过程分析技术（PAT）通过实时监测和控制生产过程，确保生物制药生产的质量。该技术运用分析工具开发制造工艺，以适应物料和设备的变异性。 在识别出影响关键质量属性（CQAs）的关键工艺参数（CPPs）后，通过分析方法对CPPs进行监测与控制，使其维持在预设的设计空间内。这种方法将质量源于设计（QbD）原则融入生产过程，而非仅依赖最终产品检测。
在线和实时拉曼监测
拉曼光谱是过程分析技术（PAT）应用中的众多工具之一。这种光学分析技术通过分子独特的指纹特征进行识别，特别适用于生物制药工艺：凭借其高分子特异性及对水干扰极小的特性，即使在复杂的水性生物制药溶液中，也能同时监测多个参数。 拉曼光谱技术能够以非破坏性且可重复的方式确定化学成分和分子结构，避免因降解、不稳定或样品制备导致化学信息丢失的风险。例如，该技术可用于监测细胞培养中的CPPs（如葡萄糖、乳酸、细胞密度和氨）以及CQAs（如蛋白质滴度、糖基化及聚集）。 分析过程通过将探头与其他常用传感器共同插入工艺流程实现，从而使拉曼技术能够进行实时监测和自动化控制，同时免除向质量控制实验室送检样本的环节。但若用户有特殊需求或工艺配置要求，该技术亦可提供在线、在线旁或离线测量模式。
相较于细胞培养多联试分析仪、细胞活力分析仪或高效液相色谱等传统离线分析方法，拉曼光谱技术在上游制备（USP）与下游制剂（DSP）工艺中均具备显著优势，包括：
- 单探头实现多属性监测
- 在细胞培养过程中实施自动进样策略
- 单光谱即可获取完整的化学与生物信息
- 支持实时原位测量
- 非破坏性分析
- 可根据需求灵活采用在线探头或在线/在线旁/离线模式轻松实施
ProCellics™拉曼分析仪专为生物加工行业设计，是一款易于使用的过程分析技术（PAT）平台，用于监测从工艺开发到生产的USP和DSP生物加工过程，实现定性与定量分析。
该平台能深化工艺理解，助力实施自动化过程控制策略。相较于人工采样，它可显著节省时间、提升操作灵活性，同时降低污染风险和批次失效率。由此赋能用户，使其能够自信地驾驭细胞培养工艺。
ProCellics™ 拉曼分析仪提供两种配置方案，可完全适应生产需求，满足从工艺开发到生产制造的全方位监测需求：
单通道设备支持单探头培养物监测。套装包含：配备785 nm激光器的基座单元、单探头、配件以及内置Bio4C® PAT拉曼软件的一体化计算机。
多通道单元可在同一系统占地范围内实现最多四个培养物的并行监测。该套装包含配备785纳米激光器的基座单元、带四个探针的多通道单元、各类配件以及内置Bio4C® PAT拉曼软件的一体化计算机。
通过先进探针管与特定软件功能的结合，可有效抵消光干扰效应，从而无需对生物反应器进行遮光处理。
该技术增强了拉曼技术在各类单元操作中的可扩展性，实现从一次性系统到多用途系统的无缝过渡，并支持工艺开发与生产制造阶段不同规模的灵活转换。
相关分类
我们的现成可定制生物加工细胞培养基（CCM）产品，可提升单克隆抗体、疫苗、基因/细胞疗法等上游工艺的生产效率。
Mobius®生物反应器系列包括台式规模（2毫升和3升）、中试规模、临床规模以及...
采用我们的细胞保留解决方案，提升灌注种子列的效率。实时监测与控制。
相关资源
- Article: Direct Upstream Monitoring with Raman Ready-to-Use Models
Learn how Raman ready-to-use models simplify calibration and allow real-time monitoring of CPPs and CQAs in upstream processes - no custom calibration required. See results from upstream and downstream runs and how transfer learning can fine-tune model accuracy after a single batch.
- Application Note: In-Line Monitoring of CPPs and Capsid Titer in Upstream AAV Process with ProCellics™ Raman Analyzer
Explore the ProCellics™ Raman Analyzer for in-line monitoring of critical process parameters (CPPs) and capsid titer during AAV production in Human Embryonic Kidney (HEK) cell bioreactors.
- Data Sheet: 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.
- Article: 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.
