• Contract Manufacturing

    We specialize in small volume parenteral manufacturing for liquid and lyophilized products. Isolator technology provides ISO class 5 processing and containment for sterile fill/finish of potent and cytotoxic products.                                                                    
  • Lyophilization

    Coldstream's team of experts can assist you in all stages from lyophilization development or lyocycle optimization through commercial manufacturing of small-scale lyophilized products.

  • Analytical Development

    Strong analytical methods are key to a successful FDA filing. From transfer of existing methods to complex analytical method development, Coldstream has the custom solutions to support your specific project.
  • Formulation Development

    Targeted product design and process development is carried out by our experienced scientists at Coldstream Laboratories. No matter what your drug product needs may be, our experienced team can help you accelerate your project's path to the market!
  • Microbiology Services

    Proof of integrity is paramount in the pharmaceutical industry from facility validation to finished product sterility. Enlist Coldstream to assist you with the microbiology testing you need for your parenteral product.

Contact Us:

Coldstream Laboratories is your outsourcing partner for pharmaceutical development and small-volume parenteral manufacturing services. We combine individualized service with unparalleled speed and flexibility to develop and manufacture parenteral drug products in liquid and lyophilized dosage forms. Unique mobile isolator technology within our FDA-inspected sterile manufacturing facility ensures product containment for potent and cytotoxic compounds. Our highly skilled staff supports all aspects of the drug development process, including analytical chemistry and pre-formulation / formulation development services. Our onsite microbiology lab offers method validation and routine micro testing services, either in conjunction with manufacturing activities or as standalone services. Together with the Piramal facility located in Grangemouth, Scotland, we offer an integrated solution for antibody drug conjugates (ADCs). Contact us today to learn more about Coldstream Laboratories.

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