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Headlines > Upstream Processing

'One-litre bioreactor scale currently the maximal for stem cell expansion and differentiation'

Industry needs new bioreactor and monitoring tech for stem cell scale-up, expert

24-Mar-2017 - Stem cell therapy developers are lacking production scale-up technologies, says the chair of an upcoming conference bringing industry and academia together to address the problem.

Caladrius: 'Hitachi will unlock full potential of cell therapy CDMO PCT'

24-Mar-2017 - Hitachi Chemical Co. America will increase its presence in the cell therapy development and manufacturing space through the $75m acquisition of Caladrius Biosciences subsidiary PCT.

GSK breaks ground on $175m German Bexsero vaccine facility

21-Mar-2017 - GlaxoSmithKline has broken ground on a €162m ($175m) meningococcal B vaccine production plant in Germany.

Trailer Park Bios? Germfree wheels out mobile cleanroom to fill production gaps

14-Mar-2017 - Florida, US-based aseptic control and biosafety services firm Germfree has launched the latest in its mobile cleanrooms, the Mobile Adaptive Bioproduction Suite.

Horizon inks optimisation tech deal for next generation CHO K1 cell line

10-Mar-2017 - Horizon Discovery Group has teamed up with Amplycell to optimise its GS (glutamine synthetase) null CHO K1 cell line.

BeiGene forms JV to build biologics plant in Guangzhou

08-Mar-2017 - BeiGene Ltd has said it will build a biologics manufacturing plant in collaboration with Guangzhou Development District (GDD).

Fetal attraction? FBS supplier offers price guarantee for 'cell food' mainstay

03-Mar-2017 - Lot-to-lot consistency is key for fetal bovine serum (FBS) supply, says Nucleus Biologics which is offering clients stable volumes and prices on its single-sourced serum.

Jazz: 24/7 production shifts could help stem Erwinaze shortage

01-Mar-2017 - Non-stop production shifts are among initiatives being tested by Jazz Pharmaceuticals to up supply of orphan drug Erwinaze after its CMO received an FDA warning letter.

Bio CDMO space: Fujifilm looking to challenge Lonza and B-I

28-Feb-2017 - Fujifilm has separated its biopharmaceutical contracting business in an effort to triple its revenues to ¥100bn ($890m) within seven years.

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.

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.

Thermo Fisher bags single-use bioreactor tech partner Finesse

14-Feb-2017 - Thermo Fisher Scientific says it is buying Finesse Solutions, its long-term supplier of measurement and control solutions for bioprocessing applications.

Novasep’s €27m viral vector plant to create up to 100 Belgian jobs

14-Feb-2017 - The new viral vector production facility will contain two GMP suites equipped with single-use bioreactors ranging from 200L to 2,000L, says Novasep.

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.

TapImmune improves T-cell vaccine formulation ahead of Ph II trials

03-Feb-2017 - TapImmune has completed a multi-gram scale-up and GMP manufacturing of its lead product as it prepares for various Phase II studies.

FINANCIAL REPORT

Thermo Fisher's cautiously optimistic outlook for 2017

02-Feb-2017 - 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.

Novo Nordisk Foundation grants $17m for pharma fermentation pilot plant

01-Feb-2017 - 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....

Single-use once again growth engine for Sartorius

31-Jan-2017 - Sartorius reported a 22% year-on-year growth in sales in its bioprocessing division, driven by continued demand for single-use systems.

Patented GE bioreactor bag boasts of 214m CHO cells/mL in perfusion mode

31-Jan-2017 - GE Healthcare says a new inflatable bioreactor bag configured in perfusion mode can achieve a cell density over four times that of the current industry standard.

Biocon wins $68m Malaysian contract for biosimilar insulin and pen supply

26-Jan-2017 - Biocon has been awarded a three-year contract to supply recombinant human insulin formulations made at its Malaysian facility to the country’s Ministry of Health.

FDA hits UK state-owned CDMO with warning over leukemia drug production

25-Jan-2017 - Porton Biopharma says it is undergoing a manufacturing review to address US FDA concerns about the production of Jazz Pharmaceuticals’s orphan drug Erwinaze.

ADMA to buy US Biotest plant and fix problems that derailed RI-002

24-Jan-2017 - ADMA Biologics has agreed to buy production assets from the CMO whose manufacturing deficiencies saw the US FDA reject its lead candidate, RI-002, last year.

Biopharma survey: Shortage of bioprocessing talent key threat to sector

20-Jan-2017 - Industry is struggling to find and develop skilled bioprocessing workers according to respondents to NIBRT’s biopharma trends survey.

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