Analytical Program Design
The cornerstone of any product development effort is the analytical characterization and validation of all raw materials, bulk solutions, in-process materials, and finished product. Althea’s well-designed analytical programs satisfy regulatory requirements and work to assure the success of the clinical program. Analytical Scientists customize phase-appropriate analytical programs to the specific needs of your unique molecule delivering a comprehensive understanding and characterization of the molecule for each stage of development and commercialization.
You can then make process changes necessary for successful formulation, drug delivery, and vial to syringe fill finish. As your drug product advances through the clinic, we will design and execute analytical programs that support a full characterization of the drug product.
Reference lots or standards are incorporated throughout the analytical program and are utilized as controls for assays used during the development and characterization of your product. Every time your drug product is manufactured, we compare your drug product against the standard to ensure it has comparable quality, purity, strength, and consistency.