The all-synthetic clarifying product line contains both an anion-exchange nonwoven media and a fine-particle, bioburden reduction membrane.
Downstream Processing
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Fouling Mechanisms of Filters in the Harvest Development of Monoclonal Antibody Therapeutics—Pt 2
The authors evaluated the potential of direct filtration for multiple biopharmaceutical candidates. This article is Part 2 of the study.
Fouling Mechanisms of Filters in the Harvest Development of Monoclonal Antibody Therapeutics—Pt 1
The authors present a methodology to assess the contribution of individual filters to overall capacity of the direct filtration train, and elucidate how capacity is affected by characteristics of the cell culture broth and process parameters.
Stepping Up Process Control with Single-Use Systems
SUS aids biopharma manufacturers to overcome the rigidity of more traditional stainless-steel technologies.
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They may not be glamorous, but buffers play an important role in biopharma manufacturing.
Tosoh Bioscience’s CaPure-HA hydroxyapatite chromatography resin is designed for the purification of monoclonal antibodies, polyclonal antibodies, and antibody fragments, and the separation of antibody isoforms and isozymes.
An increased need for higher-capacity resins and the demand for smaller batches has made disposable chromatography a more viable option.
Challenges remain for virus removal and validation.
Pall ForteBio introduces a solution for quantifying residual host cell proteins in CHO cells.
A quality-by-design approach that defines potential viral contaminants of source materials can be used to achieve viral clearance.
Careful selection of downstream processing conditions is a must.
Industry suppliers describe new technologies to facilitate downstream processing.
Suppliers see challenges to the adoption of single-use technologies for downstream processing as opportunities.
Grace's ProVance disposable Protein A chromatography column is designed for downstream purification.
OPUS technology designed to process large single-use bioreactor harvests.
The biopharmaceutical industry is developing a new approach to controlling variability in raw materials.
Research uncovers trends and factors affecting the pre-packed disposable chromatography columns market for downstream bioprocessing.
Experts discuss the advances in single-use technology for downstream bioprocessing applications.
Experts discuss the advances in single-use technology for downstream bioprocessing applications.
UPLC System for Nano- to Microscale Separations
Researchers are using current understanding of the lyophilization process to predict performance on many levels during both process development and manufacturing.
ALpHA G Capsule Filter for Single-Use Systems
Stain-Free Chromatography Workflow
A novel approach to sterile drug product manufacturing that uses a single-use assembly in a multi-product final filling suite with isolator technology offers benefits of efficiency and flexibility.
Advances in instrumentation, software, and methodologies provide more information than ever on the higher-order structure of proteins.
Automated sample handling, advanced glycan analysis and specially designed columns are helping biosimilar manufacturers speed up confirmation of the biosimilarity of their products.
Single-use systems and other technologies drive process efficiencies, but there is room for improvement.
With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process.
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