Sanofi and Lonza will construct a large-scale mammalian cell culture manufacturing site in Switzerland, with an initial investment of CHF 290m ($288m).
Ohr Pharmaceutical Inc. has halted activities at the laboratory in San Diego, California where research on its sustained release delivery technology was carried out.
The European Commission has approved Celltrion Healthcare’s rituximab biosimilar – Truxima (CT-P10) – for the same autoimmune disease and cancer indications as the reference product.
CellGenix GmbH has started expanding its cell and gene therapy reagents facility in Freiburg, Germany citing the progression of customer projects into clinical development and commercial launch.
The Research Institute for Chromatography (RIC) and Anacura have joined forces to create anaRIC biologics, an R&D and GMP analytical specialist CRO for biologics.
TiGenix is using Lonza as a US CMO and Takeda as an ex-US commercialization partner to launch and trial its off-the-shelf stem cell therapy for a complication of Crohn’s disease.
Contract research organisation (CRO) ICON has taken a hit to its book-to-bill ratio after Pfizer dropped its anti-cholesterol candidate bococizumab in November.
Biocon's second fill/finish line at Bangalore site to come online later this year
Biocon’s biomanufacturing facilities in India will need a “meaningful capacity expansion” to cope with long-term global biosimilar demand, the firm says.
CMOs will struggle to compete with large in-house capacity investments, according to Results Healthcare which predicts a decline in outsourced biomanufacturing.
Thermo Fisher Scientific says it is buying Finesse Solutions, its long-term supplier of measurement and control solutions for bioprocessing applications.
Rumours of an Irish expansion freeze have been greatly exaggerated according to Eli Lilly, which says it remains committed to its Kinsale biomanufacturing site.
Amsterdam-based Kiadis Biopharma has received Health Canada approval to initiate a global Phase III trial for an allogenic stem cell therapy for acute leukemia.
Symbiosis has opened an office in Boston, Massachusetts citing growing demand for vial filling services for highly potent APIs and large molecule injectable formulations.
BriaCell Therapeutics Corp. has submitted a chemistry, manufacturing and control (CMC) amendment to the US FDA before its planned stem-cell based vaccine trial for late stage breast cancer.
GE Healthcare has teamed up with the Austrian Centre of Industrial Biotechnology (acib) in an effort to remove trial and error from the cell line optimization process.
Sanofi intends to resubmit its licensing application for Kevzara within the next few weeks following subject to a US FDA re-inspection of a French fill/finish plant.
If reinstated, Donald Trump’s order restricting travel to the US would hurt the cell therapy sector according to the International Society for Cellular Therapy (ISCT).
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.
Arven will use GE Healthcare’s FlexFactory manufacturing platform to increase capacity at its mammalian-cell based bioproduction facility in Kirklareli, Turkey.
Thermo Fisher Scientific, Inc. saw revenue grow 8% in 2016, mostly due to acquisitions of new Chromotography and mass spectrometry tech and expanding its Bioproduction.
Rentschler Biotechnologie has added an antibody stabilising platform to its manufacturing services through a strategic alliance with formulation tech firm Leukocare.
Sandoz withdrew its pegfilgrastim biosimilar application before responding to concerns about the lack of cGMP accreditation at the candidate’s manufacturing site, the EMA says.
The Novo Nordisk Foundation has awarded a DKK118m ($17m) grant to fund development of a fermentation pilot plant for cell line scale up experiments at the Technical University of Denmark.
Pfizer has resubmitted its antibody-drug conjugate Mylotarg (gemtuzumab ozogamicin) for regulatory review almost seven years after withdrawing it from the market.
