Cell lines

CAR-T before the bourse: Kymriah OK will ease fundraising but price an issue says ISCT

01-Sep-2017 By Gareth Macdonald

US approval for Novartis’s CAR-T cancer treatment Kymriah will help cell and gene therapy firms attract the investors they need to fund development according to International Society for Cellular Therapy (ISCT).

Oxford BioMedica could pocket $100m on Novartis CAR-T cell success

31-Aug-2017 By Dan Stanton

Oxford BioMedica saw its share price jump 21% after the US FDA approved Kymriah, the gene modified cell therapy made with the firm’s lentiviral vectors.

‘A new frontier:’ US FDA approves Novartis’ $475,000 CAR-T cell cancer therapy

31-Aug-2017 By Dan Stanton

Kymriah (tisagenlecleucel), made at the former-Dendreon site in New Jersey, has become the first gene modified cell therapy to be approved in the US.

CSL adding scalable stem cell gene therapy tech in $91m Calimmune buy

30-Aug-2017 By Dan Stanton

CSL Behring will launch itself into the stem cell gene therapy through the acquisition of Calimmune, adding a preclinical candidate and two manufacturing efficiency technologies.

CEO predicts fungal-based protein expression will be a 'CHO Stopper'

CHO platforms unsustainable for biopharma's future, says Dyadic

25-Aug-2017 By Dan Stanton

Industry is feeling the low yield and high cost limitations of the CHO cell line and must look to alternatives to make next-generation biological products, says fungal-based protein expression firm Dyadic International.

ACF bioanalytical plant opens as cell and gene therapies reach ‘tipping point’

24-Aug-2017 By Flora Southey

ACF Bioservices has completed the construction of its Exton, Pennsylvania, US-based facility for cell and gene product testing.

Oxford Genetics secures investment; expands UK facility and eyes US market

23-Aug-2017 By Dan Stanton

Oxford Genetics will expand its bioproduction services in the UK and target the US market through an office in Boston after receiving a £7.5m ($9.6m) investment.

AstraZeneca ups its mRNA stake through €25m Ethris deal

22-Aug-2017 By Dan Stanton

AstraZeneca has entered a five-year collaboration to develop therapies for respiratory diseases based on Ethris’ messenger RNA (mRNA) technology.

US FDA clarifies what constitutes 'minor' change to biologic production process

09-Aug-2017 By Gareth Macdonald

The US FDA has sought to clarify when biologics firms should inform it about minor changes to manufacturing processes in draft guidance this week.

Kite assesses EU manufacturing options as it submits CAR-T therapy for review

04-Aug-2017 By Dan Stanton

Kite Pharma has submitted the first CAR-T candidate axicabtagene ciloleucel to the EMA for review and says it is evaluating manufacturing options in Europe.

Horizon cell line sequence released in bid to up bioproduction efficiency

02-Aug-2017 By Dan Stanton

Horizon Discovery will allow researchers to modify a genome sequence based on its knock-out CHO K1 cell line in a bid to drive innovation in bioproduction.

Lonza sets CHF7.5bn 2022 sales target citing pharma drivers

26-Jul-2017 By Gareth Macdonald

Lonza Group AG has predicted it will generate annual revenue of CHF7.5bn ($7.9bn) by 2022, citing recent acquisition Capsugel and its new Visp-based Ibex manufacturing service as drivers.

Sanofi signs nanobody drug and tech deal that could earn Ablynx billions

21-Jul-2017 By Gareth Macdonald

Sanofi has licensed access to Ablynx NV’s nanobody platform as well as candidate drugs in a deal that could earn the Belgian firm billions of euros.

Recreated pox virus may yield vaccines and expression systems say scientists

18-Jul-2017 By Flora Southey

Researchers at the University of Alberta, Canada say a synthetic version of the extinct horsepox virus could yield more efficient protein expression systems and better vaccines. 

Spheryx awarded Ph II grant to modify tech for biologics industry

07-Jul-2017 By Melissa Fassbender

Spheryx, Inc. has been awarded a $1.5m grant over two years to support modifications to the company’s propriety protein aggregation detection and monitoring technology.

Takeda prepping to take over EU production of stem cell therapy from 2021

23-Jun-2017 By Dan Stanton

Takeda says it is assessing manufacturing options ahead of potential European approval later this year of the Crohn’s disease stem cell therapy licensed from TiGenix.

