A novel coiled flow inversion reactor (CFIR) improves process productivity and performance.
Downstream Processing
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Fouling Mechanisms of Filters in the Harvest Development of Monoclonal Antibody Therapeutics—Pt 2
The authors evaluated the potential of direct filtration for multiple biopharmaceutical candidates. This article is Part 2 of the study.
Fouling Mechanisms of Filters in the Harvest Development of Monoclonal Antibody Therapeutics—Pt 1
The authors present a methodology to assess the contribution of individual filters to overall capacity of the direct filtration train, and elucidate how capacity is affected by characteristics of the cell culture broth and process parameters.
Stepping Up Process Control with Single-Use Systems
SUS aids biopharma manufacturers to overcome the rigidity of more traditional stainless-steel technologies.
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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.
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