Manufacturing

An approach to stabilize PBS-based formulations could provide a simple physiological solution for use of proteins in research, preclinical, diagnostics, and clinical studies, as well as commercial biotherapeutic products.

A new virus-retentive membrane may be used to filter chemical-defined cell culture media for risk mitigation.

Ravi Limaye gives an overview of the biosimilar industry and projects for 2020.

Onset expanded its product line for pharmaceutical cold-chain management with the launch two new products.

Wells Pharmacy Network is voluntarily recalling all of its products due to sterility concerns.

Researchers from the Wyss Institute explain a potential method for transporting and producing temperature-sensitive pharmaceuticals at a reduced cost.

R-Pharm Group, a private Russian pharmaceutical company, has opened a biopharmaceutical production plant in Yaroslavl, Russia, to produce biologics and biosimilars to treat autoimmune diseases and cancer. The facility, which has a line capacity is 2,000 L of cell culture per production cycle, is ready to be validated to US and Russia FDA and GMP requirements, the company reports.

Genentech’s biologics drug substance plant is the overall winner of the International Society for Pharmaceutical Engineering’s 2016 FOYA Awards.

Clinical biotechnology company Moderna Therapeutics will build an integrated clinical manufacturing facility for mRNA production in Norwood, Massachusetts.

GE Healthcare’s GE BioPark Cork will hold four KUBio manufacturing facilities; GE will also collaborate with NIBRT for biopharmaceutical training.

Industry concerns have generated efforts by FDA to streamline the system for designating the lead center to regulate a new combination product.

FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.

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.