The US FDA has identified quality problems at a Smithfield, Rhode Island plant where Alexion makes the immunosuppressant Soliris (eculizumab) and other products.
Pfizer has struck a strategic partnership with GE Healthcare to construct and equip a biomanufacturing centre focused on producing biosimilars for China.
Kite Pharma has opened a T-cell manufacturing facility in California it says can overcome the logistical problems of autologous therapies and treat up to 5,000 patients per year.
Novartis will continue investing in its manufacturing network to support a biologics pipeline which includes five new biosimilars it expects to launch by 2020.
Ajinomoto Althea has been granted a US patent for a whole antibody crystallization method that is faster at producing stable, biologically-active crystals than current techniques.
BioLife Solutions has partnered with transportation firm MNX and says it expects increased demand for its biologistics services as more cell therapies enter the clinic.
Shire will retain Baxalta’s biologics expertise and continue assessing its manufacturing network following the completion of its $32bn acquisition, expected next month.
Brammer Biopharmaceuticals and Florida Biologix have merged to create a cell and gene therapy biologics CDMO in preparation for a “tidal wave” of gene therapy products.
LeukoDx will develop a cell characterization system for GE Healthcare in a deal designed to bolster the latter’s cell therapy manufacturing technology offering.
The global contract and manufacturing organization (CDMO) announced the construction at a ground breaking ceremony held at its Ravensburg Schuetzenstrasse site.
Celltrion’s supply chain and warehousing procedures ensure the safe storage of Remicade biosimilars as demand fluctuates across markets, the drugmaker says.
JHL has completed “mechanical construction” of an off-the-shelf mAb plant in Wuhan, China days after UK regulators gave the go ahead for a trial of its rituximab biosimilar, JHL1101.
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.
Cell therapy development and production will not be sustainable unless there is a vendor-led shift to automated processes, said experts in Brussels yesterday.
Biocision has revamped its cell thawing platform to accommodate larger vial sizes and started developing an automated system for cell therapies in cryopreservation bags.
More plants in China will close says a US-based analyst who predicts that some drugmakers' inability to comply with stricter quality rules will create an opportunity for those that can.
GE Healthcare has teamed up with the Canadian Government and the Toronto-based Centre for Commercialization of Regenerative Medicine develop cell therapy manufacturing technologies.
Having a proactive approach to delivery technologies will give pharma firms a competitive edge against biosimilars and biobetters, according to device maker Bespak.
Sanofi Pasteur says Mexican approval for Dengvaxia vindicates the ‘industrial risk’ it took when it invested €350m in a dengue fever vaccine plant in 2009.
Unilife CEO Alan Shortall yesterday confirmed the drug delivery company is still “receiving interest from several parties under the strategic review process” and set a deadline of December 31 to announce any potential takeover. The company received its...
As GE ships the world’s largest ready-made biomanufacturing plant to China, the team involved tells us modular facilities are in demand from southeast Asian governments – and could hold the key to future pandemic treatments.
Changes to biologics manufacturing will have to go beyond swapping steel vats for single-use to adapt to future industry needs, says Amgen’s drug development expert.
Piramal chief executive Vivek Sharma won last week’s CPhI award for the pharma industry’s CEO of the year. Outsourcing-Pharma.com spoke to Sharma about his plans for the CDMO the day after the jury’s unanimous decision.
A $350m investment will make Regeneron’s Limerick plant “the largest-scale bulk biologics production facility in Ireland,” the firm says, and add a further 200 jobs.
Catalent says it is contemplating expanding its Wisconsin single-use biologics facility as strong demand from SMEs and biotechs has almost filled current capacity.
M+W has been contracted to build a £55m ($84m) manufacturing site that will support cell and gene therapy developers by the UK Government project, Cell Therapy Catapult.
Pfizer’s planned divestiture of its infliximab biosimilar candidate could create a race among competitors to gain access to the product, but in the early going, no clear leader has emerged.
French biotech TxCell is outsourcing manufacture of its T-cell therapy Ovasave to MaSTherCell, and says it expects to regain GMP certification of its own site later this year.
Mass produced regenerative therapies are a step closer say UK researchers who have developed a polymer substrate they claim can be used to set up “stem cell factories.”
Sartorius finished the first half of 2015 with increased sales, higher operating profits and a surge in orders that prompted it to raise its full year forecast.
Agilent and A*STAR have partnered to create quicker, more accurate ways of testing the sugar content of therapeutic proteins and monoclonal antibodies (mAbs) that are tailored for commercial producers.
In a rare move for the UK’s MHRA (Medicines and Healthcare products Regulatory Agency), the regulator has helped to “future-proof” CMO Fujifilm Diosynth Biotechnologies’ mammalian cell culture manufacturing facility in Billingham, UK against potential...
EMA guidance on process validation for drugmakers is the latest update in cGMP regulations to manage a pharma world shifting from chemical to biological processing, says NNE Pharmaplan.