Protein Sciences

A: Typically, we only need a small amount of antibody for each assay. For AC-SINS, we need ~10-15 micrograms depending on the incubation concentration and the number of duplicates required.

A: We typically use mouse and cyno serum for human drugs. Of course, we can also develop customized serum based on our clients’ needs.

A: Yes, of course. Most of our clients choose the full package, but some clients have a good understanding of their molecule and select a few specific assays from our package.

A: Our micro developability assays are conducted on early-stage molecules. As such, the formulation study and other comprehensive studies are performed after this panel of assays.

A: Our data is quite consistent with published data.

A: Most clients want to know low pH, but some clients ask us to perform the high pH hold. We can customize our testing based on clients’ needs and can perform high pH upon request.

A: It means that before the 40°C stress there’s some population distribution of the main species, acidic species, and the basic species. After the high-temperature stress, the population distribution changes slightly, because of the charge changes.

A: In this assay, we have a control sample. This sample is a mixture of serum and target protein but isn’t incubated. By comparing the control, degradation caused by the stress of capture/elute can be excluded.

A: We start by looking at the molecule’s sequence and determine whether there are opportunities to optimize its profile. If we can engineer the sequence, we may use the wet lab assays to verify the molecule again.

A: Yes. The algorithm works for many kinds of proteins. We can perform in silico analysis for all of them.

A: Typically, it’s about 100 molecules. However, we can easily accommodate more.

A: It’s a proprietary algorithm developed based on the solvent-accessible surface region of the hydrophobicity residues and the existence of free cysteine residue from the structural information.

A: We can do it either way. Our clients can come to us with existing molecules, or our Protein Sciences Department can produce the protein from a sequence.

A: We have three categories of algorithms: 1) Sequence liability, 2) aggregation propensity, 3) and immunogenicity prediction. Sequence liability is an open-sourced algorithm for post-translational modifications (PTMs) prediction. We assessed liability because PTMs on the CDR regions may affect antigen-binding. Regarding aggregation propensity prediction, the results would indicate high/medium/low aggregation based on the solvent-accessible surface region of the hydrophobicity residues and the existence of free cysteine residue. However, the formation of protein aggregates is influenced by multiple factors (e.g., solvent micro-environment, solvent concentration, storage time, and condition), and the prediction can only reflect the effect of hydrophobicity and/or unwanted disulfide bond formation. For the last immunogenicity prediction, our results show a ~0.6 correlation between ADA generation and our prediction using publicly assessable data.

A: We can perform most of our PK-predicting assays in two weeks. The time it takes to conduct forced degradation studies depends on the desired conditions (e.g., the number of days to incubate your sample). After we finish the experiment, it typically takes a week to produce the final report.

A: The purposes of early- and late-stage packages are different. The early-stage package is used to predict risks and provide guidance to optimize the molecule. The late-stage package is used to investigate the molecule’s properties (which is typically already optimized in the early stage).

A: Yes, of course. We can accommodate any specific requirements you have for your project.