Manufacturing, Cell Therapies

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.

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.

Bassem Gayed, PhD, Senior Technical Director of CAR-T Process Engineering, Manufacturing Science & Technology at Bristol Myers Squibb, discusses the connection of process validation and CAR-T processes.

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.

Part of the session "Transforming Medicine: Unleashing the Potential of Cell and Gene Therapies," Sadelain discusses CAR-T cells for immunotherapy and the future of cell/gene therapies.

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.

Scientists are leveraging ddPCR technology to get an accurate read on viral titer and vector copy number.

Cold chain stakeholders continue to innovate with new technology development, the use of advanced modeling and analytics capabilities, and the pursuit of strategic partnerships.

The companies are collaborating to apply ShapeTX’s AAVid capsid discovery platform and transgene engineering technology in addition to Otsuka’s expertise in genetic payload design and ophthalmology to develop novel treatment options for eye diseases.

Despite the successes that have already been achieved with emerging therapy development and manufacturing, companies are still facing numerous challenges.

The agreement states that Orbit will implement its bead-based peptide display engine to discover peptide leads specific to targets related to specific tumors.

Both companies have a focus to developing and commercializing treatments for rare diseases with a strong focus on patients and supporting communities with little to no existing therapeutic options.

Bristol Myers Squibb has joined Cellares’ Technology Adoption Partnership program just as Cellares launches operations as an integrated development and manufacturing organization.

In this episode of Drug Digest, industry experts discuss aseptic processing and manufacturing, including what the future holds in this area and the barriers involved with automated aseptic processing practices.

The agreement focuses on the research of a targeted allogeneic gamma delta chimeric antigen receptor (CAR) T-cell therapy, owned by Regeneron, designed to enhance proliferation and potency against solid tumors, according to the press release.