Manufacturing

FDA has approved Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy from BioMarin Pharmaceutical for treating severe hemophilia A in adults.

To overcome the challenges of the widening range and scope of products that require aseptic processing and the evolving regulatory landscape in this field, companies should deepen their knowledge base on best practices.

Manufacturers face the challenge of meeting growing demand for personalized biopharmaceuticals.

Detection of nitrosamines in several commercial drugs has resulted in manufacturing batch recalls followed by a review of the APIs’ synthesis processes by MAHs.

Ross Engineering custom fabricates tanks, pressure vessels, and reactors for various manufacturing and storage functions.

Bruker Corporations timsTOF Ultra mass spectrometer features a captive spray ionization ino sources that provides optimized vortex gas flow.

TurboFil Packaging Machines Mini-Monoblock MDN-50 is designed to accurately and expediently fill, seal, cap, and label spray multi-dose nasal dispensers.

Beckman Coulter Life Sciences’ Light Array Module enables high-throughput screening and process optimization for various phototrophic organisms.

A novel complement therapeutic CTx001 offers a novel approach to treating geographic atrophy.

Tower Cold Chain will soon open its new headquarters in Philadelphia.

Webinar Date/Time: Thu, Jul 20, 2023 11:00 AM EDT

Geert Moens, Global Platform Leader Vial Closure Systems, Datwyler Healthcare, discusses recent technologies in the film and spray coatings market.

The prestigious award, worth €20,000 (US$22,000), goes to Maurice Michel of the Science for Life Laboratory at Karolinska Institutet, Stockholm, Sweden.

Aenova has opened a new building for the production of highly potent APIs in Germany.

The new headquarters located in Columbus, Ohio, more than triples Andelyn Biosciences’ footprint to meet growing demand for CGT services.

PIF has established Lifera, a new manufacturing entity that will manufacture, stockpile, and supply bio/pharmaceuticals both locally and through partnerships.

India’s Enzene Biosciences is investing $50 Million into a new biopharma manufacturing plant in Hopewell, NJ.

The new facility also provides a plan for scalable product production processes that can potentially be replicated by Vaxxas domestically and globally.

The integration of the binders into a routine lateral flow test will support the clinical and commercial development of rapid diagnostics for Alzheimer’s disease through nasal sampling.

Mendus and NorthX Biologics will work to develop and commercialize Mendus’ lead asset, vididencel, an allogeneic dendritic cell vaccine.

Charles River’s off-the-shelf lentiviral vector packaging plasmids are intended for use with cell and gene therapies.

The investment, which is taking place in Hillerød, Denmark, will aim to create more production capacity and increase the company’s ability to meet future market demands and to continue development on its future clinical late-phase product portfolio.

The new excipients manufacturing facility is expected to be completed in 2025.

The collaboration between Samsung Biologics and Pfizer will focus on long-term biosimilars manufacturing.

Webinar Date/Time: Tuesday, June 27th, 2023 at 8am EDT | 1pm BST | 2pm CEST | 5am PDT Wednesday, June 28th, 2023 at 8am EDT | 1pm BST | 2pm CEST | 5am PDT Thursday, June 29th, 2023 at 8am EDT | 1pm BST | 2pm CEST | 5am PDT