Simply put, orthogonal validation uses additional methods that provide very different selectivity to the primary method to confirm or refute a finding. All methods are independent approaches that can ...

Refeyn, the company behind pioneering mass photometry technology, announces that mass photometry has been recognized by the U.S. Pharmacopeia (USP)—and referenced in the new draft USP general chapter ...

The terms “process-specific” and “generic” are commonly used in scientific publications and regulatory guidelines in reference to host cell protein (HCP) analysis of recombinant biopharmaceuticals.

Subvisible particulate matter is under increasing amounts of scrutiny in the field of parenteral and ophthalmic drug products. USP <1788> and <1788.3> explicitly recommend the use of flow imaging and ...