- MilliporeSigma will manufacture viral vectors for bluebird bio Inc.'s pipeline candidates through a new multi-year commercial supply agreement.
- Neither company disclosed much about the agreement, other than it focuses on producing lentiviral vectors for bluebird's rare disease gene therapies. The biotech has entered a couple manufacturing deals in the past for its investigational drugs Lenti-D and LentiGlobin, though they were for relatively small amounts of money.
- The new contract comes about a month and a half after bluebird announced that manufacturing changes to the LentiGlobin production process initiated last year have lead to noteworthy increases in the treatment's potency. Three trials testing the drug in patients with sickle cell disease or beta thalassemia are currently enrolling.
With bluebird's treatments progressing through the clinic, the company faces the daunting task of not only providing investigators with enough material to conduct their advanced trials, but showing it can create a commercial supply as well.
The Massachusetts-based drugmaker has made a couple big strides to that end over the last year or so. In addition to the LentiGlobin manufacturing changes, bluebird in November acquired a 125,000-square foot manufacturing facility in Durham, North Carolina that will make lentiviral vectors its gene and cell therapies once validated.
Within that announcement, bluebird also said it had inked multi-year partnerships in the U.S. and Europe with Brammer Bio, Novasep and and MilliporeSigma.
In spite of those developments, bluebird continues to rely completely on third party players to do its manufacturing.
And even once it brings some capabilities in-house, it will still have to overcome the innate difficulties associated with gene therapy production.
"Gene therapy involves the delivery of genetic material into patient cells to produce a therapeutic effect such as correction of a mutated gene or retargeting of an immune cell to fight cancer. To create personalized therapy products, genes are delivered into immune cells using viral vectors like the ones manufactured by MilliporeSigma," the contract manufacturing organization said in a Wednesday statement.
bluebird spent $180.5 million on R&D during the first nine months of 2017, up more than 22% from the same period a year prior. Manufacturing expenses grew by $18 million between the two periods.