Downstream Processing

Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.

The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.

Although Protein A remains a top technology for monoclonal antibody purification, the industry continues to look for new approaches to improve conventional capture chromatography.

Pump systems must be designed to meet the needs of specific processes, including preventing cross-contamination and damage due to shear forces.

The membrane-based Protein A purification tool was unveiled at the 2017 PepTalk Conference in San Diego, California.

Excipient selection strongly influences lyophilization performance for biologic drugs.

There is much work to do to achieve efficient, cost-effective production processes.

A novel coiled flow inversion reactor (CFIR) improves process productivity and performance.

In addition to having the optimal cell line and process, it is crucial to have the optimal cell culture medium and feed to maximize performance potential.

Advances in technology are increasing the productivity and efficiency of commercial-scale chromatography bioprocesses.

A new virus-retentive membrane may be used to filter chemical-defined cell culture media for risk mitigation.

Improvements to aseptic manufacturing procedures are long overdue. But how feasible is it for manufacturers to modernize fill lines of legacy products?

Industry experts discuss best practices for selecting a separation technology.

Advances in cell culture media technology have helped achieve safer biologics.

Irvine Scientific’s new product range includes chemically-defined, serum-free media, to increase productivity of viral vectors and recombinant proteins in suspension cultures.

An MIT-developed system uses microbes for manufacturing small amounts of vaccines and other therapies.

Multiple methods are required for detecting and removing protein impurities.

CMOs are working hard to improve performance by investigating new technologies for filtration and purification.

The affinity purification company will set up shop at the former Merck & Co./GlycoFi facility in the Dartmouth Regional Technology Center in New Hampshire.

FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.

Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods.

CPhI Pharma Awards seek nominations for excellence in biopharma development and manufacturing.

MilliporeSigma and the International Vaccine Institute in Seoul, South Korea aim to develop more robust, scalable vaccine manufacturing processes.

Technology advances enable contract service providers to keep pace with the demands of existing and emerging biologic-based therapies.

Advances in cell line engineering, process optimization, and in-vitro glycosylation are making a difference.

MilliporeSigma expands its Carlsbad, California-based GMP capacity for viral and gene-therapy products by nearly 90%.

Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk mitigation.

The company announced the launch of its first-in-class Lynx CDR connectors at INTERPHEX 2016.

The authors review the technologies that may help bioprocessing become a truly continuous operation and present case studies that could contribute to the integration of upstream and downstream platforms.

The authors provide application data to support the use of SEC beyond small-scale operations.