Cell lines

‘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.

Q&A

Cryoport’s CEO on cell therapies’ market ‘robust demand’

22-Apr-2019 By Vassia Barba

The expanding cell therapy market has placed new demands on supply chain services, with their shipment requirements and competition in the logistics industry rising.

WuXi and I-Mab extend partnership to accelerate biologic development

18-Apr-2019 By Maggie Lynch

I-Mab and WuXi Biologics extend their strategic partnership for biologics process development as well as clinical and commercial manufacturing to accelerate drug development in China and abroad.

Kiadis gains NK-cell technology for immunology therapies through CytoSen acquisition

17-Apr-2019 By Maggie Lynch

Kiadis Pharma acquires CytoSen Therapeutics and gains NK-cell technology capabilities to complement its own T-cell platform.

Catalent’s $1.2bn Paragon deal sign of booming gene therapy market

16-Apr-2019 By Ben Hargreaves & Vassia Barba

Catalent to acquire Paragon and plans “substantial capital investments” to ensure Paragon’s further growth, the latest deal in a busy area.

Selexis’ biologic platform generates first-ever approved Soliris biosimilar

11-Apr-2019 By Maggie Lynch

First-ever Soliris biosimilar approved in Russia after it was produced through Selexis’ SureTechnology platform and cell line.

Bluebird ramps up lentiviral vector production with Durham Facility

10-Apr-2019 By Maggie Lynch

Bluebird bio opens its first wholly owned manufacturing facility to produce lentiviral vectors for the company’s investigational gene and cell therapies.

EU approval for Teva’s quarterly dosed migraine drug

09-Apr-2019 By Maggie Lynch

Teva’s anti-CGRP migraine drug lines up next to its competitors as the European Commission grants it marketing authorization.

Transgene and BioInvent extend OV development for solid tumor collaboration

09-Apr-2019 By Maggie Lynch

Transgene and BioInvent will extend their collaboration to co-develop multi-functional oncolytic viruses for the treatment of solid tumors.

Abzena creates offering for drug candidate optimization

29-Mar-2019 By Maggie Lynch

Abzena launches a developability assessment and optimization service to assist customers in selecting and developing lead candidates for manufacture.

Fujifilm Irvine Scientific launches insect cell media for viral vectors

29-Mar-2019 By Ben Hargreaves

Fujifilm Irvine Scientific announces low hydrolysate medium for use in insect cell expression systems.

Brammer acquisition bolsters Thermo Fisher place in the market

29-Mar-2019 By Maggie Lynch

Thermo Fisher’s $1.7bn acquisition bolsters its ‘already strong position’ in the cell and gene therapy market, with increased CDMO capabilities.

Merck extends research agreement for NASH drug candidate

27-Mar-2019 By Maggie Lynch

Merck exercises its option to extend research phase with NGM for an additional two-year period, moving the collaboration end date to March 2022.

Biologic manufacturing: Quality and efficacy lead to cost-effectiveness

26-Mar-2019 By Maggie Lynch

Biologics come with a hefty price tag, both to patients and manufacturers, but cost-effectiveness may be obtained through quality assurance.

Thermo Fisher acquires gene therapy CDMO Brammer Bio

25-Mar-2019 By Maggie Lynch

Thermo Fisher Scientific bolsters its gene therapy capabilities by acquiring Brammer Bio for $1.7bn, as the market becomes an ‘increasing focus’ for customers.

Abzena tapped as CMC for Lipum’s biologic development project

20-Mar-2019 By Maggie Lynch

Abzena and Lipum enter agreement for the development of biologics for juvenile idiopathic arthritis, using the former’s proprietary cell line and GMP resources.

Takeda’s plasma manufacturing facility approved by FDA

20-Mar-2019 By Maggie Lynch

US FDA approves Takeda’s acquired plasma manufacturing facility in Georgia, US, for the production of flexbumin 25% solution.

First oncology mAb biosimilar from Pfizer approved by FDA

14-Mar-2019 By Maggie Lynch

US FDA approves Pfizer’s Trazimera, a biosimilar to Roche’s blockbuster product, Herceptin, for the treatment of HER2 positive breast cancer.

‘Can you manufacture consistently?’ The big question in regenerative medicine

11-Mar-2019 By Ben Hargreaves

Regenerative medicine raised $13.3bn in funds during 2018 but investors question whether treatments can be manufactured consistently, according to AMR annual report.

Kite collaborates to increase efficiency of CAR-T manufacture

07-Mar-2019 By Ben Hargreaves

MaxCyte announces a partnership with Kite to explore the use of flow electroporation technology to enable the non-viral cell engineering of CAR-T drug candidates.

GE Healthcare working ‘two to three years’ ahead anticipating manufacturing advances

06-Mar-2019 By Ben Hargreaves

The rapid evolution of cell and gene therapy technology is leading GE Healthcare to explore partnerships to meet increasing manufacturing demand, according to the company's enterprise solutions leader.