Two Cell and Gene Therapies Manufactured at Lonza Houston Reach FDA Approval – Contract Pharma

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Approvals of Zynteglo and Skysona mean that Lonzas Houston site now supports three commercial CGT products.

10.11.22

Lonza Houston is dedicated to contract cell and gene therapy development and manufacturing. The facility successfully passed Food and Drug Administration (FDA) pre-Licensing inspections for the viral vector manufacturing or for the cell therapy manufacturing of three commercial cell and gene therapy products that were subsequently approved by the FDA for commercial use in 2021 and 2022.

Lonzas Cell & Gene Technologies (CGT) business, the contract development and manufacturing business unit of its Cell & Gene division, has developed an NPI process to support customers on their journey from early-stage development to commercialization. It provides a roadmap and a systematic approach to development and manufacturing, ensuring necessary quality standards are met for tech transfers, cGMP manufacturing and pre-approval inspection readiness. This NPI process has been designed to support more CGT customers in reaching commercialization with their new and innovative products.

"The two new approvals represent an important milestone for bluebird bio and the patients who can now benefit from these therapies, said Alberto Santagostino, senior, head of cell and gene technologies. The successful approvals reflect our colleagues dedication to supporting our customers in bringing these cell and gene therapies to market. Opened less than five years ago, our Houston site is now manufacturing three commercial cell and gene therapies. We look forward to supporting more customers on their path to commercialization as we continue on our journey towards wider cell and gene therapy adoption."

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Two Cell and Gene Therapies Manufactured at Lonza Houston Reach FDA Approval - Contract Pharma