Cell lines

Cobra flags successful production of plasmids for epilepsy targeted gene therapy

30-Jun-2021 By Jane Byrne

Cobra Biologics, the gene therapy division of the Charles River owned Cognate BioServices, and Sweden's CombiGene recently announced the successful production and quality assurance of the plasmids to be used in the GMP production of the gene therapy,...

ViaCyte reports positive cell replacement result for diabetes

29-Jun-2021 By Ben Hargreaves

The company publishes results showing positive preliminary data for its islet cell replacement therapy for type 1 diabetes.

Genezen breaks ground on cGMP lentiviral vector production facility

28-Jun-2021 By Jane Byrne

Genezen Laboratories, Inc, a US cell and gene therapy contract development and manufacturing Organization (CDMO) is set to build a 75,000+ square foot cGMP-compliant lentiviral vector production facility in Indianapolis.

Clean Biologics gains foothold in North American market, adds vaccine and biologics focused CDMO to group

05-May-2021 By Jane Byrne

French pharma services provider, Clean Biologics, has acquired Canadian CDMO, Biodextris, in a move it says will boost its analytical and process development, and early-phase clinical manufacturing and quality control testing services for clients in the...

Takara Bio in stem cell licensing deal aimed at supporting cell-based therapy R&D for diabetes

05-May-2021 By Jane Byrne

Takara Bio Europe has announced a licensing agreement with Denmark’s PanCryos, a pre-clinical stage biotech company, for its clinical-grade human embryonic stem (hES) cell lines, starting material for cell therapy development.

Membranes unlock potential to increase cell-free vaccine production

22-Apr-2021 By Jane Byrne

Synthetic biologists based at Northwestern University in the US have discovered a new way to increase production yields of protein-based vaccines five-fold, significantly broadening access to potentially lifesaving medicines.

UK deal sees consolidation of two players in the iPSC space

18-Mar-2021 By Jane Byrne

Axol Biosciences, a UK provider of human induced pluripotent stem cells (iPSC) derived cells, media, and characterization services, has merged with Scotland based, Censo Biotechnologies, a cell biology CRO with expertise in iPSC-related technologies.

New antibody discovery platform could help accelerate CAR-T therapeutic development

12-Jan-2021 By Jane Byrne

UK biotech, OXGENE, says its SLIM platform for discovery of antibodies against membrane proteins in their native configuration in mammalian cells could support CAR-T therapeutics.

UK biotech in licensing deal with BMS on antibodies screening tool

13-Oct-2020 By Jane Byrne

IONTAS has announced a deal with Bristol Myers Squibb (BMS) in relation to its platform for antibody identification.

Fujifilm Irvine Scientific takes on distribution of substrate that supports cell therapy research

30-Sep-2020 By Jane Byrne

Fujifilm Irvine Scientific has become the exclusive, worldwide distributor of cellnest, a recombinant peptide attachment substrate that is said to provide optimal adhesion and proliferation of stem cells in chemically defined, animal component-free conditions.

Thermo Fisher addresses the growing need for more flexible, scalable biologics development

15-Sep-2020 By Jane Byrne

Thermo Fisher Scientific has opened a new bioprocessing collaboration center (BCC) adjacent to its biologics manufacturing facility in St Louis, Missouri.

Novavax receives record $388m funding for COVID-19 vaccine

12-May-2020 By Ben Hargreaves

CEPI awards Novavax highest investment to date, with the biotech progressing candidate into trials and partners with Emergent for production.

How to prevent another COVID-19? ‘Invest in infrastructure’

06-May-2020 By Ben Hargreaves

CEO of Berkeley Lights talks about the company’s work to identify antibodies against COVID-19 and what the long-term picture looks like.

Mogrify and Sangamo in license agreement for ‘off-the-shelf’ CAR-Treg

23-Apr-2020 By Ben Hargreaves

Sangamo plans to utilize Mogrify’s cell conversion technology to develop CAR-Treg cell therapies.

Lab discovery could allow for heparin produced by cell lines

16-Apr-2020 By Ben Hargreaves

Researchers from UC San Diego identify a critical gene in the heparin biosynthesis process, which could pave the way for future industrial production.

Vir continues to build production for COVID-19 antibody

14-Apr-2020 By Ben Hargreaves

In its latest manufacturing partnership, Vir announces that it will work with Samsung Biologics for large-scale production.

