Kite says a two-year retrospective analysis of the commercial manufacturing and supply of its CAR T therapy, axicabtagene ciloleucel (Yescarta), shows a high manufacturing success rate and a reliable turnaround time.
TCR2 Therapeutics Inc, a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from cancer, has signed a lease for an 85,000 square foot cell therapy manufacturing facility in Rockville, Maryland: which is...
A couple of new developments to report in relation to Merck, known as MSD outside the US and Canada: the first being the rejection by the US FDA of the company’s application to use its anti-PD-1 therapy, Keytruda, in certain breast cancer patients.
A US court’s recent decision to find in favor of Sanofi and invalidate Amgen's broad antibody patent claims has biotech manufacturers concerned about how to preserve their IP.
US company, KIYATEC, says a new study has shown that its immune-modified ex vivo platform can measure treatment response through direct interaction between a patient's cancer and infiltrating immune cells, and immuno-oncology agents.
Thermo Fisher Scientific has announced a new, first-of-its-kind human plasma-like cell culture medium that more closely resembles the natural cellular environment found in the human body to provide researchers with a realistic view of cell growth.
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.
Precigen claims breakthroughs in CAR T cell therapy manufacturing that will eventually allow cancer centers to enable treatments earlier and at a lower cost.
From new research offering promise for children's cancer to FDA registrations, we track the progress made in the past few weeks in terms of advancing CAR T-cell therapy in a number of markets.
AbbVie and Caribou Biosciences have entered into a collaboration and license agreement for the research and development of chimeric antigen receptor (CAR)-T cell therapeutics.
Previously Rexgenero Ltd, a UK-based company developing cell therapies to treat serious diseases such as cancer and CLTI, the launch of Ixaka Ltd follows the integration of its nanoparticle gene therapy business in France and a shareholder restructuring....
Therapies for cancer, autoimmune diseases, inflammatory diseases and other drug markets are all siloed, despite new research emerging that shows potential connections between them. In order to create more effective therapeutics, we need to pull from research...
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.
Preclinical contract research organization (CRO), Charles River Laboratories International, has announced the acquisition of an antibody discovery company, Distributed Bio, for US$83m in cash.
A new study suggests that CAR T-cells, which are already used to treat certain blood cancers, may also be successful against solid tumors if combined with other immunotherapeutic approaches.
New data shows a move towards commercialization and a 48% increase in GMP cell and gene therapy (CGT) manufacturing space in the UK this year despite the COVID-19 pandemic.
Janssen Pharmaceuticals, Inc. has acquired the rights to Hemera Biosciences’ investigational gene therapy HMR59: which has been designed to help preserve vision in patients with severe age-related macular degeneration (AMD).
Special Edition: The Future of Continuous BioProcessing
Erbi Biosystems recently raised US$3.8m in a round led by Jaguar Biotech; the funds will allow the company to expand its platform of microfluidic bioprocess and bioreactor equipment, which is said to enable ultra-high cell density and continuous processing.
From operational uncertainty and outdated manual processes to new cell lines and a potential shift towards allogeneic cell therapy, CRB’s new report - Horizons: Cell and Gene Therapy - finds the biopharma industry at the critical intersection of obstacle...
The future of treatment for many of the most challenging diseases in the world is said to reside in personalized cell and gene therapy (CGT). These expensive and complex therapies have proven highly effective in multiple cases, but a challenge remains...
Watson-Marlow Limited Ireland has announced plans for a new state-of-the-art cleanroom facility in Cork to support Ireland’s biopharmaceutical manufacturing industry.
Agenus Inc, an immuno-oncology company with a pipeline of agents designed to activate immune response to cancers and infectious diseases, has reported the dosing of the first COVID-19 patient with agenT-797, an allogeneic cell therapy, through its subsidiary,...
Thermo Fisher Scientific Inc has inked a joint venture deal with Innoforce, a Chinese bioinnovation-enabling company, to establish a new pharma services facility in Hangzhou, China, for integrated biologics and steriles drug development and manufacturing....
Novartis has acquired Vedere Bio, giving the company a new platform for AAV-based delivery of gene therapies and an optogenetics program for the treatment and prevention of vision loss and blindness.
A new mathematical modeling study by Ashish Goyal and colleagues, informed by data collected from 25 patients hospitalized with COVID-19 in four different countries, offers some important new insights into the optimal timing of four different antiviral...
Scientists have used gene therapy and a newly developed light-sensing protein to restore sight in mice: with the technology to start clinical trials in the US later this year.
Ori Biotech Ltd (Ori), a London and New Jersey based innovator in the cell and gene therapy (CGT) manufacturing sphere, last week announced the successful close of a US$30m Series A financing round, bringing the company’s total funding to date to US$41m.
Locus Biosciences has signed a contract with BARDA to co-fund development of LBP-EC01, a CRISPR Cas3-enhanced bacteriophage (crPhage) that targets E. coli bacteria causing recurrent urinary tract infections (UTIs).
Fujifilm is boosting its gene therapy offering, taking the first steps to expand its viral vector contract development and manufacturing organization (CDMO) services to Europe, at the site of Fujifilm Diosynth Biotechnologies (FDB) in the North East of...
The UK’s Vaccines Manufacturing & Innovation Centre (VMIC) announces that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved the second of two GMP COVID-19 vaccine manufacturing suites located at Oxford Biomedica's...
German life science company Sartorius will merge Slovenian purification specialist BIA Separations with Sartorius Stedim Biotech, in a deal worth €360m ($423m).
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.
Symbiosis Pharmaceutical Services reported a successful audit outcome by the UK government regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) for its Scottish production site.
Catalent recently announced that it is investing US$130m in an expansion project at its viral vector manufacturing facility located in Harmans, Maryland, with five new manufacturing suites set to respond to a growing customer pipeline and market demand.
Viral vector production capacity has become increasingly constrained in recent years due to increases in the therapies in development, the dosages given and the patient populations targeted. COVID-19 is exacerbating the situation.
Recognizing the industry-wide need to improve adeno-associated virus (AAV) vector manufacturing, Applied Genetic Technologies Corporation (AGTC) has adopted changes intended to increase yield and purity.
Naturally occurring viral vectors of human liver origin may be more effective than vectors grown in cultured lab conditions for liver gene therapy, according to a study published in Science Translational Medicine this month.
BioNTech will acquire Novartis’ GMP certified manufacturing facility in Marburg, Germany: with the site set to become one of the largest mRNA manufacturing plants in Europe.
Gene therapy developer, CombiGene, and CDMO, Cobra Biologics, have signed off on a deal to secure Good Manufacturing Practice (GMP) production of two essential plasmids needed for the manufacture of CombiGene's gene therapy, CG01.