • Analytical Services

    Product Analytical Services

    Method development and phase appropriate validations to support clinical and commercial programsCompendial Testing
    Raw Material Testing
  • Contract Manufacturing

    Product Contract Manufacturing

    Development and optimization of suitable manufacturing processes to support clinical and commercial programs
  • Contract Packaging

    Product Contract Packaging

    Support stand along packaging activities or integrated with Alcami's manufacturing capabilities. Can support packaging for clinical kits including kit assembly and commercial packaging.
  • Extractable and Leachable Studies

    Product Extractable and Leachable Studies

    Alcami’s expertise includes the assessment of a broad variety of drug products, routes of administration, and manufacturing system components. 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 comp...
  • Fill / Finish Services

    Product Fill / Finish Services

    Fill / Finish services to support biologics.
  • Lyophilization

    Product Lyophilization

    Developing and optimizing lyo cycles to support clinical and commercial programs
  • Tech Transfer and Scale Up

    Product Tech Transfer and Scale Up

    Tech Transfer and Scale up to support clinical and commercial programs
  • 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, ...
  • 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 devel...
  • 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...
  • Integrated offerings

    Product Integrated offerings

    Alcami is a Us-based, contract development, testing, and manufacturing organization for pharma and biotech companies. Our goal is to support our clients in making their projects go from potential to reality day-after-day.
    Core Capabilities:Sterile-fill finish development and manufacturingO...

Alcami resources (3)