Save your stability Program! - Out of Specifications impurity in Biotech NCE/NBE stability

Tox by Design has developed a new approach to requalify Out of Specifications ("OOS") impurities (ICH Q3A/B, Pharmacopeia) by leveraging ICH M7 new regulation options to improve this impurity specification limit.

💊 Any chemical impurities discovered during the development of a new chemical or biological entity have to be qualified.

The guidance for identification, categorization, qualification and control of impurities is provided by the ICH guidelines Q3A/B, Q6 A/B, M3 and M7.

Tox by Design offers a range of toxicological expertise to ensure the safety and quality of your pharmaceutical and biotech products.

🥼 Our pure player expert toxicological team offers assistance to biotech companies during the industrial GMP scale up of New Chemical Entities and New Biological Entities following ICH guidelines through toxicological risk assessment and evaluation.

💪 In particular, Tox by Design has developed a new approach to requalify Out of Specifications ("OOS") impurities by leveraging ICH M7 in the following cases:

• First case: New drug substances or drug products during clinical development or subsequent marketing application

• Second case: Post approval submission of marketed products, new marketing applications for products with a drug substance that is present in a previously approved product in both cases, but only where:

  1. Changes to the drug substance synthesis result in new impurities or increased acceptance criteria for existing impurities.

  2. Changes in the formulation, composition or manufacturing process result in new degradation products or increased acceptance criteria for existing degradation products.

  3. Changes in indication or dosing regimen are made which significantly affect the acceptable cancer risk level.

👉 Visit our website https://toxby.design to learn more about our innovative methodology for improving OOS specification limit