Extended Quality Control Services

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Tel: +49 (0) 89 80 90 95 45
Fax: +49 (0) 89 80 90 95 50
Office: Bio-Rad AbD Serotec GmbH, Campus Neuried, Anna-Sigmund-Str. 5, 82061 Neuried, Germany

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We understand that an antibody for use as a critical reagent in clinical studies, or as a raw material in a regulated IVD test, needs to be well characterized and of consistent quality.

Our extended quality control (QC) services are available for recombinant antibodies made as part of a custom HuCAL^® project. They provide data to enable lot-to-lot comparison, and assist selection of the most appropriate antibody clone for your assay requirements.

Reference Lot

• Development of a reference lot of antibody
• Comparison of a new lot of antibody with the reference lot

Testing of each newly produced lot of an antibody in comparison with the reference material, and delivery of data showing degree of deviation from the reference lot; provides knowledge of the lot-to-lot consistency of the clone when ordering over months or years.

Stability

• Freeze-thaw test
• Accelerated stability test
• Determination of antibody melting temperature

Tests to provide characterization data for an antibody and enable comparison between different clones of the same specificity, assisting selection of the best clone for the assay.

Reference Lot Determination and Comparison

Fig. 1. Specificity titration ELISA for three lots of
Anti-Ipilimumab Antibody, clone AbD34433 (HCA330).

Fig. 2. An anti-drug antibody (ADA) bridging ELISA for five lots of Anti-Ipilimumab Antibody, clone AbD34429ia (HCA329); reference lot in green.

Extended Stability Package

• Freeze-thaw: ten freeze-thaw cycles followed by functional assay
• Accelerated stability test: three temperatures over four weeks, comparison to control in functional assay
• Determination of antibody melting temperatures, T_m and T_onset

The package of services is available for Fab antibodies and purified full length immunoglobulin formats for all IgG isotypes, IgA, and IgE. Freeze-thaw testing and a shorter accelerated stability study are also available separately as individual assays.

Freeze-Thaw Test

Fig. 3. An ADA bridging ELISA for Anti-Ustekinumab Antibody AbD17827_hIgG1 (HCA210), after the indicated freeze-thaw cycles. The data show the antibody withstands a minimum of ten freeze-thaw cycles without any loss of activity.

Accelerated Stability Test 

Fig. 4. Accelerated stability testing of one lot of one antibody at three temperatures over four weeks comparison with control stored at -80°C. ADA bridging ELISA for Anti-Ustekinumab Antibody AbD17827_hIgG1 (HCA210); EC₅₀ values were calculated from the nonlinear curve fits.

Thermal Stability 

Fig. 5. Thermal stability of Anti-Ustekinumab Antibody clone AbD17827_hIgG1 (HCA210). A350/330 nm ratiometric measurement of the fluorescent signal plotted against temperature (upper curve) and determination of T_onset and T_m of the protein (lower curve); T_onset, temperature at which the protein starts to unfold; T_m, unfolding transition temperature, the point at which 50% of the protein is unfolded.

Resources

Five Ways to Control Your Critical
Antibody Reagents and Avoid Bioanalytical
Assay Failure  

Learn how to secure high quality, reproducible and
sustainable critical antibody reagents early in the
development lifecycle.

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Associated Topics