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Monoclonal antibody manufacturing

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Viral Safety in Bioprocessing
Viral safety in bioprocessing relies on a framework of (1) preventing contamination, (2) detecting contamination, and (3) removing or inactivating viral contaminants.
Software Simplifies Compliance with 21 CFR Part 11 and EudraLex Good Manufacturing Practice Volume 4 Annex 11
How software can simplify 21 CFR Part 11 and EudraLex Volume 4 Annex 11 compliance and provide additional benefits such as access control, audit trails and easier search and retrieval.
Improved 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
Scalability and Performance of Mobius® iFlex Bioreactors
This page summarizes several performance attributes and scalability data for Mobius® iFlex Bioreactors, single-use, stirred tank systems designed to support traditional and intensified fed-batch and perfusion cell culture applications.
Synthetic Carbon Adsorbents for Host Cell Protein Removal in Monoclonal Antibody Purification
Demonstration of the excellent capability of Carboxen® synthetic carbon adsorbents to reduce host cell proteins (HCPs) and recover monoclonal antibodies (mAbs) using a post protein A pool step.
Accelerated mAb Development Program – From Transfection to GMP Drug Substance in 9 Months
The accelerated mAb development program delivers GMP drug substance nine months from transfection. We designed the mAbExpress™ program to be fast, cost effective, and appropriate for the early clinical phase of your program, with regulatory support throughout.
Value Drivers and Benefits of Closed Processing
Closed processing enables more streamlined, flexible, and cost-effective multi-product and multi-modal facilities, while ensuring the highest level of product quality and safety. Learn more about how contamination risk is mitigated and the additional value and benefits of closed processing.
Improving Bioprocess Monitoring and Control with Multivariate Data Analysis
Multivariate data analysis (MVDA) makes possible a proactive, real-time approach to monitoring, controlling, and predicting quality and productivity in biomanufacturing. The use of proven software with guided PCA and PLS model creation means you don’t need to be a data
Transforming the Biopharma Supply Chain and Analytics Capabilities with eData
An essential step in the progress towards Pharma 4.0 is the conversion of paper-based data to an electronic format, allowing it to be transferred, received, and available at the right time, in the right place, by those who need it.
Optimizing CHO Cells for Higher Productivity
Cellvento 4CHO-X Expansion Medium enhances cell biomass for bioreactor inoculation in cell expansion stages.