Manufacturing

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.

Industry experts discuss the challenges of using single-use systems in biopharma manufacturing.

The authors present a case study in which four single-use vessels were fitted to an existing bioreactor system.

The study demonstrates a systematic approach to stabilize PBS-formulated mAbs against freeze-thaw degradation.

Amgen discussed the drug-delivery approaches to two of its biologics in a recent second-quarter earnings call.

NIST’s monoclonal antibody reference material can be used as a standard for biopharmaceutical analytical quality control.

The Phase I trial will test Bavarian Nordic’s vaccine, which is manufactured using a vaccine vector based on smallpox.

The therapeutic candidate AZD8601is an investigational mRNA-based therapy that will be tested for its ability to regulate the protein that influences vascular tissue growth.