Manufacturing, Biologics

Applying lessons of raw materials’ characterization and supply-chain control from the semiconductor industry allow more rigorous control of the biopharmaceutical manufacturing process.

The authors of this study demonstrate an innovative method that is useful and complements traditional HA assays.

Limitations in traditional flu vaccine manufacturing methods underline the need for shifting to modern technologies.

Manufacturing differences between traditional mAb therapies and newer biotherapeutics dictate whether processes should be scaled up, scaled out, or use an alternate approach for commercial production.

The use of scale-down models allows for the theoretical optimization of processes and for troubleshooting problems during the developmental stage.

Accelerated timelines and small batch volumes of cell and gene therapies pose unique challenges for product-release testing.

GE Healthcare Life Sciences’ KUBio box is an integrated, flexible biomanufacturing environment for viral vector-based gene therapies.

The partners have developed a scalable, cost-effective purification process for adeno-associated viruses.

Ireland's National Institute of Bioprocessing Research and Training (NIBRT), together with technology providers such as GE Healthcare, and universities in Ireland and around the world, are developing courses that aim to close the gap between theoretical studies and practical workplace needs.

The new location is one of the world’s first digital facilities to use intensified, continuous biologics production technology.

Lonza, through its Ibex Solutions, will now cover preclinical and clinical development and manufacturing for a significant portion of Genmab’s pipeline.

Used with perfusion, alternating tangential flow and tangential flow filtration are redefining upstream efficiency.

Cloudleaf's Digital Visibility Platform can track which track location and additional environmental information, such as temperature, vibration, and shock, of sensors placed on raw material containers.

GSK’s expanded R&D and manufacturing facility in Upper Merion, PA houses a new analytical lab and flexible manufacturing equipment, including single-use bioreactors.

The new program, Cornerstone, integrates process development expertise and novel technology to remove development bottlenecks in the manufacture of gene therapy medicinal products.

FDA approved the drug after a successful open-label study of children aged six to 11 years and living with the condition.

The company’s Custom Single Run product line now has available bioreactors with working volumes of up to 6000 L.

Bayer will use ProBioGen’s GlymaxX technology to maximize the potency of its antibody drug candidate in development for oncological indications.

The new antibody, Citryll’s CIT-013, could offer new treatment options for various human diseases including lupus, vasculitis, pulmonary fibrosis, and organ damage due to sepsis.

The new facility, located in Ness Ziona, Israel, will support clinical phage manufacturing and can be expanded in the future to support commercial-scale manufacturing.

The joint venture, named BacThera, will operate out of headquarters in Basel, Switzerland and will serve pre-clinical to Phase II projects, with the ability to expand to Phase III and commercial manufacturing in the future.

In an effort to secure a continuous, sustainable supply of an important vaccine ingredient, Agenus is turning to a plant cell-based cell culture method for production.

Innovation in manufacturing technologies must occur to ensure the availability of gene and cell therapies.

The evolution of cell-culture technology is driving the need for improvements in modeling solutions.

A collaboration between Insilico Biotechnology and IFAT aims to develop a manufacturing, planning, and control system for the production of monoclonal antibodies.

The partners will collaborate to identify the bioactive components in hydrolysates, which have long been used as additives in cell culture media and feed formulation in the biopharma industry.

Pfizer is investing $500 million for the construction of a state-of-the-art gene therapy manufacturing facility in Sanford, NC.

BioPharm International spoke with Cindy Reiss-Clark, vice president, general manager, Biologics at West Pharmaceutical Services Inc., about the growing biologics market, specifically gene therapies, and how West is helping their clients prepare for these new trends.

The companies have entered into a manufacturing agreement for the production of Phase III clinical trial material.

The acquisition strengthens BioLife’s position as a supplier of disruptive, enabling solutions used for manufacturing, storage, and distribution of cell and gene therapies.