Manufacturing, Gene Therapies

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.

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

Technology and capacity investments create opportunities in the cell and gene therapy arena for CDMOs and biopharma alike.

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

Contract partners must help innovator biotechs consider manufacturability as early as possible in development. This requires focusing on technical and operational performance, as well as cost.

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

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

The commercialization of cell therapies is still at its infancy, but industry is facing an exciting period of development as the sector is expected to grow exponentially.

The trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling early on in the therapeutics’ development.

The production of viral vectors for use in gene therapy benefits from being able to use similar cell-culture processes as mAbs, but it faces limitations under current cell-culture technologies.

Developers need to transcend the limits of existing separation technologies, to maximize vector recovery while preserving therapeutic potency.

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 agency has published seven guidance documents directed at the development and manufacture of 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.

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 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.

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

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.

With the gene-editing technology, Evotec will have the ability to accelerate research and enable the testing and development of new drugs.

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 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.