Manufacturing, Cell Therapies

FDA has approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for treating patients with unresectable or metastatic melanoma.

Despite slow growth over recent years, the CAR-T cell therapy space is expected to see considerable advancements in the near future.

Buffers, stabilizers, and cryoprotectants play major roles in cell therapy formulations.

The milestone approval of a gene-edited therapeutic paves the way for gene-editing technologies.

The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.

Pluri has launched PluriCDMO, a new contract development and manufacturing organization business that will offer cell therapy manufacturing services.

AstraZeneca’s acquisition of Gracell includes a clinical-stage autologous cell therapy targeting hematologic malignancies and autoimmune diseases and a proprietary manufacturing platform.

Revolutionary therapies restructure pharmaceutical manufacturing.

There are positive indications for future growth.

Through Syena, its oncology-focused product company, Replay will develop and manufacture T-cell receptor and natural killer cell therapies with the NIH and Miltenyi Biotec.

Tome Bioscience is facilitating the transition in biology from the editing phase to the cut-and-paste phase.

Preparing for variability and flexible processing are necessary for success.

Chris Spivey, editorial director for Pharmaceutical Technology, discusses messenger RNA (mRNA) advances with Guillaume Roelandts, Head of Products and Marketing, Quantoom Biosciences, at the 11th International mRNA Health Conference in Berlin, Germany.

Novartis and Legend Biotech seek to advance certain CAR-T cell therapy candidates targeting Delta-like ligand protein 3.

CDMOs are actively exploring and leveraging both new and existing technologies to streamline the cell-line development process at every step.

A look at using best practice tech transfer methods for CGTs to increase process and analytics robustness while being scalable.

Chris Spivey, editorial director, hosts a wide ranging discussion on the COVID-19 pandemic response, future government communications, and healthcare funding for mRNA with experts Dr. Kate Broderick, Chief Innovation Officer, Maravai LifeSciences and Dr. Tom Madden, President & CEO at Acuitas Therapeutics. Highlights include supply chain modalities, ensuring a fully trained manufacturing workforce, combining delivery with gene editing innovations, epigenetic approaches to modulate gene expression moving toward the clinic. We conclude with the huge potential for RNA expression of monoclonal antibodies and protein replacement applications.

Humberto Vega, PhD, Executive Director, Bristol Myers Squibb, discusses the requirements needed to be successful in global cell therapy as a part of his session, "Successfully Navigating Global Cell Therapy Requirements."

Under an expanded agreement, Cellares will provide proof-of-concept manufacturing for a second CAR-T cell therapy from Bristol Myers Squibb.

The 65,000-square-foot facility is designed with the capacity and capability to help scale the next generation of CGTs for human trials and beyond.

Humberto Vega, PhD, Executive Director, Bristol Myers Squibb, discusses the journey from clinical to commercial cell therapies as a part of his session, "Successfully Navigating Global Cell Therapy Requirements."

The agreement will enable CTMC to strategically scale the recently completed good manufacturing practice facility to drive high-throughput manufacturing utilizing the automated, closed system capabilities of the Fresenius Kabi Lovo and Cue cell processing systems.

The Novo Nordisk Foundation will invest up to DKK 950 million (€127 million, US$136 million) in a new cell therapy manufacturing facility in Lyngby, Denmark.

A novel complement therapeutic CTx001 offers a novel approach to treating geographic atrophy.

Plasmid DNA (pDNA) is a critical raw material for the manufacture of cell and gene therapies. As this market continues to grow, so too does the demand for high-quality pDNA.