- On Wednesday, bluebird bio Inc. showcased its efforts in manufacturing, announcing a major new investment in a 125,000-sq. ft. manufacturing facility in Durham, North Carolina.
- Once the facility is complete and validated, it will produce lentiviral vectors for the company's experimental gene therapies, including its beta-thalessemia gene therapy LentiGlobin.
- As well as building out its own capabilities, bluebird said it has entered into multi-year agreements with three manufacturing partners in the U.S. and Europe: Brammer Bio in Cambridge, MA; Novasep in Gosselies, Belgium; and MilliporeSigma, the life science business of Merck KGaA in Carlsbad, CA. The company already has agreements in place with Lonza in Houston, TX, and apceth Biopharma in Munich, Germany.
Manufacturing the viral vectors that serve as the delivery vehicle for gene therapies poses a overlooked hurdle to the gene therapy field, as a report earlier this week in The New York Times highlighted.
Producing the inactive viruses can be costly and time-consuming, the article noted, presenting a challenge to companies entering the pace.
Bluebird's manufacturing facility, as well as the new production agreements, will help the biotech ensure it can meet the demands of its clinical development plans — as well as commercial production needs if any drug candidates win approval.
"Our goal is to bring multiple therapies to market over the next four years that can transform the lives of people suffering from severe genetic diseases and cancer," said Derek Adams, bluebird's chief manufacturing and technology officer, in a Nov. 29 statement.
"By simultaneously establishing multiple lentiviral vector manufacturing partnerships and pursuing in-house manufacturing, bluebird is uniquely positioned to adeptly, robustly, and reliably provide our current gene and cell therapy products in development, as well as future pipeline therapies to patients in need," he added.
Bluebird recently changed its manufacturing process for its LentiGlobin gene therapy, incorporating two additives into the process that are meant to increase the number of viral vectors in each dose and thus improving the percentage of transduced cells.
That isn't to say there aren't other obstacles. Gene therapies like LentiGlobin or bluebird's Lenti-D therapy for cerebral adrenoleukodystrophy require a patient's own isolated stem cells — adding complexity to producing such treatments on a large scale.
The facility will also support production of lentiviral vectors for the company's CAR-T candidates bb2121 and bb21217 for the treatment of multiple myeloma.