Blue Stream's Method Development programs cover a range of activities which are collectively referred to as "Method Development Services." These Services may be conducted alone or in combination:

• Method Development
• Method Transfer
• Method Optimization

Blue Stream has in-depth expertise in developing analytical and potency methods for biologics and liposomal-formulated products that can be used at various stages of a product development cycle:

• Initial R&D/early product development characterization.
• Pre-clinical stage of product development, methods may be needed for both pre-clinical stability testing and CMC characterization. Of particular importance for the early stage is the development of good purity, stability-indicating, and potency/activity assays.
• Of critical importance in a cGMP environment are well-established and qualified assays which provide information on a product's safety, potency, identity, and purity. The crucial parameters may vary from one product to another based on functionality, formulation, and structural complexities.

Following the completion of Method Development activities, Blue Stream drafts a Client Test Method (CTM). The CTM is the property of the Sponsor, and is a product-specific SOP. It contains all method details including sample preparation, system suitability parameters, standards and controls, etc. The CTM is then used at Blue Stream for subsequent characterization and routine testing of Sponsor product.

All Method Development Services are accompanied by thorough laboratory record-keeping and documentation. As deliverables, the Sponsor receives Method Development, Method Transfer, or Method Optimization reports that detail laboratory activities, results, and conclusions.

The resulting method, if accompanied by a Sponsor-approved CTM, may be used for early-stage clinical product release.