Theravectys has outlined a 1-year plan to fix GMP deficiencies at its Paris facility and said the current manufacturing ban will not delay its clinical programmes.
ANSM has banned Theravectys from manufacturing candidate vaccines and immunotherapies at its Paris facility until September after observing critical GMP deficiencies during an inspection last year.
The larger the discount the more likely a US physician is to prescribe a biosimilar rather than an originator biologic according to the results of a survey.
MaSTherCell has completed test runs of T-cell therapy Ovasave says TxCell which has reiterated its intention to restart a trial of the drug in Crohn's disease this year.
A tarantula venom toxin that inhibits a novel pain receptor will guide development of more effective non-opioid painkillers say researchers in Australia.
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.
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.
Heat Biologics will no longer enrol patients in the arm of a Phase II trial examining its cell therapy HS-410 (vesigenurtacel-L) as a monotherapy for bladder cancer.
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.”
Japanese researchers have developed a peptide vaccine with the potential to protect the brain when administered prior to a stroke, according to a study presented at the American Stroke Association’s International Stroke Conference.
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.
Regenerative medicine developers now have a new supplier for mesenchymal stem cells (MSCs), the multipotent stromal cells derived from marrow and other tissues like muscle and dental pulp for tissue repair.
Reneuron has been granted a US patent for a cryopreservation technology that does not rely on toxic reagents and says it would consider licensing it to other stem cell therapy developers on a case-by-case basis.
Biocision has revamped its cell thawing platform to accommodate larger vial sizes and started developing an automated system for cell therapies in cryopreservation bags.
The US NIAID is supporting development of several experimental Zika vaccines but none will be ready before Brazil, the country at the centre of the current outbreak, hosts the Olympic Games this summer.
Nasdaq-bound Chinese biopharma BeiGene has chosen GE Healthcare’s Flexfactory platform for the monoclonal antibody (mAb) plant it is building in Suzhou.
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.
Making the newly approved asthma drug Nucala (mepolizumab) involves facilities on both sides of the Atlantic according to GSK, which says it has no plan to outsource production.
An Israeli researcher says a cost-effective method for making human liver cells offers drug developers better safety evaluation and will “undoubtedly” replace animal testing.
Scientists trying to curb malaria deaths usually concentrate on preventing mosquito bites or developing human vaccines and therapies, but novel gene-editing tool CRISPR is opening up another path.
Dyadic has agreed to sell its enzyme-producing fungal expression system and the rest of its industrial technology business to DuPont for $75 million (€70 million).
Epirus is set to file its Remicade biosimilar in 2017 and says the $3bn market will remain a large opportunity despite growing entrants in infliximab development.
Takeda has taken a stake in Belgian bioprocessing start-up Univercells as part of a programme aimed at supplying low-cost vaccines to lower-income countries.
Pfizer has announced an extra 90 production jobs at Dublin’s Grange Castle biomanufacturing site, adding to the 40 hires it plans for its API facilities in Cork, Ireland.
Catalent says it is contemplating expanding its Wisconsin single-use biologics facility as strong demand from SMEs and biotechs has almost filled current capacity.