Manufacturing, Gene Therapies

The new patented process results in uniform, scalable production and the ability to deliver cell cargo similar to natural exosomes/extracellular vesicles.

Thermo Fisher is focused on investing to expand three specific areas of demand: biologics, cell and gene therapy, and drug product development and commercial capabilities.

In January 2020, the agency finalized six clinical development and manufacturing guidance documents and drafted new guidance on what would qualify new gene therapies as orphan drugs.

Tackling process development early on can better optimize manufacturing processes for emerging therapies.

The growing interest in developing cell and gene therapies has prompted industry investment to grow manufacturing capacity.

The last year has seen intense investment activity into raising cell and gene therapy manufacturing capacity.

The 135,000 square foot facility will be constructed over 18 months and is expected to be operational in 2021.

New funding brings competitors, and a leading healthcare products distributor, into the standardization effort.

The new facility includes six classified environment rooms with space to expand.

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.

Vein-to-vein programs are focusing on data access and traceability.

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.

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

The therapy is currently approved in the EU as a gene therapy for the treatment of patients 12 years and older with transfusion-dependent β-thalassemia.

The deal was approved by the Federal Trade Commission following a 10-month investigation.

The acquisition aids in the expansion of the Astellas Focus Area approach, which involves the creation of medicines for diseases with high unmet medical needs by identifying combinations of biology, therapeutic modality and technology based on emerging science.

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.

Fujifilm Diosynth Biotechnologies will add a new building, including gene therapy laboratories, to its facility in College Station, TX.

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.

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

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

The collaboration focuses on baculovirus/Sf9 expression system for Prevail's pipeline of novel AAV9-based gene therapy programs neurodegenerative diseases.

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

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.