Manufacturing, Cell Therapies

Contract partners must help innovators, especially smaller and virtual companies, consider manufacturability as early as possible in development. This requires focusing on technical and operational performance, as well as cost.

As cell and gene therapies become more prominent, industry is seeking the expertise and capabilities of outsourcing partners to ensure success.

The need for manufacturing speed inspires contract manufacturers to explore advanced processing technologies.

The new facility, to be operated under the newly formed CDMO, The Center for Breakthrough Medicines, will be located in King of Prussia, PA, and will increase manufacturing capacity for cell and gene therapies.

The new course is directed at analyzing the skills gap in the manufacture of cell and gene therapies as they progress toward manufacturing at scale.

The new company will work to provide the manufacturing technologies and processes needed to develop and commercialize new cell and gene therapies through individual company products and expertise.

The agreement centers around the development of new stem-cell derived allogeneic T-cell therapies for the treatment of cancer.

GE Healthcare Life Sciences’ new facility for cell and gene processing supplies will be open in 2022.

The next-generation gene editing system can be applied to the development of novel cell and gene therapies.

ProBioGen and Lava Therapeutics have closed the cell line development and manufacturing agreement for Lava’s novel bispecific antibody lead candidate.

The new software lets users choose the volume and cell concentration from initial cell preparation through transduction to final resuspension, without compromising cell viability and virus stability.

The new 50,000-square-foot facility will create 200 new jobs and accelerate commercialization of gene and cell therapies.

Aiming to break the bottlenecks that are slowing commercialization of innovative therapies, a new $50-million center in Boston will develop both cell and viral vector products within a single facility.

Biopharma company, Zelluna Immunotherapy, and clinical stage biotech, Glycostem Therapeutics, have entered into a partnership focused on the development and manufacture of allogeneic T-cell receptor guided Natural Killer cell therapies for the treatment of cancer.

Lonza and Cryoport have partnered up to strengthen Lonza’s ‘vein-to-vein’ delivery network by removing supply chain hurdles faced by developers of personalized therapeutics.

A number of experts will be examining investment opportunities within the evolving cell and gene therapy sector, in a panel discussion on Wednesday morning (Nov. 6, 2019) during CPhI Worldwide in Frankfurt, Germany.

Published on Oct. 29, 2019, the study focuses on the multidrug-resistant bacterium Pseudomonas aeruginosa (P. aeruginosa) and how it can be used to develop new and sustainable antibiotic treatments.

The partnership will center on the development and commercialization of DCR-HBVS, Dicerna’s investigational therapy in Phase I clinical development, using its proprietary RNAi platform technology.

The project will seek to deliver treatments for the underlying cause of cystic fibrosis through submitted proposals from potential collaborators.

Principal scientist and R&D project manager at Rousselot, Jos Olijve, will discuss the details of the study at the “Influence of Endotoxin on Cellular Activity” conference on day two of CPhI Worldwide from 3:20 pm to 3:50 pm in the Portalhaus, Transparenz 1 room.

The goal of the investment is for the cures to be made available across the globe, including in sub-Saharan Africa’s low-resource communities.

The therapy received positive results in a randomized, double-blind, placebo-controlled clinical trial in 34 adults with proven celiac disease.

Under the agreement, gene and cell therapy companies can go directly to Aldevron for NTC’s technology without acquiring a license from NTC.

The company will produce the anti-HER3 antibody drug HMBD-001for use within a clinical partnership between Cancer Research UK and Hummingbird Bioscience to test the agent in a Phase I trial.

The long-term agreement gives CombiGene the authority to manufacture and commercialize the drug if it is approved after clinical studies.

MilliporeSigma will now be the first company to make acoustic technology available for cell therapy manufacturing.

Manufacturing of the cell line will take place at Lonza’s GMP facility in Geleen, Netherlands.

The new incubators are set to be operational starting in 2021.

Researchers used advanced animal model lab tests to determine the new vector is 10 times more efficient at incorporating corrective genes into bone marrow stem cells than traditional vectors.

Automated, electronic systems for raw materials tracking improve efficiency and prevent mistakes in biopharma manufacturing.