Upstream Processing

The authors outline cell-line development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.

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

Model effectiveness is determined by the quality and composition of the data inputs.

The platform combines an expression system with equipment and process controls to enable rapid development and scale-up of robust titers.

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

Jacobs Engineering will provide engineering and construction services to expand the Novartis site in Huningue, France.

Jacobs Engineering Group was awarded a contract to provide engineering services and procurement for Alnylam Pharmaceuticals’ new manufacturing facility in Norton, Massachusetts.

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

Novo Nordisk broke ground on an expanded production plant for insulin in Kalundborg, Denmark.

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

In a lawsuit against Celltrion, Janssen alleges the GE subsidiary infringed one of Janssen’s patents covering the method of making the cell-culture media that HyClone later supplied to Celltrion.

Pfizer broke ground at its Andover, Massachusetts campus on a clinical manufacturing facility for complex biologics and vaccines.

Alvotech prepares for commercial biosimilar production in new facility with single-use bioreactors in Reykjavik, Iceland.

A new 20,000-L microbial biologics facility in Ireland will be operational by 2018 for Fujifilm Diosynth's contract development and manufacturing customers.

The collaboration will provide GMP manufacturing ahead of future clinical studies.

Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.

Early successes drive the need to overcome safety issues, increase efficacy, and address manufacturing challenges.

Developers of CAR-T cell therapies with products showing successful early-stage clinical results are currently seeking manufacturing capacity that will enable the production of the larger quantities of material needed for Phase III trials and eventual commercialization.

Two main safety issues have been identified in the early-phase clinical trials conducted to date for chimeric antigen receptor (CAR)-T cell therapies.

Cell therapy companies are attracting interest from investors, and drug companies are seeking partnerships and acquistions to accelerate development.

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

The National Institute of Health will conduct an internal review of the National Cancer Institute’s cell manufacturing facilities, which will affect multiple Kite projects.

Microchannels show potential benefits for inertial cell sorting and for introducing genetic material into cells.

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.

A modular cell-culture platform demonstrates accelerated process development.