Manufacturing, Gene Therapies

Significant improvements have been developed to tackle the challenges in viral vector manufacturing at each stage.

CBER maps modernization plan to handle surge in research and applications.

Production of viral vectors requires a holistic view of the product, including its manufacturing process and its ultimate end use.

Whether biologic manufacturers decide to outsource or develop products internally, the quality of a CDMO partnership is critical to success, especially for cell and gene therapy products.

Biopharma focuses on streamlining biomanufacturing and supply chain issues to drive uptake of cell and gene therapies.

Charles River Laboratories and Cure AP-4 will collaborate on gene therapy manufacturing for AP-4 hereditary spastic paraplegia.

Forecyte Bio and Cytiva will team up to accelerate the development and manufacturing of cell and gene therapies.

Pfizer and Touchlight have signed a patent license agreement for Pfizer to use Touchlight’s doggybone DNA (dbDNA) in the manufacture of mRNA vaccines, therapeutics, and gene therapies.

In this exclusive Drug Digest video, experts from Roche and MilliporeSigma divulge factors that could influence an organization to pursue specific biomolecules for development.

REGENXBIO has opened a new in-house facility at its headquarters in Rockville, Md., that will be used to manufacture AAV gene therapies at commercial scale.

Astellas Pharma has opened its new gene therapy manufacturing facility in Sanford, NC, which will support clinical- and commercial-scale manufacturing of AAV vectors for gene therapies.

Eli Lilly and Company plans to build two new manufacturing sites at Indiana's LEAP Lebanon Innovation and Research District in Boone County.

Precompetitive consortiums seek solutions to industry-wide challenges.

AGC Biologics is investing in viral vector suspension technology at its new Longmont, Colo., facility.

Through a collaboration, Avantor and Cytovance Biologics will accelerate plasmid optimization and sourcing services for viral vectors and mRNA-based vaccines and therapeutics.

In this episode of Drug Digest, Pharmaceutical Technology editors, Felicity Thomas and Feliza Mirasol, examine the topic of emerging therapies in more detail, covering subjects such as the challenges of scale, the potential benefits of drug delivery innovation, importance of early analytical studies, the evolution of the regulatory landscape, and differences between regional regulatory requirements.

In this episode of the Drug Solutions Podcast, Feliza Mirasol, Pharmaceutical Technology’s science editor, discusses technologies enabling biologics and emerging therapies manufacturing and development with Barry Holtz, PhD, chief scientific officer of Phylloceuticals, and Professor Yaakov Nahmias, founder and chief scientific officer, Tissue Dynamics and founder and president, Future Meat Technologies.

Researchers demonstrated a new cell lysis method using a novel solution to improve viral vector production.

In this episode of the Drug Solutions Podcast, Meg Rivers, senior editor, interviews Joy Aho, senior product manager at Be The Match BioTherapies, about sourcing autologous and allogeneic cell therapies.

VectorBuilder will expand with the construction of new $500 million Gene Delivery Research and Manufacturing Campus in Guangzhou, China.

The booming cell therapy market has created a need for capacity that outsourcing partners are ready to fill.

UCB has announced it will build a new innovative gene therapy facility in Belgium.

Eli Lilly and Company are investing $700 million into a Boston-based facility for the newly announced Institute for Genetic Medicine.

Thermo Fisher Scientific's solution for cell and gene therapies involves a combination of cold chain logistics, serialization compliance, and distribution

The acquisition will include Rewrite’s DNA writing platform, expanding Intellia’s genome editing tools.