What We Offer
Contract Manufacturing
We specialize in the manufacture of radiolabeled, potent and cytotoxic products. Isolator technology enables us to provide ISO class 5 processing and containment.Lyophilization
Coldstream’s team of experts can assist you in all stages from development/optimization of a lyophilization cycle through small-scale commercial manufacturing of commercial lyo products.Analytical Development
Strong analytical methods are key to a successful FDA filing. From transfer of existing methods to complex method development, Coldstream has the custom solutions for your specific project.Formulation Development
Targeted product design is carried out by our experienced scientists at Coldstream Laboratories. No matter what your drug product needs may be, our 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 you need for your parenteral product.
Coldstream Labs.
Coldstream Laboratories is your outsourcing partner for pharmaceutical development and aseptic and non-aseptic drug product 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-approved sterile manufacturing facility ensures product containment for potent and cytotoxic compounds and radiolabeled products. 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. Contact us today to learn more about Coldstream Laboratories.Learn More »