Stability studies and storage

Over 40 years’ worth of know-how in long-term management of critical reagents.

Stability studies and storage of your reagents and antibodies

Agro-Bio offers secured storage and stability assement of all your critical reagents used in bioanalytical methods (immunogenicity, pharmacokinetics (PK)), and HCP kits. 

Together we define a custom protocol, including: 

  • the parameters to test
  • the retest frequency
  • the storage conditions

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.”

Top

Biopharma

  • Audit & confidentiality agreement
  • Traceability
  • Ensuring compliance with authority regulatory requirements
  • Quality control