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.
Biopharma is ramping up the outsourcing of some of the easier tests while tasks such as downstream process development and QbD services are being outsourced less, according to a new survey.
Bristol-Myers Squibb and Samsung Biologics have expanded their existing agreement in which Samsung will manufacture several unnamed biologics at its Incheon, South Korea manufacturing site. Financial terms of the agreement were not disclosed.
Thermo Fisher has launched a pump technology designed for applications across the bioprocessing production line and usable with "all" bioprocessing tech.
The thin profit margins associated with relatively simple sterile products has led to a reluctance to invest in operations and shortages, according to an industry expert.
‘Podular’ manufacturing systems will dominate facility design within five years, say G-CON and GEA who have teamed with Pfizer to create a flexible, repurposable and portable facility.
After making significant investments in its personalized immunocellullar manufacturing technology, Prima BioMed is looking to scale up the platform as the company’s lead product enters Phase II trials.
German regulators have approved a 3D manufacturing process that Pluristem Therapeutics claims can produce cell therapies faster and more cheaply than standard methods.
Sanofi and French biopharma Transgene will soon begin construction on their new €10m ($13.5m) manufacturing plant, which will produce viral vectors for Transgene's targeted cancer immunotherapy, TG4010.
The US Defense Advanced Research Projects Agency (DARPA) has awarded MIT’s Biomanufacturing Research Program (BioMAN) a $10.4 million grant from to develop devices and techniques to more rapidly produce biologics.
The new UK biomanufacturing hub will help BioPharmas cut costs and let those developing novel biodrugs assess manufacturability according to the Centre for Process Innovation (CPI).
ATMI has started selling a new cGMP-compliant fill finish platform in a continuation of its focus on what it says is the growing single-use tech market.
Oxford Biomedica has bought RecipharmCobra Biologics’ manufacturing facility in Oxford, UK, to reduce its reliance on third-party production of its gene delivery technology.
Revenues fell 3 per cent in 2009 at SAFC but pharmaceutical sector demand for vaccine manufacturing products helped firm finish year with six months of growth.
Canadian biologics CMO BioVectra has been contracted to make trial supplies of the candidate cancer treatment Prolanta by US biopharmaceutical firm Oncolix.
Althea Technologies’ biologics and injectables contract development, manufacturing and testing facility in San Diego, US is open for business, bringing to an end the firm’s two year campaign to expand capacity.
Novozymes and Millipore have launched an animal-free culture supplement, which has been designed to reduce risk and regulatory pressures in upstream biopharmaceutical processes.
Technology and services provider Althea Technologies has stepped
closer to a significant increase in manufacturing capacity as it
announces the completion of the first phase of construction at its
new San Diego facility.
The production capacity for biopharmaceutical manufacturing will
expand an average of 48 per cent over the next five years for
mammalian and microbial production systems, according to an
industry survey.
