Downstream Processing

Industry experts provide insights on the challenges and importance of using buffers in downstream processing.

Headspace moisture analysis is a rapid non-destructive analytical method that may potentially address the limitations of traditional methods used for residual moisture determination.

Experts in the field share some best practices for optimizing process economics in biomanufacturing.

The necessity to detach cells from a culture substrate during cell harvesting remains one of the most challenging steps in a cell-culture process.

Novasep is building a new synthesis laboratory and adding capacity for kilogram-scale batches of synthetic molecules that are needed for biological testing and preclinical trials, at its Pennsylvania, US facility.

The authors explore the use of precipitation using polyvinyl sulfonic acid and zinc chloride in place of capture chromatography to reduce the cost of goods in the insulin manufacturing process.

mstay/Getty ImagesBiopharmaceutical manufacturing involves a series of complex unit operations linked together to provide high-purity, biologic actives with specifi

BioPharm International sat down with Kevin Isett, PhD, co-founder and CEO of Avitide, to find out why he thinks the company’s tailored approach to purification resins will change the face of biopharmaceutical separation.

A new consortium involving Arecor, FUJIFILM Diosynth Biotechnologies and the Center for Process Innovation will focus on formulation innovation as a way to improve downstream processing and reduce biopharmaceutical cost.

The UK’s National Biologics Manufacturing Centre will use Novasep’s BioSC Lab for protein purification.

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.