Cell lines

Horizon licenses ‘copy and paste’ tech to optimise commercial cell line

13-Feb-2018 By Flora Southey

Horizon’s gene editing technology will be used by a US immuno-oncology firm to make a cell line for commercial use.

Denali signs Lonza to make biologics in first CMO deal

12-Feb-2018 By Flora Southey

Lonza has inked a biologics deal with Denali to make neurodegenerative disease therapies, offering the Californian firm opportunity to have production “on their back doorstep.”

Cryoport wins TiGenix logistics contract and braces for CAR T roll out

09-Feb-2018 By Staff Reporter

Cryoport will provide cold chain logistics to TiGenix as it conducts phase Ib/IIa allogeneic adipose‐derived stem cells for the treatment of sepsis.

Q&A

AbSci hopes to make E. Coli great again through engineered expression system

07-Feb-2018 By Dan Stanton

AbSci says its genetically engineered E. coli expression platform has produced yields exceeding 20 g/L for difficult to express products and threatens the dominance of mammalian systems.

Making an HIV cure: AGT completes process development for T-cell therapy

06-Feb-2018 By Dan Stanton

American Gene Technologies International (AGT) says its HIV candidate is ‘the most complex cell therapy the industry has delivered to date.’

Adaptimmune begins in-house T-cell therapy manufacture at PA plant

06-Feb-2018 By Staff Reporter

Adaptimmune Therapeutics has manufactured the first SPEAR-T cells for a patient at its Navy Yard facility, which will be the primary site for its future manufacturing requirements.

Sanofi to buy Ablynx for €3.9bn, leaving Novo Nordisk in the cold

29-Jan-2018 By Dan Stanton

Sanofi is set to acquire its antibody-fragment tech partner Ablynx for €3.9bn ($4.8bn).

Sanofi to pay $11.6bn for Bioverativ for haemophilia biz and commercial network

23-Jan-2018 By Gareth Macdonald

Sanofi has agreed to buy Bioverativ Inc. for $11.6bn for haemophilia business and to help develop its candidate RNAi therapeutic fitusiran.

Celgene buying T-cell tech partner Juno for $9bn

23-Jan-2018 By Dan Stanton

Celgene will add chimeric antigen receptor (CAR) and T-cell receptor (TCR) technologies through the acquisition of its immune-oncology partner Juno Therapeutics.

Cellular Biomedicine Group adopts GE Healthcare tech for CAR-T therapy production

19-Jan-2018 By Gareth Macdonald

Cellular Biomedicine Group Inc (CBMG) has selected GE Healthcare’s FlexFactory technology for its CAR-T therapy production facility in Shanghai, China.

Google Ventures and others back universal flu vaccine firm Vaccitech

17-Jan-2018 By Gareth Macdonald

Vector-based vaccine tech firm Vaccitech has secured £20m ($27.1m) in venture capital with investors Google Ventures, Sequoia China, Neptune Ventures and Oxford Sciences Innovation.

Product characterisation key to successful CAR T therapies, Autolus

16-Jan-2018 By Dan Stanton

CAR T-cell understanding must come before the process design if such therapies are ever going to be accessible to a larger patient population, says Autolus.

Sartorius inks deal for Quad's T cell activation tech

12-Jan-2018 By Dan Stanton

Quad Technologies has teamed with Sartorius Stedim Biotech to expand the reach of its T-cell activation reagent for cell and gene therapy production.

Takeda set to buy stem cell therapy partner TiGenix for $620m

09-Jan-2018 By Dan Stanton

Takeda has said it will review the manufacturing of Alofisel (darvadstrocel) if its €520m ($620m) bid for off-the-shelf stem cell developer TiGenix is successful.

Pfizer invests in mAb discovery with Berkeley Lights’ Beacon tech

05-Jan-2018 By Flora Southey

Pfizer has selected Berkeley Lights’ workflow platform to advance its monoclonal antibody discovery and gene editing programmes.

Takeda's off-the-shelf stem cell therapy closes in on EU approval

19-Dec-2017 By Dan Stanton

The EMA has recommended approval of the first ever off-the-shelf stem cell therapy, Takeda and Tigenix’s Alofisel (darvadstrocel).

Big batches, big margins: Reneuron on off-the-shelf stem cells

15-Dec-2017 By Dan Stanton

Difficulty in scaling-up autologous cell therapies means margins are low says Reneuron, which is focused on off-the-shelf stem cell products.

