Coldstream Laboratories specializes in the development and manufacture of potent drug products.
We employ state-of-the-art mobile isolator technology in our manufacturing facility to provide a physical barrier that protects our staff from toxic substances and encloses your product in an ISO Class 5 Environment. Similar fixed isolators are used our development labs to mimic manufacturing operations and enable formulation and analytical development on toxic substances. Through the use of these high containment “glove boxes” our scientists create and maintain a controlled sterile envelope that enables us to process potent drug classes including cytotoxins, steroids, hormones and acutely toxic substances.
Additionally, Coldstream can assist our clients in evaluating the hazards associated with their compounds through our New Product Assessment program to determine an Occupational Exposure Limit (OEL). The OEL value is used to establish cleaning and containment strategies for the drug during manufacturing operations. Our operating systems require that all direct product contact equipment is either dedicated or disposable in order to provide robust protection against cross-contamination.
Coldstream’s facilities and skilled team of experts can help you safely and efficiently turn your high-potency project into a success. We specialize in formulating highly toxic compounds into safe and effective drug products.