ImmunoCellular Therapeutics halts brain cancer cell therapy trial due to lack of cash

22-Jun-2017 By Gareth Macdonald

ImmunoCellular Therapeutics Ltd has halted a Phase III trial of its brain cancer cell therapy ICT-107 due to a lack of funds and is looking for a buyer or partner for the programme.

TxCell hires Lentigen to make vectors used to produce its organ rejection cell therapy

20-Jun-2017 By Gareth Macdonald

TxCell SA has hired Lentigen Technology Inc. to make the vectors it uses to make its T-cell transplant rejection therapy.

Cell line developer Selexis to be bought by JSR Life Sciences

14-Jun-2017 By Gareth Macdonald

JSR Life Sciences has agreed to buy cell line developer Selexis SA.

Irvine Scientific says it will build a media R&D lab at its Orange County site

14-Jun-2017 By Staff Reporter

Irvine Scientific has announced plans for an R&D centre at its site in Irvine, California citing increasing biopharma industry demand for cell culture and media regents.  

Roche accused of charging too much for Herceptin in South Africa

13-Jun-2017 By Gareth Macdonald

Roche has been accused of charging too much for its breast cancer drug trastuzumab by South African competition authorities.

Update - BioMarin to hire 50 people at Shanbally

US FDA clears BioMarin to make $380,000-a year Vimizim in Ireland

12-Jun-2017 By Gareth Macdonald

The US FDA has cleared BioMarin Pharmaceutical Inc. to make the enzyme replacement drug Vimizim (elosulfase alfa) at its plant in Cork, Ireland.

Lonza plugs EU cell and gene therapy manufacturing gap through PharmaCell buy

09-Jun-2017 By Dan Stanton

The acquisition of Dutch commercial cell and gene therapy maker PharmaCell places Lonza as the leading CDMO in the space, the firm says.

Flexing one's (bispecific) Abs: Merck ups F-star deal, EpiMab contracts WuXi

07-Jun-2017 By Staff Reporter

Germany’s Merck expands its partnership with F-star and EpimAb Biotherapeutics contracts WuXi Biologics. Welcome to our round-up of bispecific antibody news.

T Cell vaccine maker TapImmune looks to monetise expression tech

07-Jun-2017 By Dan Stanton

TapImmune says it is exploring licensing out its nucleic acid-based protein expression technology PolyStart to vaccine developers.

Horizon and ATUM combine tech to offer stable cell line production

02-Jun-2017 By Dan Stanton

Horizon Discovery will add vector and transposase technology to its gene editing services through a cross-licensing partnership with gene and protein expression services firm ATUM.

Merck KGaA taps Selexis cell line tech for immuno-oncology antibodies

31-May-2017 By Flora Southey

A Merck KGaA has signed a licensing agreement for Selexis’ SUREtechnology platform and its suspension-adapted CHO-K1 cell line.

Lithuania's Biotechpharma jumps on the 2,000L single-use seed train

30-May-2017 By Dan Stanton

 Lithuanian CDMO Biotechpharma has completed a €15m ($16.7m) expansion adding more than 2,500L of single-use bioreactor capacity.

Second time the charm for Pfizer’s Epogen biosimilar in US

30-May-2017 By Dan Stanton

An advisory committee has recommended approval of Retacrit in the US after Pfizer addressed manufacturing and clinical concerns from its first submission in 2015.

Merck rolls out cost cutting high density perfusion media

24-May-2017 By Staff reporter

Merck has launched a culture media designed to make perfusion based drug production cheaper.

JSR Corporation invests $30m in CDMO facilities

24-May-2017 By Flora Southey

JSR Corporation subsidiary KBI Biopharma is expanding its facilities in Durham, North Carolina and Boulder, Colorado, US, to respond to client needs.

A happy medium for stem cells? Irvine Scientific launches GMP xeno-free offering

17-May-2017 By Dan Stanton

Xeno-free and cGMP-manufactured media are highly desired by cell therapy developers, says Irvine Scientific as it launches a medium for hematopoietic stem and progenitor cells (HSPCs).

Takeda teams with GammaDelta to develop novel cell therapies

12-May-2017 By Gareth Macdonald

Takeda has teamed up with GammaDelta Therapeutics to develop novel T-cell-based therapies in a deal that includes an option to buy the year-old UK biotech.

