Reproduction permitted for personal use only. For reprints and reprint permission, contact email@example.com.
-- A large whiteboard in the corridor of the Waisman Clinical BioManufacturing Facility
at UW-Madison lists, in color-coded fashion, the schedule for use of the facility's various laboratory suites and research services.
In its very low-technology manner, the whiteboard indicates the success of the facility, which is about to enter its fifth year of operation. Very few times slots are available for the facility's six suites, with a backlog of projects awaiting scheduling.
The whiteboard isn't the only sign of the popularity of the 10,000-square-foot facility within the 251,773-square-foot Waisman Center. Storage rooms and offices are jam-packed.
There seems to be nowhere else to go with supplies, and nowhere else to put staff and lab clients.
"Space is getting to be an issue," says John Keach, business development manager for the facility that was designed to help pharmaceutical researchers advance their discoveries by providing them with lab space that has highly-controlled and extremely clean environments. "We have very little down time."
Of the facility's 10,000 square feet, 6,000 is clean-room space. It has two suites each for microbial products, cell processing, and mammalian products. It also has an aseptic fill suite, quality control labs and a cell bank.
The facility has proved so popular that Keach and facility technical director Derek Hei are starting to talk about expansion, which would likely come in the form of separate space where some of the current suites could be moved to.
"We're a ways off to physical expansion," Keach said. But he envisions something happening in three to five years.
It would be no small venture; the current facility cost about $8 million to develop as part of a $24 research wing added to the Waisman Center. The center is one of 14 national centers dedicated to research on human development and developmental disabilities.
If a split were to occur, it might make sense to have some of the research suites at the University Research Park,
where potential clients may be based, Keach said. Projects that were more closely related to the UW Hospitals would remain in the current facility, he speculated.
Most demand for space is from outside Wisconsin
While it was designed to support Wisconsin researchers, the facility has been more popular with companies and organizations outside the state, Keach noted.
Just three of the 22 companies that have used the facility are Wisconsin companies, Waisman records show. Additionally, UW researchers have used the facility for 13 projects.
Current UW projects include work on a calcium solution for an osteoporosis study. Keach anticipates a neural stem cell project soon, and said the facility is looking to support a project related to Crohn's disease.
The outstate users have come from across the country, taking advantage of a facility which is unique in the Midwest and not common anywhere. It is the only academic facility of its kind in the country. (Others are specific-use labs.) Its niche serves university researchers and very early stage companies that can't afford their own biomanufacturing labs.
Users are fully funding facility
Those users are fully funding the facility's $1.3 million annual operating cost, Keach said.
Among them is Madison-based Quintessence Biosciences Inc.,
which is working with the Waisman to scale up the process of manufacturing injectible-grade EVade ribonucleases - a cancer therapy that doesn't have the side effects normally associated with chemotherapies, said Ralph Kauten, president and CEO of the company.
Kauten, who praised the Waisman staff, said Quintessence's work at the Waisman is in the early stages, focusing on the use of fermentation facilities.
"It's gone extremely well," he said.
The next stage for Quintessence will be to focus on use of the protein purification suites.
But Kauten is somewhat concerned about the popularity of the Waisman facility.
"The Waisman Center is becoming successful to the point that they are outgrowing their current facilities," Kauten observed. "The concern is that increased activities are the Waisman Center will impact the availability of services for companies like Quintessence Biosciences."
He foresees a growing demand for Waisman lab space.
"Having the Waisman Center available is very valuable to Quintessence Biosciences and to other companies focused on drug development," Kauten said. "Given the increasing number of formed through the spin-off of drug technology from the state's academic institutions, the Waisman Center will become even more important and in even greater use."
Cell therapy has longest backlog
While there is a backlog in all areas, Keach said cell therapy has the longest queue, most likely because projects in that room tend to be longer in duration. Most projects take three to six months to complete, with some, such as in the cell therapy area, taking a year or longer. Much of that time, however, involves paperwork, with the actual use of a clean room taking as little as a week.
The ability to handle those kind of projects on a small scale is a specialty for the Waisman facility, Keach said. The exacting nature of the process can help researchers determine the feasibility of their work on a much larger scale, he added.
The facility's help in preparing for the lab work also is invaluable, said Christopher Murphy, a doctor of veterinary science who has been involved in a Waisman project with fellow UW-Madison researcher and UW-Madison veterinary surgeon Jonathan McAnulty.
"Those guys were fabulous," said Murphy, of the UW Schools of Medicine and Veterinary Medicine.
Murphy and McAnulty, in a project sponsored by Anthony D'Allesando, director of multiorgan transplantation at UW Hospitals and Clinics, are working on advancements in the preservation of human organs intended for transplantation.
GMP help called invaluable
There is a tremendous amount of research and documentation work involved in preparing for a Phase 1 clinical trial, Murphy and McAnulty noted, particularly as it relates to the strict Good Manufacturing Practices (GMP)requirements.
"Their guidance was incredible," Murphy said, with McAnulty adding that "with these kinds of projects, you often don't know what you're in for; there is a lot of unforeseen." The Waisman staff did a great job guiding them through those situations, the two researchers said.
Murphy said the existence of the Waisman facility in Wisconsin can be attributed to reducing the costs and quickening the advancement of the project. And, he added, the presence on the UW Hospitals and Clinics grounds was also very convenient -- within walking distance from the veterinary school. As the unforeseen arose, that proximity was helpful in allowed issues to be quickly addressed, he said.
All of the facility's current projects are in the preclinical, or Phase 1 trials, according to Keach. He expects to see some Phase 2 projects next year.
As the facility matures and as its users advance their research, Hei and Keach are keeping an eye on which discipline requires the most lab time. If the facility were to separate some of its suites to another location, it would only make sense to retain the suites that UW researchers are making the most use of, Keach said. "It wouldn't make sense to move what they need off campus," he added. "But any large-scale capacity would almost certainly need to be off-site," he said.
Research Park tenant subsidy discussed
The University Research Park could be an off-site location, with some form of partnership between the park and the Waisman. While it is in "the earliest of stages," Keach said one plan would be to give Research Park tenants a subsidy to cover part of the costs of using the Waisman for manufacturing. The Research Park would not then need to build its own clean space, Keach said, and it could then use the subsidy as a selling point for prospective tenants. Keach said he is hoping to get some such program in place by January.
Research Park director Mark Bugher confirmed that discussions have been held on the subsidy idea, and added that location of a biomanufacturing facility in the park would be a natural addition.
"The heart and soul of the Research Park is the link between research and innovation," Bugher said. A biomanufacturing facility "would be an appropriate fit for us. There are services that our tenants need on a recurring basis that we simply don't have now," he added. Having a portion of the Waisman Clinical BioManufacturing Facility would thus be an asset for the park, he said.