PAT: 將品質融入生物製藥流程
具備即時監控功能
製程分析技術 (PAT) 可透過即時監控製程來確保生物製藥的品質。它利用分析工具來開發製程,以適應材料和設備的多變性。一旦確定影響關鍵品質屬性 (CQAs) 的關鍵製程參數 (CPP),就會使用分析方法來監控 CPP,使其維持在所需的設計空間內。這種方法將品質設計 (QbD) 原則整合到製程中,而不是僅僅依賴最終的產品測試。
線上與即時拉曼監測
拉曼光譜是 PAT 實施中使用的眾多工具之一。 這種光學分析技術可通過其獨特的指紋識別分子,非常適合生物製藥過程:由於其分子特異性高,且受水的干擾最小,因此即使在複雜的生物製藥水溶液中,也能同時監測多個參數。拉曼光譜能以非破壞性和可重現的方式測定化學成分和分子結構,消除了因降解、不穩定性或樣品製備而遺失化學資訊的風險。例如,此技術可用於監測細胞培養的 CPPs,如葡萄糖、乳酸、細胞密度和氨,以及 CQAs,例如蛋白滴度、糖基化和聚集。拉曼技術可以實現製程的即時監控和自動化,也不需要收集樣品送至品質控制 (QC) 實驗室進行分析。
拉曼技術可以實現製程的即時監控和自動化,也不需要收集樣品送至品質控制 (QC) 實驗室進行分析。
與傳統的離線分析方法(如細胞培養多重測試分析儀、細胞存活率分析儀或 HPLC)相比,拉曼光譜法在上游 (USP) 和下游 (DSP) 製程中都有明顯的優勢,包括:
- 拉曼光譜法可以在任何製程中使用:
ProCellics™ 拉曼分析儀是專為生物製程產業設計的簡單易用的製程分析技術 (PAT) 平台,用於監控 USP 和 DSP 生物製程,從製程開發到製造,進行定性和定量分析。此外,與手動取樣相比,該平台有助於節省時間、提供操作員靈活性,並降低污染風險和批次失敗。 因此,它使用戶能夠自信地駕馭細胞培養製程。
ProCellics™拉曼分析儀有兩種配置,可完全適應製造要求,滿足從製程開發到製造的一系列監測需求:
單通道裝置可使用一個探針監測培養物。該套件包括一個配備 785 nm 雷射的基本裝置、一個探針、配件,以及一台包含 Bio4C® PAT 拉曼軟體的多合一電腦。
多通道裝置可在相同的系統佔用空間內同時監測多達四個培養物。該套件包括一個配備 785 nm 雷射的基本單元、一個配備四個探針的多通道單元、配件,以及一台包含 Bio4C® PAT 拉曼軟體的多合一電腦。
先進的探針管,結合特定的軟體功能,可抵消光線干擾的影響,無需遮蔽生物反應器以避免光線照射。
它強化了拉曼技術在各種單元操作中的可擴展性,允許從單次使用系統無縫轉換到多次使用系統,以及從製程開發到生產製造之間的不同規模。
相關類別
我們的現成與客製化生物製程細胞培養基 (CCM) 產品可提升上游 mAb、疫苗、基因/細胞治療製程的生產力。
Mobius®生物反應器系列包括工作台規模(2 mL 和 3 L)、中試、臨床和...
利用我們的細胞保留解決方案,增進灌注種子列的效率。即時監控。
相關資源
- Datasheet: ProCellics™ Raman Analyzer with Bio4C® PAT Raman Software
Specifically designed for the bioprocessing industry, ProCellics™ Raman Analyzer with Bio4C® PAT Raman Software enables you to perform in-line and real-time measurement of CPPs and CQAs, from process development to manufacturing.
- Application Note: Enabling accelerated Raman model calibration for seamless and reproducible real-time monitoring by combining Raman and automated sampling technologies
Explore how automated sampling can accelerate the integration of a Raman analyzer for a bioreactor application, speeding up the Raman model building phase, and facilitating in-line, real-time monitoring of critical process parameters (CPPs) and critical quality attributes (CQAs) during the manufacturing process.
- Application Note: Monitoring bioprocesses in a light environment using Raman spectroscopy
This application note introduces an advanced solution to facilitate the implementation of Raman technology in laboratory and manufacturing scales, in a normal light environment, to ensure the consistent monitoring of critical process parameters (CPPs) and critical quality attributes (CQAs).
- Application Note: An innovative approach to streamline Raman implementation for cell culture processes: One-batch calibration
This novel modeling approach eliminates the need for multiple calibration batches during the Raman implementation, allowing for a more streamlined and efficient workflow.
- Application Note: Real-time and in-line Raman Spectroscopy: A Window into Glycosylation Quality Analysis
This case study demonstrates the effectiveness of Raman technology for monitoring monoclonal antibody (mAb) glycan profiles during fed-batch processes, and how robust predictive models facilitate monitoring of glycosylation profiles.
- Application Note: In-line Real-time Monitoring of CHO Cell Culture Process Parameters Using Raman Spectroscopy
Cell culture processes are complex and highly variable and yet only a handful of key parameters such as temperature, pH, and dissolved oxygen (DO) are typically controlled in real time.
- Application Note: Implementation of Raman Spectroscopy for In-line Monitoring of CPPs of CHO Cell Perfusion Cultures
This application note introduces a case study for the implementation of a Raman spectroscopy soft-sensor for in-line and real-time monitoring of critical process parameters (CPP) in mammalian perfusion cell cultures.
- Application Note: Seamless Integration of Glucose Control Using Raman Spectroscopy in CHO Cell Cultures
Process analytical technology (PAT) and quality by design (QbD) are used in the biopharmaceutical industry to ensure quality is designed into a process and to achieve innovative quality improvements.
- Application Note: Cell-free modelling approach for efficient cell culture monitoring using Raman spectroscopy
The novel synthetic model approach provides a significative gain of time and resources for the Raman calibration phase which is reduced to just a few days.
- One-Batch Calibration: A Process-, Instrument-, Scale- & Site-agnostic Method For Streamlining Raman Implementation
Challenges associated with Raman spectroscopy implementation in bioprocesses can be overcome by the innovative one-batch calibration approach. This streamlined process requires less time and resources compared to traditional approaches, unlocking Raman benefits for biopharmaceutical applications.
相關網路研討會
利用拉曼光譜監測灌注中的 CPP 和 CQA。
探索使用拉曼光譜技術對細胞培養基製備進行品質控制的可能性
利用自動化無菌採樣加速上游生物製程中製程和品質資料的獲取。
探索線上 HPLC 在生物製程中監測和控制抗體聚集水平的效用。
BioContinuum™平台:您未來生物製造設備的推手!
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