Monoclonal antibody manufacturing

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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.

Optimizing CHO Cells for Higher Productivity

Cellvento 4CHO-X Expansion Medium enhances cell biomass for bioreactor inoculation in cell expansion stages.

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.

Extractables and Leachables Risk Assessment for Single-Use Systems

Before adoption of single-use technologies in biomanufacturing, manufacturers must assess the risk to the drug product from potential leachables. This article highlights a general approach based on the United States Pharmacopeia (USP).

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.

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.

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.

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.

Continued Process Verification for Quality

Continuous process verification maintains drug product quality and regulatory compliance throughout production.

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

Best Practices for Qualifying Single-Use Assemblies

Key aspects of single-use assembly qualification including quality by design (QbD), quality risk management (QRM) and operator handling and training.