Manufacturing

Mumbai, the location for its new Indian subsidiary, will also be the site for the company's Uniquity Global Conference on October 6, 2016.

Improvements to aseptic manufacturing procedures are long overdue. But how feasible is it for manufacturers to modernize fill lines of legacy products?

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.

Industry experts discuss best practices for selecting a separation technology.

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

This study offers a strategy for stabilization of biotherapeutics for long-term frozen storage in PBS-based formulations.

Airlines, airports, freight forwarders, and other cold-chain partners are taking a crash course in pharma cGMPs.

A company’s fill/finish individual facilities can be negatively impacted by a region’s economic climate, as currently observed at some of the pharmaceutical manufacturing locations in Puerto Rico.

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.

CSafe completed the acquisition of Kallibox, a manufacturer of cold-chain packaging solutions.

GE and Sealed Air extend their long-term collaboration to develop single-use films purposefully constructed for bioprocessing applications.

The initiative targets countries with less developed and evolving healthcare systems such as Latin America, South East Asia, and Africa.

The company is opening two offices in the United States that will offer serialization, automation, and process control services.

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

Agilent Technologies announces plans to build a new oligo manufacturing facility in Colorado that will double current capacity.

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

Zika vaccine development is hindered by technical challenges and funding shortfalls.

Catalent Pharma Solutions teamed with Zumutor Biologics to develop antibodies with enhanced ADCC activity.

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

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

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

Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.

Multiple methods are required for detecting and removing protein impurities.

Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates, discusses the regulatory requirements for improving manufacturing lines.