PHARMACEUTICAL AND DRUG PRODUCTS MANUFACTURING

Preclinical Manufacturing Support

Cirrus can manufacture drug products for all preclinical studies including GLP-toxicology support. A variety of dosage forms can be manufactured on site including, solutions, suspensions, emulsions, dry powders, capsules, tablets, semi-solids, colloidal dispersions, lyophilized products for all routes of administration, as applicable.

Clinical and Commercial Manufacturing Support

Cirrus makes the transition to clinical manufacturing fairly seamless for the client. As needed, we assist with identifying an appropriate clinical/commercial manufacturing facility for the specific drug product. Cirrus would develop a scalable process, prepare pilot scale batches and establish drug product specifications. In preparation for the technical transfer to the manufacturing site, our staff can write and QA review the manufacturing monograph and batch records. If desired, Cirrus scientists can oversee subcontracted clinical manufacturing and commercial batch manufacture to help ensure a smooth transition. To complete technology transfer, Cirrus can perform in-process testing and comparability studies.

Release and Stability Testing of Drug Product

Batch release (GLP and cGMP) for preclinical and clinical supplies as well as commercial products can be performed at Cirrus. Additionally, release testing for raw materials and packaging materials can be performed as per specific pharmacopeial guidelines.
Long-term stability testing at intended and accelerated storage temperatures can be performed at Cirrus as per ICH guidelines for clinical and commercial batches. Fully validated stability chambers are available for storage at a variety of temperature and humidity conditions. Analytical method validation services for release and stability testing are also provided by Cirrus.

Packaging Components Selection for Drug Product

Cirrus assists in evaluating and selecting packaging components for clinical batches and commercial product. Packaging components (e.g., canisters, valves, actuators, IV bags, etc.) are selected based on product design criteria, performance evaluations and potential formulation interactions. Moisture protective overwraps, dose counters and other customized components can be incorporated into the product and evaluated as requested. Extractables and Leachables services provided by Cirrus assist in selection and qualification of appropriate primary and secondary packaging components compatible with the drug product and applicable for the intended route of administration.

 

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