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Antibodies Designed Just for You

HuCAL® Recombinant Monoclonal Antibody Generation Service

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

  • Production of three lots of antibody
  • Titration ELISA on the antigen material used for antibody selection
  • Reference lot determined
  • 20 x 50 µg vials of reference lot retained at -80⁰C for future comparisons
  • Deliverable: titration ELISA data and identification of reference lot
Fig. 2. An anti-drug antibody (ADA) bridging ELISA for five lots of Anti-Ipilimumab Antibody, clone AbD34429ia (HCA329); reference lot in green.

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

  • Titration ELISA for comparison of up to five antibody lots, including reference lot
  • Degree of deviation from the reference lot will depend on the assay format, antibody, and antigen reagents used
  • Deliverable: data to show the degree of deviation from the reference lot

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, Tm and Tonset

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.

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.

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).

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 Tonset and Tm of the protein (lower curve); Tonset, temperature at which the protein starts to unfold; Tm, unfolding transition temperature, the point at which 50% of the protein is unfolded.

Associated Topics