NEW YORK - MannKind (NASDAQ: MNKD) will be strutting the aisles of Interphex this week, chest out, a smile on its corporate face. The company is a double winner in the 2010 Facility of the Year competition for its Danbury, CT, commercial manufacturing facility, custom-built for the production of its proprietary insulin therapy Afrezza. The annual contest is run by ISPE, Pharmaceutical Processing magazine and Interphex.
CTO Juergen Martens (pictured), a 20-year life sciences vet and five-year MannKind exec, will be at the show on Wednesday, at the FOYA reception. He will speak about MannKind's double-win, which includes the top spot in both the FOYA process innovation and equipment innovation categories. We spoke with him by phone before the event about the $163 million, combination renovation/new-construction facility that covers 23,400 square meters.
Martens was responsible for reviewing product technology to understand quality and design parameters and the issues affecting tech transfer to the facility during scale-up. "Everyone was excited about the product," he recalls. "But the only thing that really matters is whether the processes are clearly understood and can be made to run repeatedly and reliably."
The FOYA process innovation award recognizes the company's engineering of a manufacturing process line that has two parts: One for controlled crystallization, and the other for filling.
The controlled-crystallization process, used for bulk formulation, required development of a technology involving self-assembling organic modules. "No technology was available that we could make use of," Martens says. "We needed to look at equipment used for similar purposes and then adapt it." Likewise, the fill/finish operation required the adaptation of existing technology to suit the production need, which involves the insertion of cartridges into a delivery system.
Martens cites the team's development of a cryopelletizer adapted for solid-dosage pharmaceuticals as one of the key achievements, and the unit earned MannKind the FOYA equipment innovation award. The company worked with Cryogenic Equipment Services to modify a food-industry cryopelletizer so it creates uniform pellets from slurry, allowing water to be removed quickly during bulk lyophilization.
Martens figures that, in the "all-hands-on-deck" latter stages involving CMC development, some 250 MannKind employees, plus contractors and service providers, with expertise spanning all facets of drug development and operations, were all working together.
- take a look at Mannkind's release