Releasing Your Biologic Into Russia?
An increasing number of pharmaceutical companies are being requested by Russia’s regulatory authorities to perform in vivo testing prior to releasing batches into its market. In order to answer these requests, Charles River has developed several assays that comply with protocols described in the Russian Pharmacopoeia. These tests are performed in a GMP environment and are checked and released by our Qualified Person before the final report is sent to the customer.
Russian Pharmacopoeia compliant assays include:
Abnormal toxicity tests:
Testing is carried out on groups of 5 mice or 5 mice + 2 guinea pigs (SPF status), according to your product’s specificities. Our technicians are trained for all methods of injection (e.g., IV, IM, SC, IP).
Tests are performed on non-albino rabbits (Chinchilla Bastard rabbits, SPF status) as requested by the Russian Pharmacopoeia. Testing uses qualified software for continuous temperature recording.
Biological studies for insulin:
Biological methods for insulin testing are based on the comparison of the hypoglycemic action of the test product with the hypoglycemic action of an insulin reference standard. Several methods can be used to assess different quality parameters including biological activity, biologics similarity, and prolonged action.
Currently available methods from Charles River include:
- Prolonged action of insulin products – performed on New Zealand White rabbits (SPF status)
- Determination of biological activity of insulin and its analogues by a decrease in blood glucose concentration in rabbits – performed on Chinchilla Bastard rabbits (SPF status)
The glucose dosage for both tests is performed on rabbits’ sera on-site via a validated method using the Glucose Liquicolor® kit.
If you receive testing requests from Russian authorities for your products, Charles River can evaluate the development of these and other assays described in the Russian Pharmacopoeia. Contact us at [email protected] for additional information.