Lonza and bluebird bio, Establish Long-term Commercial Manufacturing Agreement
OREANDA-NEWS. Lonza Houston, Inc., a global leader in viral gene and cell therapy manufacturing, and bluebird bio, Inc., a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer, have entered into a strategic manufacturing agreement providing for the future commercial production of bluebird bio’s Lenti-D™ and LentiGlobin™ drug products.
This agreement follows a successful multi-year clinical manufacturing relationship and provides bluebird bio with a path to commercial supply including dedicated production suites within Lonza’s state-of-the-art facility. This facility is currently under construction, for the clinical and commercial supply of viral vectors and virally-modified cell therapy products.
Under this multi-year agreement, Lonza will complete the suite design, construction and validation along with process validation prior to anticipated commercial launch.
“This new strategic relationship with bluebird bio, is an example of Lonza’s ability to be a long-term commercial partner to the cell & viral therapy industry,” said Marc Funk, COO, Lonza’s Pharma & Biotech segment. “Our global facilities, regulatory track record and security of supply offer customers like bluebird bio a reliable strategic manufacturing partner for the lifetime of their therapeutic drugs.”
“As we advance our gene therapy programs through clinical trials, we are deliberately building key infrastructure and relationships in preparation for commercial launch,” said Nick Leschly, chief bluebird. “Our partnership with Lonza is one notable example of our progress on the manufacturing front, and we are pleased to benefit from their expertise and experience as we continue working to bring transformative therapies to patients in need.”
About Lonza
Lonza is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. We harness science and technology to create products that support safer and healthier living and that enhance the overall quality of life.
Not only are we a custom manufacturer and developer, Lonza also offers services and products ranging from active pharmaceutical ingredients and stem-cell therapies to drinking water sanitizers, from the vitamin B3 compounds and organic personal care ingredients to agricultural products, and from industrial preservatives to microbial control solutions that combat dangerous viruses, bacteria and other pathogens.
Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 40 major manufacturing and R&D facilities and approximately 9,800 full-time employees worldwide. The company generated sales of about CHF 3.8 billion in 2015 and is organized into two market-focused segments: Pharma&Biotech and Specialty Ingredients.
About bluebird bio, Inc.
With its lentiviral-based gene therapies, T cell immunotherapy expertise and gene editing capabilities, bluebird bio has built an integrated product platform with broad potential application to severe genetic diseases and cancer. bluebird bio’s gene therapy clinical programs include its Lenti-D™ product candidate, currently in a Phase 2/3 study, called the Starbeam Study, for the treatment of cerebral adrenoleukodystrophy, and its LentiGlobin™ BB305 product candidate, currently in three clinical studies for the treatment of transfusion-dependent ?-thalassemia, and severe sickle cell disease. bluebird bio’s oncology pipeline is built upon the company’s leadership in lentiviral gene delivery and T cell engineering, with a focus on developing novel T cell-based immunotherapies, including chimeric antigen receptor (CAR T) and T cell receptor (TCR) therapies. bluebird bio’s lead oncology program, bb2121, is an anti-BCMA CAR T program partnered with Celgene. bb2121 is currently being studied in a Phase 1 trial for the treatment of relapsed/refractory multiple myeloma. bluebird bio also has discovery research programs utilizing megaTALs/homing endonuclease gene editing technologies with the potential for use across the company’s pipeline.
bluebird bio has operations in Cambridge, Massachusetts, Seattle, Washington, and Paris, France.
LentiGlobin and Lenti-D are trademarks of bluebird bio, Inc.
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