Lonza Pharma & Biotech established itself in Israel, with the opening of a collaborative hub aiming to advance manufacturing technology for cell and gene therapy commercialization.
Sarepta Therapeutics signed a long-term, strategic manufacturing partnership with Paragon Bioservices to produce micro-dystrophin to grow its gene therapy program.
Lonza Pharma & Biotech will expand two of its manufacturing sites to reach the capabilities necessary to produce compounds bio-conjugates through to commercialization.
Fibrocell Science will make its gene therapy candidate FCX-007 from a facility in Pennsylvania previously dedicated to making its autologous personalised cosmetic Laviv (azficel-T).
French technology firm Cellnovo has selected Flex Ltd to build a production line in Romania, to manufacture insulin cartridges for its diabetes management system.
The US FDA has warned Lonza about operations at its facility in Walkersville, Maryland, raising concerns about validation and aseptic process simulations.
Florida, US-based aseptic control and biosafety services firm Germfree has launched the latest in its mobile cleanrooms, the Mobile Adaptive Bioproduction Suite.
The promised jobs were always part of Amgen’s 2017 plans says CEO Robert Bradway, but a reduced US footprint means hiring more biomanufacturing staff is unlikely.
Lonza and Boehringer-Ingelheim dominate the consolidated biologics CMO space but disposable technologies and improved yields are beginning to change this, says PharmSource’s Jim Miller.
Fixed-bed, high cell density bioreactors and a naturally occurring attenuated viral strain will be used by Batavia Biosciences in an attempt to produce an affordable rotavirus vaccine.
GE Healthcare is in discussions with companies looking to buy four fully-equipped ‘off-the-shelf’ facilities as part of a €150m investment into a biomanufacturing campus in Ireland.
Welsh chromatography resin maker Purolite says it aims to capture 30% of the Protein A market through its 100,000L facility on track to open next year.
Continuous manufacturing can reduce costs and is already being pursued by CMOs looking to increase productivity by up to 30%, says fluid processing tech firm LEWA.
Highlighting indications approved through extrapolation and manufacturing information in drug labels are attempts to raise doubts over the safety of biosimilars, according to Sandoz.
North Carolina State University’s Biomanufacturing Training and Education Center (BTEC) will use software developed by LZ Lifesceince to manage manufacturing operations under a deal announced today.
Distance and time differences are not barriers when choosing a biologics CMO, says Goodwin Biotechnology which has won a bispecific antibody process and scale-up contract from Russia’s IBC Generium.
Regulations, recruitment and facility refits are holding continuous manufacturing back, but a Rutgers’ associate behind J&J’s recent success believes industry can overcome these hurdles.
BioMarin expects commercial production of its recently approved orphan drug Vimizim (elosulfase alfa) to begin at a secondary facility in Ireland – acquired from Pfizer – mid-2017.
Potentially hazardous bio-waste generated at the UK National Biologics Manufacturing Centre (NBMC) in Darlington is being made safe using a bespoke system developed by Suncombe.
The UK biopharma industry is reporting difficulties finding manufacturing workers with the skills to make vaccines, biologics, and advanced therapy medicinal products (ATMP), according to ABPI.
CMO consolidation strategy has shifted from building scale and adding geographies towards niche technologies and biologics, according to the founder of trade association PBOA.
Cobra Biologics, a Swedish contract development and manufacturing organisation, has launched a project to improve scale-up of biologics with the University of Manchester, UK.
A new final rule from the US FDA now requires all drug and biologic manufacturers to notify the agency electronically of a permanent discontinuance or an interruption in manufacturing six months in advance, or as soon as is practical, before the disruption...
Small biotechs are turning to single-use to retain ownership of their manufacturing processes, says Merck Millipore as industry predicts continued double-digit growth for such systems.
The adoption of new technologies related to single-use bioreactors, disposable plastic containers, continuous purification processing, and real-time quality analysis are driving the next generation of biomanufacturing, according to a new report from the...
