Upstream Processing

This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products.

An increase in biologics raises awareness of particle generation and its role in negative patient outcomes.

BioVectra will open its new microbial fermentation and complex chemistry site, including the capability to handle high-potency APIs, by the end of 2017.

MilliporeSigma released a new surface-active nonionic polymer to ensure lot-to-lot consistency.

Can bioprocessing runs be consistently replicated in an inherently variable production environment?

Improving the bioreactor growth environment increases the rigor of bioprocessing runs.

GE Healthcare continues to ramp up its offerings in the bioprocessing space with the purchase of Asymptote and a continued partnership with Zenith Technologies.

OrlaSURF technology can be used for the development of target-binding assays to monitor the binding of an ADC to its antigen.

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

Sanofi and Lonza formed a joint venture to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland.

CellGenix will add R&D, production, and warehouse space in Freiburg, Germany for GMP-grade raw materials for cell therapy, gene-therapy, and tissue-engineered products.

Under the agreement, Abzena will manufacture magacizumab, an antibody created using the ‘Abzena inside’ Composite Human Antibody technology.

This three-year partnership will explore and identify new tools and methods to modify and optimize the Chinese hamster ovary (CHO) cell line performance.

A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.

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

Language surrounding regenerative medicine and the REGROW Act appeared back into the 21st Century Cures Act right before it passed. What will this mean for the controversial testing and marketing of stem-cell therapies?

UK-based Orchard Therapeutics and PharmaCell ally to support clinical trials and commercialization of Orchard’s ex-vivo gene therapies.

The authors describe the development and validation of a highly sensitive point-of-use pressure decay test.

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

The baculovirus-insect cell system can produce large quantities of complex protein in a short period of time.

EMD Millipore’s Mobius Power MIX 2000 can mix buffers, culture media powders, and other challenging materials.

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.

To investigate the best culture conditions, the authors used response surface methodology via Box-Behnken design.

Oxford Genetics has secured a GBP1 million capital from investment group Mercia Technologies to support its growth strategy in delivering new services for cancer-fighting gene-therapy technologies.

BioPharm International spoke with Trevor Marshall, director of enterprise systems integration at Zenith Technologies about automating processes in upstream processing.

Horizon announces new bioproduction outlicense deal with an unnamed partner for a minimum value of £500,000.

Scientists from the Fred Hutchinson Cancer Research Center have developed a semi-automated benchtop system for the manufacture of gene therapy.

BioPharm International spoke with Selexis CEO and Chairman Igor Fisch, PhD about the latest cell-line development advances.

Experts discuss recent advances in cell viability testing methods in bioreactors.

WuXi AppTec’s new biomanufacturing facility is its third facility in the Philadelphia, PA Navy Yard.