Manufacturing

High price tags threaten to block patient access to potentially life-saving cures and treatments.

Fujifilm’s center adds local support in Suzhou, China for cell culture media optimization.

Sartorius is investing €100 million (US$113 million) between 2021 and 2025 to expand capacities for production, innovation, and storage at its French facilities in Aubagne, Cergy, and Lourdes.

Sartorius will invest approximately €270 million (US$305 million) to expand its biopharmaceutical manufacturing activities in South Korea’s biopharm hub.

Autologous tumor cells engineered for immune system stimulation can target unique metabolic, genomic, and phenotypic characteristics of cancer cells.

Isolators move into smaller-volume processes, including cell and gene therapy manufacturing.

Defining expectations, such as GMPs, is paramount for sourcing the right biopharmaceutical raw materials.

Confounding signals pose challenges to analytical methods necessary for managing residual impurity removal in biotherapeutic manufacturing.

Glycosylation monitoring has been heavily dependent on manual processes, but the automation of sample preparation streamlines the overall workflow.

Partnerships formed during the COVID-19 pandemic have provided a platform for change in assay development and transfers that should continue in the future.

Novozymes and Novo Nordisk Pharmatech are teaming up to develop best-in-class technical enzymes to support biopharmaceutical production processes.

BeiGene has acquired property in Hopewell, NJ to build a new manufacturing site and clinical R&D center for advanced new medicines.

Samsung Biologics, GreenLight Biosciences, and Environmental Impact Acquisition Corp. have partnered to advance GreenLight’s mRNA COVID-19 vaccine candidate.

The companies are testing their existing vaccines against the new variant of concern and are pursuing variant-specific versions.

The Comirnaty vaccine received a positive opinion from the EMA’s CHMP for children five to under 12 years of age.

Speed to market, flexibility, and digitalization are important topics in biopharmaceutical manufacturing.

Scientific innovation and regulatory reformations are helping to drive the global biopharma market forward, but a balance between cost and value still needs to be accepted for widespread adoption.

Jordi Serrat, Product & Technology Director, Azbil Telstar talks about the role of disruptive and digital technologies in aseptic processing.

Global supply chain experts examine implications of the DSCSA as well as topical considerations around the EU's FMD in this serialization video series ft. manufacturing, packaging, software, and regulatory experts.

Novavax has announced that EMA has started its review of a conditional marketing authorization application for its COVID-19 vaccine, NVX-CoV2373.

Lonza is expanding its microbial development capabilities at its Visp, Switzerland, site to support clinical and commercial drug development programs.

Rafael Beaus, Global Consultancy Manager, Azbil Telstar, discusses Annex 1 and trends in aseptic production.

Luke Stockhausen, Lead Process Engineer, CRB, talks about technological advances, processing line changes, and new solutions to overcome challenges in aseptic processing.

Global supply chain experts examine implications of the DSCSA as well as topical considerations around the EU's FMD in this serialization video series ft. manufacturing, packaging, software, and regulatory experts.

Synthace has raised $35 million in funding to fuel growth of its life sciences R&D technology.

Richard Denk, Senior Consultant Aseptic Processing and Containment, SKAN AG, discusses the evolution of aseptic processing with a particular focus on isolators.

Patrick Nieuwenhuizen, Senior Manager/Consultant, PharmaLex, discusses changes to regulatory requirements, quality risk management, audits, and operational considerations of aseptic processing.

Global supply chain experts examine implications of the DSCSA as well as topical considerations around the EU's FMD in this serialization video series ft. manufacturing, packaging, software, and regulatory experts.

Fujifilm is expanding its R&D footprint at its California facility.

Baxter will invest $100 million in new lyophilization equipment and an additional aseptic syringe filling line at its Halle/Westfalen (Germany) location.