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Celltrion's MabThera cleared by EC for autoimmune diseases and cancer

22-Feb-2017 - 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.

Abzena to make wet-AMD antibody drug candidate for UCL at US plant

21-Feb-2017 - Abzena Plc has been contracted to make an antibody drug candidate for wet age-related macular degeneration by developers at University College London.

CellGenix GmbH starts work on cell therapy regent facility expansion

21-Feb-2017 - 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.

Belgian CRO launches EU joint venture with Chromatography Institute

20-Feb-2017 - 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.

Selecta hires Lonza to make synthetic vector delivered gene therapy

17-Feb-2017 - Selecta Biosciences Inc. has hired Swiss contractor Lonza to make a gene therapy candidate for the metabolic disease, Methylmalonic Acidemia (MMA).

TiGenix hires Lonza to make cell therapy for Crohn's disease complications

17-Feb-2017 - 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.

Biocon's second fill/finish line at Bangalore site to come online later this year

Mylan and Biocon Neulasta biosimilar to go under US FDA scrutiny

17-Feb-2017 - Biocon’s biomanufacturing facilities in India will need a “meaningful capacity expansion” to cope with long-term global biosimilar demand, the firm says.

Bio-outsourcing share to drop as Big Pharma invests heavily in-house, analyst

15-Feb-2017 - CMOs will struggle to compete with large in-house capacity investments, according to Results Healthcare which predicts a decline in outsourced biomanufacturing.

Lilly rejects reports US tax plan prompted Ireland investment rethink

14-Feb-2017 - Rumours of an Irish expansion freeze have been greatly exaggerated according to Eli Lilly, which says it remains committed to its Kinsale biomanufacturing site.

BriaCell files CMC amendment and preps for breast cancer vaccine trial

10-Feb-2017 - 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. 

Pfizer to shut Australian Neulasta biosimilar plant and move production to Croatia

10-Feb-2017 - Pfizer will close the Australian plant which produces the API for HSP-130, a candidate version of Amgen’s Neulasta, and shift production to Croatia.

Aurobindo building Indian manufacturing plant to support 12 biosimilar pipeline

10-Feb-2017 - Aurobindo’s first biomanufacturing facility will be commissioned this year, the firm said after adding four candidates to its biosimilar pipeline.

Sanofi awaits FDA inspection of fill/finish plant before Q1 Kevzara resubmission

09-Feb-2017 - 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.

Catalent running its biologics business at over 90% capacity

08-Feb-2017 - Catalent is struggling to keep up with demand for its biomanufacturing services, but a third production train will open up more capacity from October.

Roche: 'Largest biomanufacturing capacity across the industry' to get bigger

07-Feb-2017 - Roche says it will continue to expand its biologics manufacturing capacity while reducing its small molecule network.

GE Healthcare's 'Cell line agnostic' FlexFactory to boost Turkish biosimilars business

07-Feb-2017 - Arven will use GE Healthcare’s FlexFactory manufacturing platform to increase capacity at its mammalian-cell based bioproduction facility in Kirklareli, Turkey.

Trump's travel restrictions will hurt cell therapy sector says ISCT

06-Feb-2017 - 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).

AUTOLOGUS CELL THERAPY

Opexa 'eliminates major liabilities' by selling Texas facility to KBI

06-Feb-2017 - CDMO KBI Biopharma, Inc. has acquired the lease and assets of Opexa Therapeutics’ facility in Texas after the firm’s lead MS candidate failed Ph IIb.

Arven installs GE "Cell line agnostic" FlexFactory to grow Turkish biosimilar business

03-Feb-2017 - Arven will use GE Healthcare’s FlexFactory manufacturing platform to increase capacity at its mammalian-cell based bioproduction facility in Kirklareli, Turkey.

Amgen pledges Trump 1,600 US jobs, but how many are in bioproduction?

03-Feb-2017 - 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.

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