BIOMEVA's analytical service department provides full services for batch release testing and stability testing of APIs. Analytical Services can assist clients in determining which assays are best suited for their biological drug substance, as well as in developing new methods if required.
BIOMEVA's analytical laboratories are fully compliant with cGMP regulations. All relevant documents are subject to the BIOMEVA document control system administered by Quality Assurance (QC).
Batch Release Testing
BIOMEVA's batch release testing program aims to speed up this process while providing clients with fully validated assays performed in compliance with cGMP. The company's program also includes customized submission, assay start date reservations and concise reporting.
BIOMEVA's stability testing protocols of a biological drug substance meet the requirements as outlined by ICH. In addition, BIOMEVA can provide custom stability testing protocols to fulfill the specific requirements of individual manufacturers. These stability testing protocols provide real-time, real-condition stability data as well as accelerated or stress data if needed.