Manufacturing, Cell Therapies

The new facility, located at the company’s headquarters in Pittsburgh, PA, is expected to meet all clinical and commercial development needs of the company’s lead gene therapy program.

While allogeneic therapies can use existing regulatory and quality frameworks, autologous treatments will require pharma’s adoption of true just-in-time and right-first-time concepts, says consultant James Blackwell.

Mustang intends to combine an oncolytic virus with an interleukin-13 Rα2-(IL13Rα2)-specific chimeric antigen receptor to potentially enhance efficacy in treating glioblastoma multiforme.

The company will invest an additional $60 million to expand its manufacturing facility in Durham County, NC.

The partnership will expand Lonza’s offering of hematopoietic cell lines.

The acquisition will boost Hitachi Chemical’s presence in the European regenerative medicines market.

Janssen and MeiraGTx will collaborate on the development and commercialization of gene therapies for treating inherited retinal diseases.

TC BioPharm (TCB), developer of CAR-T immuno-oncology products, has completed its first allogenic Gamma Delta T (GDT) cell banks.

G-CON will provide a complete cleanroom infrastructure for GE Healthcare’s cell therapy and viral vector production platforms that will simplify early-stage manufacturing efforts.

Cell and gene therapy platform company, Locate Bio, has announced that it is set to receive key patents for its IntraStem technology covering the United States and Europe

Agenus will leverage Selexis’ SUREtechnology Platform to progress Agenus’ portfolio of next-generation antibody programs.

The new reagents are designed to support clinical-phase and commercialization stages of cell and gene therapy production and to enhance DNA transfection.

A new facility in California will expand Orchard Therapeutic’s capacity to develop and deliver lentiviral vector and gene-corrected hematopoetic stem cells.

Cobra, Pall, and Cell and Gene Therapy Catapult are collaborating to develop continuous manufacturing for gene therapy production.

The new center will integrate biologics drug discovery, development, clinical manufacturing, and commercial manufacturing.

The new collaborative center aims to serve as a hub for innovations in drug development and manufacturing.

Improving the manufacturing of gene therapy vectors will be crucial to making advanced treatments accessible to more patients who need them, agreed panelists at the 2018 Galien Forum.

Experts believe that the contract development and manufacturing organization market will reach $17.38 billion by 2022, with disruptive business models using Industrial Internet of Things (IIot) and single-use technologies proving more profitable and efficient in the long term.

The new program will provide cell and gene therapy companies a more efficient way to ensure quality compliance across collection center networks and to minimize quality system audit burden on these centers.

The expanded Frederick, MD, site will help meet global demand for diagnostic instruments and cell and gene therapies for clinical trials.

New data highlights ability of the SQZ cell therapy platform to preserve cellular functions.

The acquisition will allow Lonza to further develop technology for scalable autologous cell-therapy manufacturing.

The companies will develop and commercialize ARO-HBV, a Phase I/II subcutaneous, ribonucleic acid interference therapy candidate being investigated for the treatment of chronic hepatitis B viral infection.

The companies signed a three-year clinical manufacturing agreement to manufacture GlaxoSmithKline’s specific peptide enhanced affinity receptor T-cell receptor therapy for United States, Canadian, and European clinical trials.

GE Healthcare, Cobra Biologics, and the Centre for Process Innovation (CPI) have entered into a collaboration to advance manufacturing of adeno-associated virus vectors for gene therapy.

FDA awarded nearly $3 million in grants for continuous manufacturing and other advanced manufacturing technologies as part of the agency’s efforts to ensure a robust and reliable supply of biological products.

The CHF 400-million (US$416-million) investment in Lonza's biopark in Visp, Switzerland, will expand Ibex Solutions with two new offerings, drug substance development and drug substance and drug product manufacturing.

Bio-Rad introduces CHT Ceramic Hydroxyapatite XT media and Nuvia HP-Q resin resin for process protein purification.

The combined companies will provide research- and clinical-grade human immune cells, blood products, and related services.

Avalon and Weill will co-develop bio-production and standardization procedures for CAR-T therapy.