하류 생물공정 처리의 생산성 극대화
하류 공정에는 다수의 정제 및 여과 단위 작업이 포함되며, 각 작업은 단일클론 항체(mAb) 손실을 최소화하고 제품 수율을 극대화하기 위해 견고하고 확장 가능하며 최적화되어야 합니다.
공정 개발부터 규모 확대 및 본격 생산에 이르기까지, 밀리포르® 및 Sigma-Aldrich® 포트폴리오의 다양한 도구(완충액, CIP(현장 세척) 솔루션, 다회용 및 일회용 시스템, 플러그 앤 플레이 기술, 검증 서비스)를 활용하여 일정을 단축하고 비용 효율성을 보장하십시오. 이러한 기술을 머크의 응용 전문성과 결합하여 모든 다운스트림 처리 과제를 극복하십시오.
과립화 원료 사용, 다양한 공정 집약화 전략 구현, 폐쇄형 공정 채택 또는 디지털화 통합을 통해 다운스트림 생산성을 더욱 향상시킬 수 있습니다.
관련 카테고리
관련 자료
- Bioburden Control in Bioprocessing
Bioburden control in bioprocessing requires assessing the risks, mitigating the risks, and monitoring bioburden levels.
- Brochure: Mission: Control - Strategies for Effective Bioburden and Aseptic Control
In this series of articles, we provide information to highlight the differing objectives for bioburden control by unit operation and discuss the parameters that guide filter selection and optimization.
- Biochromatography Portfolio Guide
A guide to select your chromatography resins.
- What is Multi-Column Chromatography?
In this article, we will discuss one of the methods used to intensify the capture chromatography process: multi column chromatography (MCC).
- Viral Safety in Bioprocessing
This article summarizes important considerations for viral safety in mAb processing and outlines testing strategies for assuring the process will meet the viral safety targets. Download our Viral Safety eHandbook for more information.
- Tangential Flow Filtration in Downstream Bioprocessing
This article explains the different types of TFF, including single-use and multi-use, single pass TFF versus batch TFF.
- Single-Pass Tangential Flow Filtration Implementation and Scaling
This article discusses how to Implement SPTFF using Pellicon® Capsules and how to scale.
- Value Drivers and Benefits of Closed Processing
This article explains what is closed processing and expected benefits.
- Improve Process Understanding and Product Quality through Continued Process Verification
Continued process verification is critical to maintain the strength, quality, and purity of the final drug product. It is a regulatory expectation as manufacturers are instructed to ensure their process remains in a continual state of control. Learn more in this technical article.
- Use of stabilizers and Surfactants to Prevent Protein Aggregation
To prevent surface or mechanically induced aggregation because of pumping or shaking, surfactants or cyclodextrin can be used.
- pDADMAC Flocculation in Monoclonal Antibody Production Processes – Overcoming Regulatory Challenges with Quality Risk Management
The use of a flocculation agent such as a polycationic polymer polydiallyldimethylammonium chloride (pDADMAC), can improve clarification performance of high density feedstreams.
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