The analysis of biologics like peptides, recombinant growth factors, hormones and antibodies is challenging due to the complex chemical structure of these molecules. As a result, method development requires a good understanding of the relevant quality attributes and application of appropriate analytical techniques.
Selvita offers the full analytical portfolio for the characterization of biotechnological products according to ICH-Q6B requirements including evaluation of physicochemical properties, biological activity, immunological properties, purity and quantity. This includes HPLC(-MS), cIEF, CE-SDS, ELISA, Bio- and Binding Assays, ELISA and a broad variety of compendial methods. Selvita features state-of-the-art instrumentation, including TFS QExactiveTM Plus OrbitrapTM MS; TFS TSQ AltisTM; Sciex CESI 8000 plus; TFS and Agilent HPLC/UHPLC (UV, CAD, ELSD, RID, FLD, MS); Biotechne iCE3, Agilent ICP-MS; AB QuantStudioTM 6 Flex RT-PCR System; GE Healthcare BiacoreTM T200; Biotek- and Tekan Multi-mode Microplate Readers etc.
Beginning with implementation and optimization steps, the required methods will be developed to a level that allows qualification/pre-validation and, finally, full cGMP validation. The process can be assisted by degradation and stability studies performed in our in-house stability chambers. After validation, the method can be applied for routine cGMP batch release at Selvita or transferred back to the client.
Throughout the whole process, our clients can benefit from the high level of experience of our experts who offer concrete support in terms of method adaption and streamlining.