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-to-use 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 Presi-
dent and Chief Operating Officer.
The concept for Cook Pharmica’s flexible fill-
ing 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.”
“This partnership was about working togeth-
er, with a common goal of making a version of
flexible filling that would benefit each company
and possibly, the industry,” says Hawkins.
INNOVATION AND INFLUENCE
Within 12 months of its official 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