With years of experience 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 ranging from a few nanometers to visible particles to complete your assay.
The aggregation of protein usually leads to protein misfolding, which is responsible for various diseases. Aggregates are more easily recognized by immune system, which thereby cause a higher risk to trigger unnecessary immune responses. 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.
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Methods
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Size range
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Sensitive
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Robust
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Resolution
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Quantification
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Combining
Online detector
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AUC
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1nm-100nm
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-
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SEC
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1nm-50nm
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√
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CE-SDS
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kDa-MDa
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√
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MALLS
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kDa-MDa
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√
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AUC: analytical ultracentrifugation; SEC: size exclusion chromatography; CE-SDS: capillary-SDS electrophoresis; MALLS multi-angle laser light scattering.
represents limited represents medium represents good
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.
For Research Use Only. Not For Clinical Use.
