mAb 產品特性

當您的單株抗體 (mAb) 從概念走向臨床時，選擇合適的合作夥伴提供產品表徵服務至關重要。我們與您合作以降低開發和製造過程的風險，在關鍵時刻加速產品品質的決策。

預先配置的現成檢測套件，旨在加速獲得可操作數據的時間

我們的全面性計畫揭示了您的分子在開發過程中每個階段的真實身份，確保您的生物療法的安全性、純度和效力。您可以選擇我們以 mAb 為基礎的檢測套件，或是為您的生物製劑量身打造的客製化檢測。

• 批次釋放與穩定性 
• 製程與產品雜質

若要討論您的專門需求，並採取下一步以確保您生物療法的未來， 請聯絡我們的產品特性專家。

具有專業知識的適應性合作夥伴

為了協助您將安全的新療法推向市場，BioReliance^®測試服務提供廣泛的生物療法表征、安全性測試和流程開發組合，涵蓋從藥物發現到上市核准的每一個開發步驟。我們經驗豐富的團隊搭配我們的營運專業知識和對法規的深入瞭解，可協助您在流程的每個步驟中將風險降到最低。

相關產品資源

Webinar：透過產品特性化降低風險
網路研討會：製程雜質：別讓 PEI 或 HCP 毀了您的生物治療

索取資訊

。

以 * 標示的欄位為必填欄位。

相關影片

Slide 1 of 4

Biotherapy Characterization: Cell-Based Assays

Senior Scientist, Agata Burzawa, MSc, describes how designing cell-based assays to help our clients understand the complex biological functions of the therapy they are developing as a part of product characterization.

Biotherapy Characterization: Binding Assays

Senior Scientist Helen Hsu, Ph.D. describes how, with our custom binding assays, and supported with our comprehensive off-the-shelf Fc gamma receptor binding assays, we can help you optimize your mAb production, from clone development through upstream and downstream processes.

Explore What's Next in Product Characterization

The complexities of biological manufacturing, the large size of the molecules, and the product heterogeneity introduced by cellular expression systems present significant challenges to measuring the quality of a biologic drug. Newer, high-resolution analytical techniques help answer questions regarding product heterogeneity and drug functions, and help assess for product-related aggregates and impurities.

Understanding Cytokine Activation

Product Characterization Scientist, Rachel Wood, introduces the multiplexed cytokine release assay. A highly sensitive assay that requires low sample volumes to measure the cytokine release activity induced by your mAb.