UPDATE

CMC Biologics to make Harpoon’s cancer drugs in California, US

15-Dec-2017 By Flora Southey

Harpoon Therapeutics has selected CMC Biologics to develop and manufacture three molecules for cancer treatments at the CDMO’s facilities in California and Washington State, US.

Teva picks Beacon, brings antibody development to light in Australia

14-Dec-2017 By Flora Southey

Teva Pharmaceuticals Australia has selected Berkeley Lights’ biological workflow platform to develop therapeutic antibodies at its R&D site in New South Wales.

Microbial systems, fill/finish or vaccines? Avid eyeing up bolt-on services

13-Dec-2017 By Dan Stanton

Avid Bioservices says it is looking to expand its biomanufacturing offering as it transitions into a pure-play CDMO from Peregrine Pharmaceuticals.

Cell Therapy Manufacturing & Gene Therapy Congress

Kite talks audits, training and dry runs across CAR T supply chain

12-Dec-2017 By Dan Stanton

CAR T developers must be involved throughout the entire supply chain says Kite Pharma, which depends on accreditation and training programmes across its network of Yescarta administration clinics.

Gilead buying Cell Design Labs for $567m in further CAR T boost

08-Dec-2017 By Staff Reporter

Months after jumping into the cell therapy space through the $11.9bn acquisition of Kite, Gilead has agreed to buy CAR T tech firm Cell Design Labs.

Cell Therapy Manufacturing & Gene Therapy Congress

Regulatory approvals and innovation drives: Cell therapies come of age

06-Dec-2017 By Dan Stanton

Cell therapies have reached their 'teenage years' and must now overcome processing efficiencies and quality struggles, say industry delegates.

Vaccinex and Catalent team on cancer ADC development

05-Dec-2017 By Dan Stanton

The deal will see Vaccinex combine its antibody optimisation platform with Catalent’s conjugation and cell line engineering technologies.

Bluebird buys NC manufacturing site but will continue to use CMOs

29-Nov-2017 By Dan Stanton

Bluebird bio has acquired a North Carolina manufacturing facility to produce lentiviral vectors for its cell and gene therapy candidates.

Thermo Fisher suggests bio-researchers order before 2018 price hike:

29-Nov-2017 By Staff Reporter

Thermo Fisher will up its list prices by an average of 3.3% across much of its early-stage bioproduction product range, reflecting changing market conditions.

ADC Bio: Industry unprepared for aggregation risk of next-generation ADCs

22-Nov-2017 By Dan Stanton

Antibody-drug conjugate (ADC) developers are at risk of aggregation issues caused by the hydrophobic nature of next-generation linker-payloads, says ADC Bio.

InVitria launches xeno-free formulation service within $5.2bn media market

10-Nov-2017 By InVitria launches xeno-free service within $5.2bn media market

Xeno-free media will continue to increase its share of the estimated 30m litre mammalian cell culture market says InVitria, which has launched a new formulation service.

Samsung BioLogics extends supply agreement with MilliporeSigma

08-Nov-2017 By Dan Stanton

Samsung BioLogics has extended a memorandum of understanding with MilliporeSigma for supply of single-use systems and bioprocessing raw materials.

Swiss CDMO to expand newly bought Glycotope biomanufacturing plant in Germany

07-Nov-2017 By Dan Stanton

Celonic says it will immediately begin expanding the former Glycotope site in Heidelberg, Germany adding two 2,000L single-use bioreactors.

Juno: Centralised approach key to manufacturing CAR T therapies

03-Nov-2017 By Dan Stanton

Heavy investment in quality control, quality assurance and dedicated equipment is likely to keep CAR T-cell manufacturing in-house, says Juno Therapeutics.

Infographic

Bioprocessing survey report: Is the CHO CHO train slowing down?

03-Nov-2017 By Dan Stanton

Nearly half the respondents of our second state of the global biomanufacturing survey believe we are too reliant on Chinese Hamster Ovary (CHO) expression systems.

ProBioGen to make ADCC-enhanced cancer stem cell mAb for Chiome

24-Oct-2017 By Flora Southey

Chiome Bioscience has selected ProBioGen to develop and manufacture its monoclonal antibody LIV-1205, which is designed to combat liver cancer and solid tumours.

