Contract packaging provider Reed-Lane adds dedicated room for vial and ampule kitting to its cold chain capabilities to limit intra-facility travel and product excursion as a means of security.
Bristol-Myers Squibb and PTC Therapeutics enter a long-term lease agreement giving the latter greater access to biologic production facility as it advances its treatments for rare genetic disorders.
Fujifilm completed the acquisition of Biogen manufacturing site in Denmark for $890m in a cash transaction as it works to expand its global business lines.
CGT Catapult reports that employment has increased substantially, and production capacity has grown by 60% in the UK cell and gene therapy manufacturing industry.
WuXi Biologics expands its biologics conjugation solution center to include space for commercial manufacturing of antibody-drug conjugates for the biopharma industry.
Harbour BioMed and an unnamed ‘leader’ in immunology enter license agreement to develop, discover, and commercialize biologic therapeutics using the former’s transgenic mouse platform.
SGS’ completed the ₤8.7m expansion of its large molecule testing facility in Glasgow and made room to increase its existing biosafety service and PCR platform capabilities.
Lonza will provide manufacturing for Alector’s Phase I drug candidates for neurodegenerative diseases from its Switzerland site, which is expected to be operational by mid-2020.
Vibalogics increases its single-use bioreactor and purification capacity with a new manufacturing line to meet demand for oncolytic virus and viral vector manufacturing services.
Samsung Biologics is providing contract development services for GI Innovation’s pipeline, with the first among five molecules to initiate development immediately, says company representative.
Bluebird bio opens its first wholly owned manufacturing facility to produce lentiviral vectors for the company’s investigational gene and cell therapies.
GE Healthcare partners for digital data exchange collaboration program with Amgen to advance understanding of biomanufacturing process on raw material variability.
Cambrex is investing $1m at its High Point, NC-based site, marking the most recent in a series of investments which will see the addition of 1,300 square feet and 15 new employees.
Securing the clinical supply chain comes down to the notion of ‘compliance’, which is transitioning from a ‘nice to have’ to a ‘need to have,’ says Cryoport.
Johnson & Johnson has unveiled a vaccine facility in Leiden, the Netherlands, which will focus on R&D, technological development, and large-scale production of vaccines for late-stage clinical trials.
Novartis is working with the US FDA to solve a manufacturing issue affecting Kymriah, identified as ‘variability in its commercial specifications’, says CEO.
Novasep has launched a downstream processing tool that combines batch and continuous chromatography for monoclonal antibodies, recombinant proteins and blood factors.
Ultragenyx Pharmaceutical is transferring fill/finish activities for Mepsevvi from Rentschler Biopharma’s facility in Germany, to Rentschler Fill Solutions in Austria.
Academic research underpins many of the early success stories in continuous manufacturing. Now, Blair Brettmann and her team are working to write another chapter by applying electrospinning and other techniques to downstream processing.
AstraZeneca says the build-up of biologics manufacturing capacity at its yet-to-launch facility in Sweden has contributed to a reduced core gross margin this quarter.
Novasep is investing €10m ($11.88) in a commercial fill/finish facility for viral vectors, mAbs, and other low-volume biologics, as part of its plan to double in size by 2022.
GE Healthcare Life Sciences has launched an updated, flexible cell processing system designed to rapidly and effectively harvest cells for treatments, including CAR T-cell therapy.