Cell lines

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.

Nightstar acquired by Biogen for $800m

05-Mar-2019 By Maggie Lynch

Biogen agrees Nightstar acquisition for $800m to take on its pipeline of AAV treatments for retinal disorders, diversifyingy its pipeline in the rare disease market.

Global cell line development market to reach $7.5bn by 2024

01-Mar-2019 By Maggie Lynch

The global cell line development market grows steadily with a predicted revenue of $7.5bn by 2024, each component of the market to see CAGR between 10-15%.

Blackstone launches cardio-focused biopharma with Novartis

28-Feb-2019 By Maggie Lynch

Blackstone launches Anthos Therapeutics, with the help of Novartis, to develop targeted therapies for cardiovascular disease.

GE continues slim down with $21bn sale of BioPharma business

25-Feb-2019 By Ben Hargreaves

GE announced a change of plans regarding its GE Healthcare business, choosing to sell off the BioPharma business for $21.4bn rather than initiate an IPO.

ATS harnesses electromagnetic technology for cell minimizing unit

21-Feb-2019 By Maggie Lynch

ATS’ SuperTrak Micro minimizes cell sizes through electromagnetic sorting while merging and diverting at full production speed.

Human genome editing committee created after industry calls for standards

20-Feb-2019 By Maggie Lynch

The WHO establishes a multi-disciplinary committee to advise on the ethical and scientific challenges of human genome editing, as the technology’s capability and utilization grows in the industry.

Four-pronged partnership to produce automated systems for CRISPR

20-Feb-2019 By Maggie Lynch

Oxford Genetics and Sphere Fluidics to partner, alongside additional biopharma organizations, to develop automated systems for high-throughput gene editing in mammalian cell lines.

CAR-T for solid tumors drives industry to innovate

08-Feb-2019 By Maggie Lynch

ICT is developing upon CAR-T cell technology to enable T-cells to persist against cancer’s attempt to program death into a patient’s defensive T-cells, which could potentially treat solid tumors.

RNAi research blooms with yeast-based production

07-Feb-2019 By Maggie Lynch

Renaissance BioScience enters a partnership with Mitacs to test its yeast-based, RNAi production platform for biocontrol and biotherapeutics applications.

Fujifilm ‘combining forces’ to create bioprocessing center of excellence

06-Feb-2019 By Maggie Lynch

Fujifilm Diosynth announces the inception of its FDB center of excellence in bioprocessing 2.0 to extend its bioprocessing innovations with a network of researchers.

Janssen collaborates on gene therapies for retinal disorders

05-Feb-2019 By Maggie Lynch

Janssen enters collaboration with MeiraGTx for the development and commercialization of retinal disorder gene therapies.

‘Entire cell therapy sector’ realizes importance of supply chain management

30-Jan-2019 By Maggie Lynch

TrakCel will build a supply chain tracking platform to manage the clinical development of WindMIL’s personalized cellular therapies.

Single cell formulation set-up to ‘efficiently deliver RNA vaccines’

29-Jan-2019 By Maggie Lynch

Dolomite’s high throughput, single cell encapsulation set-up aims to accelerate delivery of RNA vaccines.

Five reasons biologics contract manufacturing will hit $87.6bn by 2027

25-Jan-2019 By Ben Hargreaves

The contract market for bringing biologics through the pipeline to commercialisation is growing at a rapid clip, with a recent report suggesting a high CAGR in the sector.

GE Healthcare and G-CON create platform for advanced therapy production

24-Jan-2019 By Ben Hargreaves

GE Healthcare and G-CON have combined capabilities to offer drug developers ‘readily deployable’ manufacturing platforms for cell therapies and viral vectors.

Alvotech fundraises $300m to bolster biosimilar development

23-Jan-2019 By Maggie Lynch

Alvotech raised $300m through a private bond offering and is set to use the earnings to continue the growth of its biosimilar pipeline.

Sarepta signs plasmid supplier agreement after clinical trial hold

15-Jan-2019 By Maggie Lynch

Sarepta signed a long-term agreement for the supply of plasmid DNA for its gene therapy program and the needs of any future programs.

Catalent to double biomanufacturing capacity with $200m investment

10-Jan-2019 By Ben Hargreaves

Catalent will use the funds to enlarge drug substance manufacturing and drug product fill/finish capacity.

‘An incredible opportunity’: Takeda signs immuno-oncology collaborations

10-Jan-2019 By Maggie Lynch

Takeda entered multiple research collaborations for immuno-oncology and CAR-T therapies, an area of strategic focus for the company.

Fujifilm invests $112m on two fronts with new site and expansion

08-Jan-2019 By Ben Hargreaves

Fujifilm has launched an upgrade to its subsidiaries manufacturing capabilities, by increasing capacity by 50% at an existing facility and building an entirely new site for cell technology.

