CLEAR
當發展出用作開發生物相似劑的細胞後，製造商會仔細分析細胞所生產出來的分子，並將其關鍵質量屬性與參考生物製劑進行特性比較。關鍵質量屬性對藥物的安全性、藥效、藥物動力學和整體品質有著重要影響 。1,2
生物製劑難以大量生產，因為在製造過程中，環境因素非常重要，溫度和酸鹼值等的輕微變化都足以令藥物變質 。3,4 因此，製造商必須嚴謹監控產品開發的每個步驟，確保藥物的純度、穩定性和藥效達標。只有藥物品質獲得認證，方可進行包裝對外供應。 5
製藥過程中出現的問題或阻礙都可能延誤藥物供應。因此，製造商須與監管機構緊密聯繫，並全面掌握策劃及生產過程，將藥物短缺和供應中斷的風險減到最低。3
“安進可維持優質生物製劑的穩定供應，全賴對患者堅定的承諾、專業知識、先進的設施，並時刻投入資源優化工序。 ”
研製生物相似劑需利用活細胞，並經過多重複雜精細的步驟。然而，生產參考藥物的細胞種類及製造程序由原製藥公司專利擁有，其他製藥公司只能夠透過多次活性對照試驗及實驗，對參考藥物作出比較，從而評估其抗體的生物相似性。透過採購並分析不同批次的參考藥物，有助為日後的結構及功能生物相似性測試建立評估基準。4,6-8
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