Univercells: 'Micro-facilities' to slash the cost of vaccine manufacture

20-Oct-2017 By Cutting the cost of vaccine manufacture, Univercells

High-density single-use bioreactors, small facilities and continuous manufacturing will cut the cost of manufacturing polio vaccines down to $0.15 per dose, says Univercells.

Gilead ramping up CAR T clinics after US FDA Yescarta approval

20-Oct-2017 By Dan Stanton

Gilead says it is looking to make as many as 90 academic centres available to administer CAR-T Yescarta (axicabtagene ciloleucel) following its approval in the US.

'Luxturna' recommendation good for all AAV based gene therapies says advocacy group

18-Oct-2017 By Gareth Macdonald

The US approval recommendation for Spark Therapeutics’ blindness gene therapy voretigene neparvovec is also an endorsement of AAV delivery technologies according to the Alliance for Regenerative Medicine.

VirionHealth secures Abingworth backing to trial novel antiviral studies

17-Oct-2017 By Gareth Macdonald

VirionHealth Ltd is poised to start Phase I trials of new biological antivirals - called defective interfering particles - after receiving £13m ($15m) from private equity group Abingworth.

Batavia adding 50 jobs in US viral vector and EU cleanroom expansion

17-Oct-2017 By Dan Stanton

Batavia Biosciences will expand a Dutch production facility and build a viral vector plant in the US to cater for demand for its bioprocessing services.

Selexis says KBI collaboration offers ‘gene to GMP’ in 10 months

13-Oct-2017 By Dan Stanton

Pelican Therapeutics has teamed with Selexis and sister CMO KBI Biopharma to advance two monoclonal antibody candidates.

Cut price Kymriah? ThermoGenesis thinks so with automated CAR-T tech

10-Oct-2017 By Dan Stanton

ThermoGenesis says it can reduce the cost of making CAR-T cell therapies five-fold through its recently acquired automated tech platform.

The tech behind the first FDA-approved CAR-T cell therapy

03-Oct-2017 By Melissa Fassbender

To develop the first-FDA approved CAR-T immunotherapy, Novartis used Thermo Fisher’s proprietary cell therapy systems (CTS) Dynabeads technology.

Biotech says its vaccines target and kill cancer cells, with fewer side effects

03-Oct-2017 By Flora Southey

OncoQR says its two-part therapeutic vaccines help the immune system to attack cancerous cells more effectively and with fewer side effects than conventional immunotherapies.

MilliporeSigma opens Chinese bioprocessing centre to showcase tech

27-Sep-2017 By Staff Reporter

MilliporeSigma has opened a biopharma process development and technology centre in China.

US FDA stem cell enforcement challenged by state legislation

20-Sep-2017 By Dan Stanton

State legislation allowing unapproved stem cell treatments could undermine efforts by the US FDA to clampdown on unregistered clinics.

Bayer takes a shine to Berkeley Light's Beacon biologics workflow tech

19-Sep-2017 By Dan Stanton

Bayer has signed a deal to use Berkeley Lights’ automated biological workflow platform for cell line development and antibody discovery.

Synpromics expansion to support growing gene control business

19-Sep-2017 By Dan Stanton

Moving to a larger facility will help Scottish firm Synpromics Ltd increase its gene control and cell line services presence, the firm says.

US FDA approves Amgen and Allergan's Avastin biosimilar

15-Sep-2017 By Gareth Macdonald

US regulators have approved Amgen Inc’s Mvasi (bevacizumab-awwb), a biosimilar version of Roche’s monoclonal antibody (mAb) cancer treatment Avastin (bevacizumab). 

Microtissue magic: 3D-printed tech for cell culture production 'degrades on demand'

14-Sep-2017 By Flora Southey

Researchers at Brown University have developed a 3D printing technique which they say could be used to make cell cultures for biopharmaceutical production.

Expression yourself: Win an iPad in our bioprocessing survey

12-Sep-2017 By Dan Stanton

Is plastic fantastic? Is stainless still à la mode*? Do Chinese hamsters continue to tow the cell line? Biopharma-Reporter wants your opinions for its second annual biomanufacturing survey.

Update

Spain OKs TiGenix's bigger cell therapy plant as firm preps for Cx601

06-Sep-2017 By Gareth Macdonald

Spain has licensed TiGenix NV's expanded Madrid plant paving the way for a potential European launch of Cx601, its cell therapy for the Crohn's disease complications.