Over 40 years’ worth of know-how in long-term management of critical reagents.
Agro-Bio offers secure storage and stability studies for critical reagents used in bioanalytical methods (immunogenicity, pharmacokinetics (PK)), and HCP kits.
Together we define a tailored protocol, including:
Regulatory guidelines recommend paying particular attention to the management of these critical reagents: “the sponsor should appropriately characterize and document [...] critical reagents, such as antibodies […].” - (1) Source: Bioanalytical method validation, Guidance for industry; May 2018; Food and Drug Administration (FDA).
(1) The excerpt in full: “The sponsor should appropriately characterize and document (e.g. determine the identity, purity, and stability) all reference standards and critical reagents, such as antibodies, labeled analytes, and matrices and store them under defined conditions.”