Downstream Processing

This article reviews the definition of HCPs, risks posed by HCPs, regulatory concerns, commonly accepted ELISA methods for HCP measurement and their limitations, and orthogonal methods available for HCP characterization.

Removal of microorganisms is crucial when working with biologics. Sterile filtration offers a reliable, safe, and effective way to ensure product integrity.

Higher cell densities, greater demand for high-performance viral clearance, and desire for large-scale single-use technologies are driving development of filtration technologies.

The single-use clarification system eliminates centrigues; harvesting can be performed in one step; and process robustness and predictability are ensured.

Pall’s acquisition of BioSMB from Tarpon Biosystems expands its downstream continuous processing offerings.

Making the switch from batch to continuous manufacturing requires a thorough understanding of the process.

Large-scale implementation of Protein A chromatography offers several challenges.

Recent technological advances in the way biologic therapeutics are purified may bring size-exclusion chromatography back into the modern purification process.

The all-synthetic clarifying product line contains both an anion-exchange nonwoven media and a fine-particle, bioburden reduction membrane.

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.