Cell lines

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.

Viral vector manufacturing collaboration generates ‘tangible value’

27-Jun-2019 By Vassia Barba & Maggie Lynch

Cobra and Symbiosis announce the completion of their collaboration on viral vector development and manufacturing, supported by £1.9m Innovate UK grant.

Sartorius’ $100m Puerto Rico expansion enables greater supply for US industry

26-Jun-2019 By Maggie Lynch

Sartorius’ investment in Puerto Rico site doubles production capacity of manufacturing equipment for the biopharmaceutical industry.

‘Miniaturized’ vaccine production line to be adapted for M&R program

25-Jun-2019 By Maggie Lynch

After a grant from the Bill & Melinda Gates Foundation, Univercells will adapt its low-footprint, cabinet-contained vaccine production line to create affordable measles and rubella vaccinations.

Fujifilm Diosynth COO on industry ‘buzz’ for cell therapies

24-Jun-2019 By Vassia Barba

Fujifilm Diosynth has developed its ability to transition products from research to GMP, answering a big challenge as more parties look to get involved in the space, says COO.

Second biosimilar from Amgen and Allergan approved by FDA

19-Jun-2019 By Maggie Lynch

Amgen’s biosimilars portfolio reaches a milestone after its Herceptin biosimilar, Kanjinti, developed in collaboration with Allergan, was approved by the US FDA.

CAR-Ts that grow on trees: Automating cell therapy manufacturing

11-Jun-2019 By Vassia Barba

As the cell and gene therapies market evolves, CDMOs and pharmaceutical companies aim to adapt to the rising demands and serve larger patient populations.

Fujifilm in $10m investment for continuous bioprocessing facility

11-Jun-2019 By Ben Hargreaves

Utilising single-use flow paths, Fujifilm will create a continuous bioprocessing manufacturing facility after three years of in-house development.

WuXi ploughs ahead with ‘world’s largest’ single-use facility

11-Jun-2019 By Ben Hargreaves

WuXi Biologics has selected its construction partner, Jacobs, for the building stage of its ‘Factory of the Future’ facility in Dundalk, Ireland.

Yposkesi signs with Servier to manufacture allogenic CAR-T

11-Jun-2019 By Maggie Lynch

Servier to work with Yposeski for the production of lentiviral vectors, as the former works to develop allogenic CAR-T cell technology for hematological therapies.

Aldevron ‘robust’ expansion ups biologics capacity by 10x and triples workforce

06-Jun-2019 By Ben Hargreaves

Aldevron announces the expansion of its headquarters’ campus by half a million-square-feet, which will see annual capacity exceed $1bn of biologic products.

Fujifilm opens office in biotech hub to develop research relationships

06-Jun-2019 By Maggie Lynch

Fujifilm Life Science Strategic Business Office will open a site in Cambridge, Massachusetts in an aim to further link up with the surrounding pharmaceutical and biotech community.

Centrifuge to enable scalability launched through Thermo Fisher partnership

05-Jun-2019 By Maggie Lynch

Thermo Fisher and Scinogy partner to improve scalability and cost-effectiveness of cell and gene therapy manufacture through the addition of the former’s centrifuge.

First fill-finish service from iBio aims to accelerate movement to the clinic

04-Jun-2019 By Maggie Lynch

To get biologics to market faster, iBio launches sterile fill-finish operations for preclinical and clinical biologic products.

Iovance builds gene therapy manufacturing facility in Philadelphia

30-May-2019 By Maggie Lynch

Iovance amps up clinical and commercial immunotherapy production with a $75m (€67.3m), 136,000 square-foot build in Philadelphia’s Navy Yard.

GSK’s shingles vaccine approved in China

29-May-2019 By Maggie Lynch

GSK is investing in ‘significant’ capacity expansion to support production of its shingles vaccine, which has been approved in China after clinical trials demonstrated 90% efficacy.