Daiichi pays $225m to access gene therapy production platform

06-Apr-2020 By Ben Hargreaves

Daiichi partners with Ultragenyx to utilize its HeLa producer cell line platform for commercial-scale gene therapy production.

Avectas partners with Vycellix to speed cell therapy production

31-Mar-2020 By Ben Hargreaves

The partners will combine expertise to progress the novel RNA immunomodulator, VY-M.

GE Healthcare anticipates demand with Swiss facility investment

23-Jan-2020 By Ben Hargreaves

GE Healthcare reacts to the number of regenerative medicine companies operating globally by announcing plans for a facility to create single-use kits and advanced therapies.

CPhI Worldwide 2019

Early monitoring key to countering variability in bioproduction

14-Nov-2019 By Vassia Barba

Regardless of the quality of the raw materials used in bioproduction processes, variability is a very common threat that can be addressed, says Thermo Fisher executive.

Automating cell and gene therapy manufacture ‘has to be accelerated’, says Lonza CEO

04-Nov-2019 By Ben Hargreaves

Marc Funk explains how the company is ensuring it has the right people in place to move advanced therapies forward and into the future of manufacture.

GSK adopts Lyell’s services to improve T cell ‘fitness’

10-Oct-2019 By Vassia Barba

GSK taps Lyell’s technology to delay ‘exhaustion’ of T cells and will explore creating a new platform to develop cell and gene therapies for rare cancers.

Lonza in deal to manufacture Cellectis’ UCART oncology pipeline

03-Oct-2019 By Vassia Barba

Cellectis chooses Lonza to take on the clinical manufacturing of its UCART blood cancer immunotherapy candidates, intended to be marketed as industrialized, readily available CAR-T cells.

NEWS IN BRIEF

Glenmark opts for Horizon’s gene edited cell lines

01-Oct-2019 By Ben Hargreaves

Glenmark signs a full commercial license to utilize Horizon’s gene edited CHO cell lines to be added to the former’s biomanufacturing process.

Nordic Life Science Days

Cell selection algorithm turns medical waste into treatment

27-Sep-2019 By Vassia Barba

NextCell’s development platform enables the selection of specific stem cells in order to create a treatment with various potential indications.

Genome editing allows for ‘faster, simpler’ CHO cell lines

03-Sep-2019 By Ben Hargreaves

As MilliporeSigma expands its patent portfolio for its genome editing technology, the company’s head of strategy discusses how CRISPR is changing the bioproduction landscape.

908 Devices launches a Rebel-lion in media analyzing

03-Sep-2019 By Vassia Barba

908 Devices launches Rebel, a bioprocess analyzer, enabling researchers to conduct their own cell culture media analysis to accelerate process development ‘by weeks’.

IND approval gives celiac patients possibility to eat gluten

29-Aug-2019 By Maggie Lynch

The FDA approves an IND application from ActoBio for AG017, an oral biologic drug candidate for the reversal of celiac disease, a condition which currently has no approved treatments.

Alligator enters China’s ‘advancing’ market through licensing agreement

28-Aug-2019 By Maggie Lynch

Alligator grants Biotheus rights to an antibody for the creation of three bispecific molecules in the Greater China region.

Packager limits intra-facility travel to address ‘critical out-of-cold-storage time’

22-Aug-2019 By Maggie Lynch

Contract packaging provider Reed-Lane adds dedicated room for vial and ampule kitting to its cold chain capabilities to limit intra-facility travel and product excursion as a means of security.

Merck collaborates to examine Keytruda in combination with investigational drug

15-Aug-2019 By Maggie Lynch

Merck enters a clinical collaboration agreement with Oncologie to evaluate the combination of investigational drug Bavituximab and Keytruda in cancer patients.

EMA tells companies to declare peptone use in biologics fermentation

14-Aug-2019 By Nick Taylor

The European Medicines Agency (EMA) tells manufacturers that use fish peptone in fermentation to declare the ingredient.

Sanofi warns of delays to flu vaccine shipments

13-Aug-2019 By Nick Taylor

Sanofi warns that the World Health Organization’s delayed strain selection will push back the date on which it delivers vaccines for the 2019-2020 flu season.

