Baxter Pharmaceutical Solutions LLC

A review and discussion.Sterile products have several unique dosage form properties, such as freedom from microorganisms, freedom from pyrogens, freedom from particulates, and extremely high standards of purity and quality; however, the ultimate goal in the manufacture of a sterile product is absolute absence of microbial contamination.The emphasis of this article will be the validation of the sterilization processes responsible for achieving this goal.Historically, judgment of sterility has relied on an official compendial sterility test; however, end-product sterility testing suffers from a myriad of limitations.Validation of sterile products in the context of this article will refer to the confirmation that a product has been exposed to the appropriate manufacturing processes and especially to the appropriate sterilization method yielding a batch of product having a known degree of nonsterility.

A review.A case study of the anal. development of an early-phase protein pharmaceutical is presented.Anal. method development was required not only for support of early formulation development, but also for early stability studies and for final release assays.Methods based on seven different techniques were developed for support of formulation development and for validation as product release assays.These techniques included sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE), UV-Vis, isoelec. focusing, anion-exchange chromatog., reverse-phase chromatog., size-exclusion chromatog., and Western blot.