Manufacturing, Cell Culture and Fermentation

CDMO Celonic acquired a biomanufacturing facility in Heidelberg, Germany from Glycotope.

Anna Kireieva/Shutterstock.comSpeed to market is essential in the biopharmaceutical industry today.

ABEC, an equipment and engineering company, will provide a custom-made, single-use bioreactor to custom manufacturing firm, Emergent, for its Maryland manufacturing facility.

The companies have entered into a strategic collaboration to establish a new cell therapy and regenerative medicine manufacturing platform, which includes a new manufacturing facility in Belgium.

Under an agreement, ProBioGen will develop a stable cell-line for and manufacture an anti-cancer antibody for Chiome using its proprietary cancer cell-killing technology.

Detecting viral contaminants in biologic-based medicines-and identifying their source-requires a holistic testing approach.

Traditional planar culture formats are being superceded by microcarriers for large-scale cell therapy manufacturing.

Consider automation early in the rollout of clinical translation and scale up of clinical-trial protocols.

FDA noted in a recent inspection that US Stem Cell Clinic was processing and administering stem cell treatments that were neither reviewed nor approved by the agency.

Pfizer will invest $100 million to expand its manufacturing facilities in Sanford, North Carolina.

Media manufacturers are focused on reducing risk, improving quality and consistency, and managing costs.

Perfusion processes can attractive for biologics drug manufacturing; however, obstacles remain.

Traditional planar culture formats are being superceded by microcarriers for large-scale cell therapy manufacturing.

Sartorius Stedim Biotech combined the company’s ambr 15 bioreactor system with the Nova BioProfile FLEX2 cell culture analyzer for laboratory experiments.

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.

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

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.

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.

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.

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.

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.

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.