Bayer acquires cell therapies developer BlueRock

13-Aug-2019 By Vassia Barba

Bayer to fully acquire BlueRock Therapeutics’ to build its cell therapy pipeline based on the latter’s induced pluripotent stem cell platform.

Regenerative medicines global revenues down by 40% but ‘poised for growth’

12-Aug-2019 By Vassia Barba

The global market for regenerative medicines raised $4.8bn in the first half of 2019; a slowdown compared to the same period of 2018, though the sector is poised for additional growth, says ARM CEO.

BMS leases biologic development space in New Jersey to PTC

08-Aug-2019 By Maggie Lynch

Bristol-Myers Squibb and PTC Therapeutics enter a long-term lease agreement giving the latter greater access to biologic production facility as it advances its treatments for rare genetic disorders.

Pfizer ramps up bioprocessing capacity for DMD gene therapy trial

08-Aug-2019 By Nick Taylor

Ahead of the start of a Phase III clinical trial, Pfizer ramps up manufacturing capacity for its Duchenne muscular dystrophy (DMD) gene therapy.

July roundup sees flurry of partnership deals

29-Jul-2019 By Ben Hargreaves

The summer months are traditionally slow on movements across the industry, but July saw a number of manufacturing partnership deals take place as companies look ahead to product commercialization.

UK cell and gene manufacturing employment increases by 30%

19-Jul-2019 By Ben Hargreaves

CGT Catapult reports that employment has increased substantially, and production capacity has grown by 60% in the UK cell and gene therapy manufacturing industry.

Novartis and Catalent enter agreement to manufacture SMA gene therapy

18-Jul-2019 By Maggie Lynch

Catalent Biologics works with Novartis to develop and manufacture its SMA gene therapy treatment and provide manufacturing capacity, as the treatment enters the market.

NIH signs on IDT Biologika to manufacture clinical trial supply

16-Jul-2019 By Maggie Lynch

The NIH has contracted IDT Biologika to manufacture five E. coli master cell banks for BLA, IND, and Phase I/II trial supply.

Wacker Chemie turns to biopharma during period of uncertainty

12-Jul-2019 By Ben Hargreaves

Wacker Biotech looks to corner the microbial expression system niche, as Wacker Chemie’s traditional areas of focus face difficult market conditions.

Paragon’s Maryland facility adds Passage Bio’s manufacturing suite

11-Jul-2019 By Maggie Lynch

Paragon and Passage Bio enter a collaboration agreement to develop a dedicated manufacturing suite at the former’s Maryland facility, as the latter’s gene therapy candidates enter the clinic.

Bayer invests $215m as Century advances cell therapy programs

09-Jul-2019 By Maggie Lynch

Century Therapeutics advances its allogeneic cell therapy platform created programs to the clinic after a $250m in financing led by Bayer.

Working against the ‘hard’ vaccines with patient capital

08-Jul-2019 By Vassia Barba

Vaccine research is still quite ‘empirical’ and there is a long way until it is turned into a rational, predictable modality, suggests director at the Bill and Melinda Gates Foundation.

Regeneron and Sanofi’s PD-1 inhibitor given go-ahead by EC

04-Jul-2019 By Maggie Lynch

Regeneron and Sanofi’s Libtayo is granted marketing authorization by the European Commission for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma.

FDA should improve incentives to lower drug costs, says Dyadic CEO

02-Jul-2019 By Vassia Barba

The FDA needs to expedite the approval process to provide incentives for the development of more affordable drugs, says Dyadic CEO.

FDA approves Pfizer’s oncology mAb biosimilar Zirabev

02-Jul-2019 By Maggie Lynch

Avastin biosimilar from Pfizer receives approval from the FDA for the treatment of five forms of cancers, increasing market competition for the originator drug.

Amicus picks Brammer for preclinical, clinical gene therapy work

02-Jul-2019 By Vassia Barba

Rare disease drug developer to work with Brammer Bio – which Thermo Fisher acquired in March – on gene therapy programs against Batten disease.

Catalent bolsters Paragon through Novavax deal

02-Jul-2019 By Vassia Barba

Aiming to boost the gene therapy development and manufacturing capabilities of Paragon, which Catalent acquired in April, the CDMO has agreed to acquire all of the gene therapy-related assets from Novavax, a late-stage vaccine developer.