【產品手冊｜Bioassays for Biologics 大分子藥物篩選工具庫】

                           Promega Biologics Portfolio  

專為Antibody-Based Biologics所設計的Functional Analysis！

因應免疫療法開發之需求，Promega團隊在產品開發的過程中對Biological研究與發展持續的關注與了解，積極的與全球各學者、藥廠合作，並與許多藥物開發單位的研發人員密切交流，確保這些Bioassay符合並滿足所有使用者的需求，並專為熱門大分子& ADC藥物篩選，設計出全系列Functional bioassay！


●推出六大類可供藥物開發Biological functions相關檢測方式！加速新藥開發時程：​
■Fc effector activity(ADCC,ADCP,PBMC ADCC, FcrRIIb bioassay & Fc Receptor binding immunoassays)​
■Viral vaccine development​
■Immune checkpoint modulation(PD-1/PD-L1,CTLA-4,LAG-3/MHCII,TIGIT/CD155…或OX40,CD40,GITR, 4-1BB)& Combination immunotherapy (PD+TIGIT and others)​
■T-cell activation ( TCRαβ knock-out, TDCC)​
■Cytokine and growth factor signaling​
■Antibody drug conjugated (ADC)相關工具​

●依據ICH guideline要求，可以作下列應用：​
✓ Assay可反映Biologics Drug的真實MOA​
✓ Well-controlled: precise, accurate, robust, reproducible​
✓ Usable for potency determination​
✓ Stability-indicating​
✓ Suitable for validation as a QC lot-release assay​
✓ 已廣泛應用於藥廠生產製程當中​
✓ Cell as reagent, 解凍即用, 無須額外培養​
業界唯一符合Regulatory Authority的審查要求！​
可加速前期藥物快篩、中期QC-lot release& stability測試及後期臨床試驗申請時程，強化實驗數據可信度&效度！