A ‘truly translational mindset’ requires the correct tool for the correct job: Synlogic

29-May-2019 By Maggie Lynch

Translational research faces new challenges – and opportunities – with the rapid growth in precision medicine and new drug modalities, as the industry looks to quickly bring new treatments to patients.

Cel-Sci’s arthritis vaccine ‘reprogramming’ the immune system

29-May-2019 By Vassia Barba

Cel-Sci’s rheumatoid arthritis treatment, developed under an $1.5m NIH grant, will be featured at the BIO Convention in Philadelphia next week.

SGS’ Glasgow biosafety facility doubles in size

28-May-2019 By Maggie Lynch

SGS’ completed the ₤8.7m expansion of its large molecule testing facility in Glasgow and made room to increase its existing biosafety service and PCR platform capabilities.

Lonza adopts Synpromics’ inducible promoters, expands bio manufacturing platform

22-May-2019 By Vassia Barba

Lonza and Synpromics move on to the commercialization of a number of inducible promoters to expand the former’s manufacturing offerings.

WuXi Biologics to build 1.3m-sq-ft manufacturing centre

16-May-2019 By Ben Hargreaves

WuXi Biologics announces its latest expansion, with plans for a drug development and commercial manufacturing site with a potential bioreactor capacity of 144,000L.

Bayer invests $150m to expand its biologics development

14-May-2019 By Ben Hargreaves

Bayer will build a 40,000-square-foot cell culture facility to bolster its capacity to develop therapies primarily focused on oncology and cardiology.

Merger looks to create bacteriophages to counter antibiotic resistance

14-May-2019 By Maggie Lynch

AmpliPhi Biosciences and C3J Therapeutics merge to focus on the development of phage-based therapeutic candidates for antibiotic resistance.

Extended indication of mAb provides asthma relief

08-May-2019 By Maggie Lynch

Dupixent, Regeneron and Sanofi’s collaborative mAb treatment for eczema, has been approved by the European Commission for a new indication in severe asthma.

Merck bumps up production of MMR vaccine amid measles outbreak

08-May-2019 By Maggie Lynch

With the recent outbreak of measles in the US, the only MMR vaccine producer in the US, Merck, has increased its production to meet demand.

Kite gets freedom to fly after separation from Gilead

08-May-2019 By Vassia Barba

Gilead’s new CEO unties Kite as an independent business unit to give Yescarta’s manufacturer more autonomy in the biotech sky.

GSK’s lupus treatment receives FDA approval for treating pediatric patients

07-May-2019 By Maggie Lynch

The US FDA approves an extended indication of GSK’s lupus treatment, Benlysta IV, for children five years and older, giving pediatric patients a new therapeutic option.

Wacker Bio licenses its E. coli based production strain to PhaseBio

06-May-2019 By Maggie Lynch

Wacker licenses E. coli based production strain to PhaseBio for the manufacture of antibody fragment.

‘No longer science-fiction’: Evolutions and applications of cell & gene therapies

06-May-2019 By Maggie Lynch

According to an industry expert, gene therapy must move rapidly to address unmet needs and will continue to do so given innovation and investments.

Poseida raises $142m in Series C financing to advance CAR-T products

25-Apr-2019 By Maggie Lynch

Poseida Therapeutics raises $142m in Series C financing round led by current marketer of CAR-T therapy Kymriah, Novartis.

Infant death in trial yet Novartis anticipates no threat to approval

24-Apr-2019 By Maggie Lynch

Novartis investigates the death of an infant in a gene therapy clinical trial to determine whether it was related to the treatment but does not anticipate an impact on FDA approval.

GeneDesign opens large-scale production facility in Osaka

23-Apr-2019 By Vassia Barba

The Ajinomoto subsidiary opens a development and production base for oligonucleotide drug substances in Japan.

T cell boosting therapy expands into oncology

23-Apr-2019 By Maggie Lynch

US FDA grants orphan drug designation for Hyleukin-7, an immuno-oncology agent that boosts T cell production and functionality, for the treatment of ICL.

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