Manufacturing, Gene Therapies

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.

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.

Complex hurdles complicate the development of emerging therapies.

Plant-based manufacturing technology gains mainstream edge in biopharmaceutical production.

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

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

CGTs offer hope for the future of treatments, but the costly manufacturing, slow turnaround time, and need for supplies hinder progress.

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.

A rich clinical pipeline of regenerative medicine product candidates bodes well for a robust future.

With this investment into Yapan Bio, Piramal Pharma adds new technologies and capabilities in large molecules, including vaccines and gene therapies, to its global offering.

Enhancement of resin technology can improve the ability of chromatography to purify the growing landscape of increasingly complex biomolecules.

Genezen has opened its new process development and analytical lab for viral vector production.

Pfizer invested $68.5 million in a facility in Durham, NC.

SKAN’s new Cellana isolator is designed for GMP manufacturing of ATMPs.

Guide addresses challenges of applying GMPs to autologous cell therapy manufacturing.

Timing is everything, and it might be ideal for acceleration of real-time monitoring solutions.

Scientific innovation and regulatory reformations are helping to drive the global biopharma market forward, but a balance between cost and value still needs to be accepted for widespread adoption.

Part 2—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius provide insight and examples about solving critical challenges in both analytics and process development for emerging therapies.

Part 1—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius discuss key issues affecting the development of emerging biotherapies.

The need for improved analytics grows.