mAbs Downstream
Products for Development and Manufacturing
Higher cell densities and antibody titers from increasingly advanced upstream processes result in complex downstream purification challenges. The downstream workflow, which includes clarification, chromatography, concentration, viral clearance, and sterile filtration steps, is essential for ensuring monoclonal antibody (mAb) product quality, yield, safety, and sterility.
Procesamiento Downstream
Maximize Productivity of Downstream Bioprocessing
The downstream process consists of many purification and filtration unit operations, each of which must be robust, scalable, and optimized to mitigate loss of the monoclonal antibody (mAb) and maximize product yield.
Combine these technologies with our application expertise to overcome any downstream processing challenge.
Categorías relacionadas
Sterile filtration is crucial for bacterial removal in drug production and bioprocessing.
Our range of affinity resins are designed for high throughput and cost-effective purification.
Our AEX and CEX resins offer efficient purification solutions for mAbs, and other modalities.
From pilot to process-scale, our chrom systems are designed to provide robust, consistent performance.
Our viral clearance portfolio includes the virus filtration solutions, chemicals, holders and systems.
Ultrafiltration & diafiltration increase capacity, concentration, and recovery in bioprocessing.
Recursos relacionados
- 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.
Vídeos relacionados
Explores nuestras soluciones
Para seguir leyendo, inicie sesión o cree una cuenta.
¿No tiene una cuenta?