GMP-Creative Biolabs provides one-stop customer-oriented services including biopharmaceutical contract R&D, process development, cGMP manufacturing, QA & QC solutions for scientific research, preclinical, clinical and commercial supply. We proceed your projects according to your specific demands in quality, timeline and budget, supporting researchers across different therapeutic areas. Clear, open and regular communication with customers is as important to our success as our in-depth scientific knowledge. more
With years of experiences in protein expression in different systems, Creative Biolabs understands the importance of size and aggregation analysis. Backed by our advanced instruments, we combine different analytic methods to analyze aggregates range from few nanometers to visible particles to complete your assay.
The aggregation of protein usually leads to protein misfolded，which is responsible for various diseases. Aggregates are more easily recognized by immune system which thereby cause more risky to trigger unnecessary immune response. ICH Q6B recommends the aggregates should be closely monitored since they significantly affect the drug stability and immunogenicity. While aggregates typically result in physical changes especially the protein size, the protein size analysis could be used as a practical method to monitor and detect aggregates conditions.
Creative Biolabs offers four solutions to help you verify protein size and aggregation.
AUC: analytical ultracentrifugation; SEC: size exclusion chromatography; CE-SDS: capillary-SDS electrophoresis; MALLS multi-angle laser light scattering.
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These four solutions have different appropriate conditions and a combination can be generated to obtain full information of protein aggregation.
Creative Biolabs proudly provides size and aggregation services about drugs and biotech products, we also help customers to establish and validate solutions on the guidelines of cGMP or GMP. Click here to see more details of our other services.
To discuss your Size and Aggregation demands or to request a proposal, please contact us by