Pfizer expands hemophilia gene therapy pipeline with $720m Sangamo deal

12-May-2017 By Dan Stanton

Pfizer has upped its presence in the gene therapy space through collaboration with Sangamo Therapeutics on its programmes worth up to $720m.

Amgen funds development of intracellular drugs

09-May-2017 By Flora Southey

Amgen has teamed with Feldan Therapeutics and Elasmogen in an exclusive research agreement to develop and deliver intracellular biologics.

Selexis’ Swiss investment in mammalian cell lines

09-May-2017 By Flora Southey

Selexis SA has announced its cell line development laboratory will open this week in Geneva, Switzerland.

Juno hopes to make T Cells in two days using reagents and automation tech

05-May-2017 By Dan Stanton

Juno says it is working on a set of technologies which will be able to manufacture Chimeric Antigen Receptor (CAR) T Cells within two days.

BPI Europe 2017

Cost-cutting oral vaccine tech will make Vaxart less reliant on CMO

04-May-2017 By Dan Stanton

Vaxart says its tablet delivery platform has simplified vaccine production so significantly it may bring manufacturing currently contracted to Lonza back in-house.

BPI Europe 2017

Roche on excipient inconsistencies: ‘Don’t blame suppliers, work with them’

02-May-2017 By Dan Stanton

An inconsistent lot of excipient Poloxamer 188 cut biologic yield 30%, but working with supplier BASF was key to prevent future problems, according to Roche.

DISPATCHES FROM BPI EUROPE 2017

CHO stopper? Biogen looks to alternative cell lines for future of bioproduction

28-Apr-2017 By Dan Stanton

The Chinese hamster ovary (CHO) cell line is not the future for biomanufacturing says Biogen, which will publish results from a study of alternative hosts later this year.

DISPATCHES FROM BPI EUROPE 2017

Messenger RNA a ‘game-changer’ for vaccine industry, Sanofi Pasteur

26-Apr-2017 By Dan Stanton

Sanofi Pasteur says heavy investment in messenger RNA (mRNA) is warranted as such technology could revolutionise vaccine development and manufacturing.

Samsung Bioepis to take on J&J with FDA approved Remicade biosimilar

24-Apr-2017 By Dan Stanton

Samsung Bioepis’ Renflexis has become the second biosimilar of rheumatoid arthritis biologic Remicade (infliximab) to be recommended for approval in the US.

A cracking new method: Valneva and Bavarian Nordic’s hen egg alternative

21-Apr-2017 By Flora Southey

European biotech companies Valneva and Bavarian Nordic have entered a commercial agreement to develop cell-based vaccines using production methods that are faster and cheaper than methods that use hen’s eggs. 

Synpromics announces £5.2M British investment in gene therapy tech

19-Apr-2017 By Flora Southey

Scottish synthetic biology firm Synpromics has received £5.2M ($6.6M) to enhance its synthetic promoter design technology used in gene therapy development.

1st Stem Cell Community day in Germany

For stem cells 'the process is the product,' says Pluristem

19-Apr-2017 By Dan Stanton

Manufacturing tweaks have severe effects on the quality and yield of stem cells, says Pluristem which has successfully scaled-up production through a decade of process development evolution.

Speed, yield and quality critical for cell line development, says ATUM

12-Apr-2017 By Dan Stanton

ATUM has launched itself into the mammalian cell line development space after being awarded patents for its Leap-In transposase genome technology.

Sanfilippo syndrome gene therapy could be filed in US next year, Abeona

11-Apr-2017 By Dan Stanton

Abeona Therapeutics says it plans to file its single injection adeno-associated virus (AAV) gene therapy for Sanfilippo syndrome in the US in late 2018.

GE Healthcare teams with CBMG to develop CAR-T and stem cell production tech

11-Apr-2017 By Gareth Macdonald

GE Healthcare has agreed to help Cellular Biomedicine Group (CBMG) develop CAR-T and stem cell production technologies to support its aim of making 10,000 cancer cell therapies a year. 

Sumitomo Dainippon buys cell therapy processing tech from Hitachi

10-Apr-2017 By Gareth Macdonald

Sumitomo Dainippon Pharma Co Ltd has ordered cell culture technologies from Hitachi as part of its effort to develop a treatment for Parkinson’s disease.

Selling cell thawing: Medcision launches early adopter scheme to push tech

07-Apr-2017 By Gareth Macdonald

Medcision has started pushing its cell therapy thawing technology through an early adopter scheme designed to encourage adoption by firms with candidates in trials.