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...
WuXi PharmaTech subsidiary WuXi Biologics has begun construction on a new $150m biologics manufacturing facility in Wuxi, China, which is expected to be the largest mammalian cell culture manufacturing sire using disposable bioreactors in the world.
Cell-based cancer immunotherapy company Juno Therapeutics has entered into a lease agreement for a manufacturing facility in Bothell, Washington to produce its developing cell therapies.
Contract manufacturer Piramal recently approved a $20m capacity expansion for hormonal and antibody drug conjugate (ADC) manufacturing at its facilities in Morpeth, UK, and Grangemouth, Scotland.
Third-party manufacturers anxious about Big Biopharma investments and downbeat industry reports can relax as experts concur “it’s a time of growth for biopharmaceutical outsourcing.”
As the fight over naming biosimilars continues in the US, the WHO has drafted its own system of biological qualifiers to ensure biosimilars remain unique from their biologic counterparts.
CDMO (contract development and manufacturing organization) PacificGMP has doubled its GMP (good manufacturing practice) production capacity with the addition of a second System 1000 bioreactor platform from GE Healthcare.
SAFC, the custom manufacturing services business of Sigma-Aldrich, has installed a new commercial-scale continuous flow reactor at its Sheboygan, Wisconsin, facility with capacity to produce up to 150 kg of product per day.
Janssen has mirrored Pfizer’s concerns about the scale, price and robustness of using single-use technology for high-volume production but says industry collaboration could help bring standards in place.
The UK manufacturing sector covers all of its bases in terms of the current cell therapy manufacturing requirements and includes “a strong manufacturing base” to bring early phase academic research into the clinic, according to a survey conducted by Cell...
DISPATCHES FROM THE BIOLOGICAL PRODUCTION FORUM, DUBLIN
Single-use technology for high volume biomanufacturing is riddled with problems and will only be fully implemented by industry once the cost drops, according to Pfizer.
