Downstream Processing

This case study reviews how quality-by-design principles can be implemented in an intermediate chromatography purification step that uses cation-exchange chromatography.Abstract

Whether taking an upstream, downstream or holistic approach, there are many factors to consider when choosing viral clearance methods.

Two experts discuss best practices to achieve acceptable sterility assurance levels for aseptically filled products.

Industry experts discuss the development of process chromatography in bioprocessing.

Althea is expanding its existing biological drug product manufacturing operations to include highly active materials, such as antibody-drug conjugates, in a new facility near San Diego, CA.

Vetter plans to invest approximately 300 million Euros during the course of five years to expand drug product manufacturing and logistic services in Germany; upgrades will include an improved RABS system for aseptic processing.

Dynamic light scattering techniques can monitor viruses and virus-like particles in their native state.

Meissner’s FlexGro single-use biocontainer assemblies feature the TepoFlex polyethylene (PE) multi-layer film and are delivered presterilized for immediate use.

New single-use technologies and other filtration systems are beginning to address cost, throughput, and manufacturing footprint demands.

The company’s purification platform is thought to reduce the number of purification steps that are currently required for the manufacture of complex therapeutics.

Process maps and risk assessments are among the valuable tools operators can apply to reduce the risk of microbial contamination.

A thorough cell-bank testing plan is necessary to certify the safety and purity of a resulting biopharmaceutical product.

Optimization of each phase in a chromatographic cycle has a positive impact on productivity.

The new sizes follow the 2014 launch of the company’s fully disposable purifier.

The use of single-use systems in downstream processing offers benefits in filtration and sampling and may reduce the risk of contamination.

Advances in adventitious agent detection methodology are bringing benefits, but more work needs to be done.

Sartorius Stedim Biotech’s Sartoclear Dynamics is a clarification system designed to harvest mammalian cell cultures with high cell densities using single-use technology.

The new column features Natrix’s signature macroporous hydrogel.

BioSC Lab biochromatography system performs protein purification in batch and continuous modes.

Contract service providers share insights on biopharma market developments and the implications of biosimilar drug approvals.

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.