Biologics company sells shares, registers with SEC

04-Jan-2019 By Maggie Lynch

Harpoon offers to sell shares of its common stock in its proposed IPO after registering a statement with the SEC while developing T-Cell engagers.

MilliporeSigma and genOway enter CRISPR collaboration

19-Dec-2018 By Maggie Lynch

genOway has acquired exclusive rights to MilliporeSigma's genome-editing patents to produce and sell new rodent models.

Biotage acquires Phynexus in $21.5m deal

11-Dec-2018 By Maggie Lynch

Biotage will add PhyNexus’ platform for higher throughput purification at lab-scale.

Tech focus: Making waves with acoustic separation in cell processing

06-Dec-2018 By Ben Hargreaves

FloDesign Sonics is using ‘acoustophoresis’ to address challenges in cell therapy manufacture.

Catalent expands biologics facility, to create 36 new jobs

04-Dec-2018 By Maggie Lynch

Catalent is expanding its US biologics packaging facility, following recent investments and expansions in the Asia-Pacific region.

Q&A

UK cell and gene therapy ecosystem ‘second to none’

26-Nov-2018 By Ben Hargreaves

The UK has a ‘rich and vibrant’ advanced therapeutic manufacturing sector well placed to attract companies post-Brexit, says Keith Thompson, CEO of CGTC.

UK invests to streamline manufacture of next-gen medicine

23-Nov-2018 By Ben Hargreaves

Funding of £7.3m will be provided across three initiatives, with the long-term aim of providing patients with access to cell and gene therapies at a faster rate.

Lonza centers itself in Israel for innovation in biologic manufacturing

20-Nov-2018 By Maggie Lynch

Lonza Pharma & Biotech established itself in Israel, with the opening of a collaborative hub aiming to advance manufacturing technology for cell and gene therapy commercialization.

US FDA warning: Illegally marketed stem cell therapy made in substandard lab

14-Nov-2018 By Flora Southey

California-based StemGenex marketed its SVF drug without an approved biologics license application, according to the agency.

Astellas invests $256m in cell therapy manufacturing buildout

07-Nov-2018 By Ben Hargreaves

The company will construct two facilities in Japan and relocate its regenerative medicine facility in the US.

Gene editing partnership to provide custom cells for drug discovery

06-Nov-2018 By Maggie Lynch

Ncardia and Horizon Discovery have partnered to provide custom, genetically-modified and differentiated human cells for drug discovery and preclinical models.

CAR-T manufacture ‘where mAbs were in the early 1990s’, says bluebird CTMO

05-Nov-2018 By Ben Hargreaves

With cell and gene therapies developing at a rapid pace, it leaves significant questions as to how manufacturing processes are keeping up.

Avid expansion to triple process development capacity, says CEO

25-Oct-2018 By Ben Hargreaves

Avid continues its transition to a fully-fledged CDMO by transforming its process development capabilities with new lab space.

MilliporeSigma adds first non-mammalian cell line to portfolio

24-Oct-2018 By Maggie Lynch

MilliporeSigma collaborates with GlycoBac to provide an Sf-9 insect cell line for vaccine and gene therapy development.

BIA Bioscience Forum

Four major barriers to efficient cell & gene manufacture

22-Oct-2018 By Ben Hargreaves

BIA’s Bioscience Forum brought together four experts on cell and gene manufacture to discuss what difficulties are being faced in the industry and how they are reacting to them.

Berkeley Lights looks to CAR-T manufacture after securing $95m investment

19-Oct-2018 By Ben Hargreaves

This week Berkeley announced it had tied up a financing round and signed a cell line development deal with Selexis.

Lonza expands manufacturing sites for larger ADC payloads

16-Oct-2018 By Maggie Lynch

Lonza Pharma & Biotech will expand two of its manufacturing sites to reach the capabilities necessary to produce compounds bio-conjugates through to commercialization.

Mammalian plant a convenient option for growing Asian client base, says AGC

12-Oct-2018 By Flora Southey

AGC Biologics has announced plans to build a mammalian cell culture facility in Japan, where the company says demand is growing for antibody-based therapies.

Q&A

Plant-based expression system produces higher yields than mammalian alternatives, says CEO

11-Oct-2018 By Flora Southey

Leaf Expression Systems’ technology enables the manufacture of proteins, vaccines and complex biomolecules without using animal-based products, says recently appointed chief executive.

Daiichi-Merck partnership lines up Keytruda combo therapy

09-Oct-2018 By Maggie Lynch

Daiichi Sankyo announced it has entered into a clinical trial collaboration agreement with Merck & Co. to evaluate an investigational lung cancer treatment.

Report: Bioprocessing trends 2018-2023

08-Oct-2018 By Flora Southey

Increased cell and gene therapy production and reduced development timelines are listed among bioprocessing trends predicted over the next five years, says consultant.