New technique, in combination with the use of artificial intelligence, allows fragments of antibodies to be screened for susceptibility to aggregation caused by structure disruption much earlier in the drug discovery process. Protein/Antibody therapies can be highly effective in treating disease. The failure rate of protein candidates upon manufacturing at industrial scale is a significant problem, emerging in the late stage of development process. With the protein/antibody sequence information gathered into our database and getting bigger, the screening system is underdeveloped using AI methods. Protheragen's AI platform has a range of proteins to screen and to determine which are more likely to progress through the development process.
FDA has announcing the availability of a final guidance for industry entitled “Immunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody Detection.” Immunogenicity is the intrinsic capacity of a product to induce an immune response in a target population. Immunogenicity testing assays provide a way to measure the potential immune responses of biologics and biosimilars.
Figure 1 Potential Causes of Immunogenicity
Whole PBMC/DC activation – impact of proteins and impurities
MAPPs (MHC-Associated Peptide Proteomics)
T cell activation assays (native and memory)
Impact of mode of action
Experts from Protheragen are dedicated to helping researchers and pharmaceutical companies to identify patterns in protein sequences, and inform our clients whether a drug can be scaled up for production.
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