Last week, the staff at Pharmatek Laboratories (San Diego, CA) graciously hosted an event for media and small-pharma representatives that provided a rare tour inside its new high-potent, cytotoxic (HP/C) facility. The 16,000-square-foot addition to their existing lab space was to be triple-cleaned and then forever-closed to visitors the following day. It was a chance to see state-of-the-art in containment technology and facility design up close.
The expansion seems to have come at a very good time and place. The amount of research into discovering high-potent and/or cytotoxic compounds, mainly those targeting cancer, is rising quickly. And with no other West Coast lab facilitiy offering early-phase development services for these substances, the lab aims to fulfill capacity quickly. Already, according othe company, Pharmatek has tripled its staff during the past 4-5 years (and I found it interesting that the facility design factored in “perks” that were meant to “keep their scientists happy,” such as a gym and big windows in the analytical lab).
Aesthetics aside, it was easy to spot the major differences in the technological details of an HP/C lab versus the traditional Class 100,000 suites. First and foremost, let me just announce clearly my heightened respect for all who gown up every day, probably more than once a day, in head-to-toe cleanroom attire: you make it look easy. The facility itself was designed with careful consideration to the flow of materials, personnel, and equipment using “serpentine”-configured differentials in pressure from area to area. The manner in which the suites were constructed, from the welded-sheet vinyl flooring to the hardlid ceilings was also interesting and all were details I had not come across before. And the extent in the use of disposable technology was impressive, especially in the bag-in/bag-out setup for the equipment and material transfer. Each unit process was designed to be enclosed within a flexible, disposable bag, complete with gloveports and filters.
It will be interesting to watch how other advances in disposables, isolators, barriers, and cleanroom design will make their way into the growing HP/C contract laboratory market. And if you come across unique technology, drop us a note and let us know.