Analytical Development and Qualification

Analytical development and qualification services for live biotherapeutic products (LBPs)** are critical components in the development and manufacturing of these innovative therapies. LBPs, which include live microorganisms such as bacteria used for the treatment or prevention of diseases, require rigorous analytical procedures to ensure their quality, safety, and efficacy.

Analytical development involves creating and optimizing test methods to characterize these products, focusing on aspects like identity, potency, purity, viability, and stability of the microorganisms. This process often includes developing assays for microbiological testing, genetic sequencing, and assessing the mechanism of action of the live biotherapeutic organisms.

Qualification services ensure that these analytical methods are suitable for their intended purpose, providing accurate and consistent results. This involves validation processes to confirm that the methods meet regulatory requirements and are robust enough for routine use in quality control and lot release.

Together, these services ensure that live biotherapeutic products are thoroughly tested and verified, facilitating regulatory approval and ensuring patient safety. As the field of microbiome-based therapies continues to grow, these analytical services will remain indispensable in bringing effective LBPs to market.