Downstream Processing

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.

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.