다운스트림 바이오공정의 생산성 극대화

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.