Innovation and Influence
Flexibility is a critical attribute for any successful contract development and manufacturing organization (CDMO).
It can manifest itself in the ability to manufacture a wide variety of medicines or to rapidly accommodate new client requests. Cook Pharmica’s recently completed Flexible Filling Line (FFL) project enables the company to achieve all this, along with the ability to manufacture vials, syringes, and cartridges from a single filling line.
Seeing strong market acceptance of its existing vial and syringe product lines, and conscious of a shift in the industry to extend the ready-touse platform and utilize new capabilities for filling flexibility, Cook began planning to combine activities associated with what had traditionally been three filling lines into one line under barrier
isolation, in one filling suite.
“With every filled unit representing a patient, we are excited about this capability and capacity to help our clients reach millions more patients,” says Ryan Hawkins, Cook Pharmica’s Vice President and Chief Operating Officer. The concept for Cook Pharmica’s flexible filling line began in 2010. “Over the next five years,” says Hawkins, “things changed in the supply of ready-to-use vials and cartridges, as well as with robotic technology. The changes helped create more possibilities vs challenges associated with processing multiple formats on a single line.”
Cook pursued the development of its concept with two trusted partners, OPTIMA Pharma, the worldwide leader in packaging technologies, including biopharmaceutical filling and packaging, and Nuova Ompi, a global producer of primary glass packaging for the pharmaceutical industry. By combining its product development and manufacturing knowledge with the expertise of a machine builder and a component supplier, Cook created a strong partnership to expand its current capability.
“This partnership was about working together, with a common goal of making a version of flexible filling that would benefit each company and possibly, the industry,” says Hawkins.
Within 12 months of its offcial kickoff meeting in October 2014, Cook’s FFL project staff began factory acceptance testing for the flexible filling line, including the lyophilizer, isolator, and fill line. Cook had available cleanroom space adjacent to its existing filling operations, and to mitigate any disruptions to the site, Hawkins’s team coordinated
with suppliers to have the equipment installed during the plant’s annual shutdown period in December 2015.
“We built this line to be a clinical workhorse, but we also intended it to be commercially capable. We are already doing engineering batches for clients, and we have a number of projects lined up, including the process performance qualification protocol, which is the last stage before commercialization.”
OPTIMA Pharma’s flexible filler is a first-of-its kind solution, capable of filling syringes (up to 5 ml), vials (up to 30 ml) and cartridges (up to 3 ml). The FFL handles all components in a nested format, as well as vials in tray format, a newly available solution from Nuova Ompi. The line offers further flexibility by dosing via peristaltic pumps and
a single-use disposable (SUD) product path or via time-pressure dosing steam-in-place capability.
Automated in-process check weighing and other advanced features ensure accurate dosing and minimal rejects. A 72-sq.-ft. freeze dryer coupled to the line enables manufacture of lyophilized products. The vial capper on the line serves both the new flexible filler and capping product from the adjacent commercial vial line.
The FFL uses barrier isolation technology to provide the highest level of aseptic processing. This includes new catalytic aeration technology that enables short bio-decontamination cycle times, which levels changeover times compared to lines that do not have automated decontamination. No-touch transfers and handling are facilitated through automation of component tub/ tray de-bagging and de-lidding. In addition, robotic denesting/detraying, as well as automated lyophilizer loading and unloading, ensure simple and repeatable transitions and eliminate built-in operator involvement.
STRATEGIC AND INNOVATIVE
For Cook, the new FFL is a strategic enabler that allows the company to expand its manufacturing capabilities and support increased volumes of specialized products within its cGMP offering. The ability to process multiple configurations and formats results in a more cost-eective method of delivering value to customers and end users.
“With the addition of this line, we can now do capping on the FFL for anything that is liquid or lyophilized on our current vial line. It provides us flexibility in terms of format, capacity, and scheduling,” says Hawkins.
In reflecting on the project, Hawkins proudly notes its innovative nature. “It is not always easy to innovate in biopharma,” he says. “I would like to think our new platform could be a leading standard or part of a broader shift in industry. As a CDMO, we may not have our own products, yet that doesn’t mean we can’t innovate or influence industry.”