Manufacturing, Cell Therapies

Experiments conducted by the downstream technology team at Spark Therapeutics involving metal ion-containing additives showed improved capsid clearance in AAV production.

Under a partnership, ProPharm and PBL have launched the Cell Factory Box, an enclosed and fully automated cell factory manufacturing device.

A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.

The new draft guidance from FDA provides recommendations for sponsor companies on cell safety testing of human-origin allogeneic cells.

The collaboration aims to scale-up TreeFrog’s process to produce and amplify cells for Vertex’s type 1 diabetes cell therapies.

Under the agreement, Bristol Myers Squibb will have access to Cellares’ fully automated cell therapy manufacturing platform, Cell Shuttle, to manufacture select CAR-T cell therapies.

Memel Biotech aims to offer a range of services from discovery through to formulation for preclinical through to late-stage clinical and commercial production of advanced therapies.

Univercells and Altamira Therapeutics are collaborating on nanoparticle-delivered mRNA vaccines, while Andelyn Biosciences and Grace Science are partnering on novel therapies for NGLY1 deficiency.

Cellares CEO Fabian Gerlinghaus explores advancements in counterflow centrifugal elutriation and electroporation, teasing exciting developments in product testing.

Understanding how to apply phase-appropriate GMPs is crucial for achieving successful regulatory approval.

Under a new agreement, Chime Biologics will manufacture Domain Therapeutics’ antibody cancer immunotherapy candidate, DT-7012.

Proprietary cell lines offer opportunities for achieving high AAV titers.

CSL will share access to Cytegrity, its proprietary stable production system for lentiviral vector production, with Genezen.

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.