The non-proprietary naming debate is “almost a little comical” says Sandoz, which argues a proposed four-letter suffix adds little to aid post-marketing surveillance of biological products.
Differentiated technologies buoyed by the recent $600m conjugation deal with Roche is driving Catalent’s biologics business, the firm told Biopharma-Reporter at BIO.
Expect industry guidance on product communication soon says US FDA Commissioner Robert Califf, though a more pragmatic approach to social media will be taken.
Single-use technology is driving a new era in vaccine development says PnuVax which has acquired IP from GE Healthcare to produce an inactivated yellow fever vaccine.
The new 50,000 square foot facility in Lexington, MA will be dedicated to late phase development and commercial manufacturing for advanced cell and gene therapies.
A new $60m facility at a MSD site in Ireland will offer Fujifilm Diosynth customers 20,000L of microbial biologics capacity in a collaboration between the two firms.
Fully understanding a molecule’s mode-of-action (MOA) will be essential as industry begins developing the third generation of biosimilar products, according to Formycon.
Scaling-up without expanding its manufacturing footprint was key in selecting Pall's Xpansion bioreactor, says UCL which is looking to create “the world’s largest therapeutic cell bank.”
Cell Therapy Manufacturing & Gene Therapy Congress - Brussels, Belgium
The shelf life of a cell therapy product is crucial in determining a firm’s manufacturing strategy according to the makers of the first approved stem-cell based drug.
Reliance on third-party technologies is leaving T-Cell drug developers vulnerable and has driven the larger players to invest in their own platforms, say experts.
Dispatches from the Cell Therapy Manufacturing & Gene Therapy Congress
Cell therapy development and production will not be sustainable unless there is a vendor-led shift to automated processes, said experts in Brussels yesterday.
Contradictory requests from the US FDA on the statistical analysis of Remsima are one of many regulatory hurdles facing biosimilar developers, according to Celltrion.
The plant of the future will be increasingly equipped with disposable technology but single-use will never fully replace stainless steel, according to biomanufacturers at a recent industry event.
Pfizer reduced costs 40% without cutting jobs at a facility in Sweden using an alternative approach to organisational and cultural behaviour, and hopes to do the same at its newly acquired Austrian plant.
To benefit from breakthrough therapy designation (BTD) pharma companies must be willing “bet on the right data” according to Roche, which says this could be a challenge for smaller firms.
Sartorius has launched a cell harvesting technology, the first to incorporate diatomaceous earth filtration more commonly associated with the brewing industry.
Looking for a full-on partnership with Pfizer or a no-strings-attached manufacturing deal? Either way prepare for a tough screening process and don't be located too far from an airport.
Small biotechs should consider buying mothballed plants when scaling-up according to Protein Sciences, which says an ex-Pfizer facility was key to accelerating production of its vaccine Flublok.
J&J says it collaborated with Novartis and GSK to install wind turbines in Cork, Ireland to substantially reduce electricity costs at its local manufacturing plants.
Alexion has recalled another nine lots of Soliris after finding "visible particles" in vials of the $600,000-a-year drug for the third time in 10 months.
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.
A government funded bioprocessing institute is helping to drive biopharma investment and retrain workers in Ireland, and Biopharma-Reporter.com visited to find out what happens in this "flight simulator for biopharma manufacturing."
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.
Though industry has fully embraced single-use, manufacturers of such systems need to remove the risk of extractables and leachables and control the supply process according to Sartorius.
In light of the implementation of the Drug Quality and Security Act of 2013 in the US, which calls for the phased implementation of electronic tracking down to the package level, companies are looking at options to catch up and reduce counterfeiting at...
Aenova says the acquisition of Haupt Pharma and Patheon’s merger with DSM are evidence of consolidation in the CMO industry, as it looks to further increase its global footprint.
Catalent has increased its stake in Redwood Biosciences telling us it is committed to the development of antibody-drug conjugates (ADCs) and the SMARTag technology platform.
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.
Patheon and DSM’s Pharma Products merger is “highly complementary” with crossover limited to North American oral solid manufacturing growth, says DPx as it targets further growth opportunities.
‘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.
When Frank Sinatra sang "If you can make it there, you can make it anywhere" in New York, New York he probably wasn't talking about biopharmaceutical production.
