The facility is expected to come online in early 2016 and will support Juno's planned JCAR015 multicenter clinical trial, additional clinical programs in Juno's pipeline, and the company's first commercial products. A company spokesman told us the facility will be 67,799 square feet.
But the company doesn’t know how successful its manufacturing operations will be, noting in an SEC filing: “we have no experience as a company in developing a manufacturing facility and may never be successful in developing our own manufacturing facility or capability.”
Perhaps due to this lack of experience, Juno says it will continue to work with its existing CMO (contract manufacturing organization) partners to augment its manufacturing capabilities, and to enhance flexibility, provide redundancy, and increase capacity.
Possible Difficulties
The manufacture of Juno’s biologics involves complex processes, including harvesting T cells from patients, genetically modifying the T cells ex vivo, multiplying the T cells to obtain the desired dose, and infusing the T cells back into a patient’s body.
“Our manufacturing process will be susceptible to product loss or failure due to logistical issues associated with the collection of white blood cells, or starting material, from the patient, shipping such material to the manufacturing site, shipping the final product back to the patient, and infusing the patient with the product, manufacturing issues associated with the differences in patient starting materials, interruptions in the manufacturing process, contamination, equipment or reagent failure, improper installation or operation of equipment, vendor or operator error, inconsistency in cell growth, and variability in product characteristics,” Juno says, noting that even minor deviations from normal manufacturing processes could result in reduced production yields, product defects, and other supply disruptions.
“If for any reason we lose a patient’s starting material or later-developed product at any point in the process, the manufacturing process for that patient will need to be restarted and the resulting delay may adversely affect that patient’s outcome,” the company warns.
And Juno also warns that the reagents that make up its clinical products, which are manufactured by smaller companies, may be difficult to come by in the future.
“Manufacturing our product candidates will require many reagents, which are substances used in our manufacturing processes to bring about chemical or biological reactions, and other specialty materials and equipment, some of which are manufactured or supplied by small companies with limited resources and experience to support commercial biologics production,” Juno says. “We currently depend on a limited number of vendors for certain materials and equipment used in the manufacture of our product candidates. Some of these suppliers may not have the capacity to support commercial products manufactured under cGMP by biopharmaceutical firms or may otherwise be ill-equipped to support our needs. We also do not have supply contracts with many of these suppliers and may not be able to obtain supply contracts with them on acceptable terms or at all.”
Despite the potential difficulties, Hans Bishop, CEO and president of Juno, remains optimistic. He said in a statement: "The manufacturing expertise we are developing is key to our long term success, increasing our ability to run multiple clinical trials and commercialize our pipeline, and as a platform to introduce the various innovations we are investing in to optimize patient outcomes."