Manufacturing, Cell Therapies

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

Achieving effective manufacturing processes and sufficient capacity remains a top priority across a diversified biologic drug pipeline.

While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar.

The acquisition expands Charles River’s scientific capabilities in cell therapy development.

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.

Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting materials, and they must ensure a steady supply.

Ensuring that viral vectors are free of viral contaminants requires a focus on prevention and control.

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.

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.

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

Manufacturing differences between traditional mAb therapies and newer biotherapeutics dictate whether processes should be scaled up, scaled out, or use an alternate approach for commercial production.

The use of scale-down models allows for the theoretical optimization of processes and for troubleshooting problems during the developmental stage.

Accelerated timelines and small batch volumes of cell and gene therapies pose unique challenges for product-release testing.

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.

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

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.

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.

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

The new program, Cornerstone, integrates process development expertise and novel technology to remove development bottlenecks in the manufacture of gene therapy medicinal products.

The venture will focus on single-use and modular systems designed to develop novel biotherapeutics.

TrakCel and McKesson have formed a collaboration that is aimed at accelerating commercialization of cell and gene therapies by leveraging services to enable a more efficient development pathway.

The companies plan to create a new curriculum focusing on single-use applications training, cell therapy technology, process efficiency strategies, process development methodologies, and chromatography proficiency.

Innovation in manufacturing technologies must occur to ensure the availability of gene and cell therapies.