Formulation development

Formulation development
Product Description

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.

Alcami

  • US
  • 2016
    On CPHI since
  • 1000 - 4999
    Employees
Company types
Biopharmaceutical company
Specifications
  • Selling Points
    Experienced Technicians; Quality Service
  • Supplied from
    United States

Alcami

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

More Products from Alcami (17)

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

    Product Integrated offerings

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  • Manufacturing

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    Alcami offers cGMP manufacturing services with operations ready to scale in tandem with your development and approval milestones. From preclincial through commercial supply, Alcami’s development and manufacturing sites are DEA certified to manage controlled substances, APIs, and other complex compounds. Al...
  • Microbiology

    Product Microbiology

    Microbiological testing is an important factor in ensuring your product’s safety, efficacy, and timely project completion. At Alcami, we combine decades of microbiological expertise, developed from serving the biotech, pharmaceutical, and medical device industries, to provide the most current and effective...
  • Packaging and labeling

    Product Packaging and labeling

    Alcami provides custom packaging, labeling, and kitting for clinical trial materials destined for trials anywhere in the world. We also provide specialized expert support for randomization and blinding studies, including placebo, comparator, and crossover studies, as well as reconciliation drug accountabil...
  • Parenteral manufacturing

    Product Parenteral manufacturing

    Dedicated to manufacturing parenteral dosage forms, Alcami’s Charleston, South Carolina site supports preclinical production through commercial launch and supply. This US- and EU-compliant and DEA-licensed sterile manufacturing facility is fully integrated with our Wilmington, North Carolina packaging and ...
  • Solid oral dose

    Product Solid oral dose

    Specialized to manufacture oral solid dosage (OSD) forms, Alcami’s Wilmington, North Carolina site supports preclinical production through commercial launch and supply. We differentiate ourselves by providing ample problem-solving solutions to your scientific needs.  

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Alcami resources (18)

Frequently Viewed Together

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  • Product Excipient Quality Testing and Selection Services

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    ...
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    •Characterization of raw materials, intermediates, and final APIs using techniques such as HPLC, GC, MS, NMR, and XRPD. 

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  • Product Tailored Inhaled Development Services

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  • Product OTC and MD dossiers

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    Your Agile Experts
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  • Product Contract Development and Manufacturing

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  • Product Concentrate of Trace Elements Solution for Infusion (I)

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  • Product Fourier PAT

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    We offer a wide range of food supplements ready to be put on the market. Available formulations in Basic Health - Energy - Osteo and Joint Care - Immuno and Womens' Health.

    We can also realize your idea of product and offer a full customised development.


    Contact us for more info
  • Product Thermal characterization of the product

    Having information on the thermodynamic behaviour of our formula is critical to identify the critical product temperatures. At Comser, we have the following technology to characterize the product:
    - Freeze Drying Microscope (FDM)
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    Microcaps® Taste Masking and Modified Release Technology achieves uniform and efficient coating of drug particles by coacervation (phase separation) to build polymeric membranes of varying porosity and thickness. The result is a free-flowing powder containing microencapsulated API (or API substrate) in a w...
  • Product Formulation Development

    Within early development, there are a variety of different challenges that hinder a molecule’s ability to progress to the next phase such as complex formulation.

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    ...
  • Product Investigational Medicinal Product Manufacture

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    Spray-drying is an instant and continuous solvent evaporation process of a liquid feed, atomised in a heated gas, generating a final dried solidified particle.The heated drying gas moves in co-flow with the atomised feed in the process chamber where the gas transfers its heat energy to the droplets and abs...
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    Evonik is one of the world’s leading CDMOs for parenteral drug delivery. For complex parenteral drug products designed for systemic, targeted or localized delivery, we are uniquely positioned to serve as a global development partner and solutions provider. Our parenteral drug delivery portfolio includes th...
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    Must be taken with water or beverage of choice. 


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