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Texas A&M System, Xoma to Devise Methods, Build GMP Lab to Make Proteins, Antibodies

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The Texas A&M University system and therapeutic antibody company Xoma plan to co-develop new ways of making proteins and antibodies, and design and build a GMP facility in Texas to manufacture them, university and company officials said this week.
 
The collaboration could provide TAMU with additional research capabilities and expertise in an area of unmet need at the school, and potentially allow the university to score commercial and government biomanufacturing contracts, a university official said this week.
 
The partnership could also bolster translational research and technology-commercialization efforts in the TAMU and University of Texas systems, and help drive economic development in the state in the area of protein therapeutic development, the official said.
 
As part of the alliance, TAMU and Xoma, based in Berkeley, Calif., recently signed a memorandum of understanding, announced last week, to study the feasibility of co-developing and manufacturing antibodies and protein-based therapeutics for human and veterinary applications.
 
Specifically, TAMU and Xoma are currently discussing ways to co-develop “next-generation systems and processes to improve and accelerate” protein and antibody manufacturing, they said in a statement.
 
To enable this, the organizations plan to design and construct a GMP manufacturing facility on TAMU’s main campus in College Station that would incorporate protein-manufacturing techniques recently developed by both TAMU and Xoma scientists.
 
The full details of the collaboration have yet to be worked out and are the subject of current discussions between the school and the company. For instance, it is unclear whether Xoma will fund part or all of the construction of the new GMP facility
 
“At this point it would be premature” to disclose any details, Pat Scannon, executive vice president and chief biotechnology officer for Xoma, told BTW this week. “All I can say is that both [TAMU] and Xoma are very interested in making this work. They want to create this presence in Texas, and they certainly have land and a number of features that are a part of this. But the details of how we’ll share resources will be worked out.”
 
Completing the Bridge
 
Brett Giroir, vice chancellor for research for the TAMU system, told BTW this week that the university has recently invested in several areas intended to build a bridge from the earliest stages of drug development to clinical trials.
 
Examples of such investments, all on TAMU’s main campus in College Station, include the Texas A&M Institute for Genomic Medicine, which opened in 2006; and the Texas Institute for Pre-Clinical Studies, which in 2009 plans to open a 112,000-square-foot GLP facility with imaging; a large animal hospital; animal housing; surgical laboratories; pre-op and recovery rooms; an interventional catheterization laboratory; and incubator space for start-up companies.
 
However, according to Giroir, there is a “hole in the integrated process” that needs to be addressed: manufacturing.
 
“In small-batch, non-GMP manufacturing, if you have a target and you need a panel of 20 monoclonal [antibodies], how do you do that?” he said. “How do you even get it scaled a little bit, and be set so that if you go to a clinical trial, you don’t have to go to Singapore or China to get it made in reasonable batch size?”
 
To meet those challenges the university had been internally discussing for some time constructing a commercial-scale GMP-approved manufacturing plant on or near its campus.
 
“In order to complete our portfolio of an integrated, complete bench-to-patient portfolio, it is very important to put an academically associated GMP-manufacturing plant here,” Giroir said.
 
But academic outfits are generally not in the business of building or operating large-scale biologic production facilities, so TAMU began seeking commercial partners to get behind the project. It may have found such a partner in Xoma, which Giroir had been familiar with from previous stints with other academic institutions and the Defense Advanced Research Projects Agency prior to his employment with TAMU.
 

“Perhaps more importantly will be the ability to move academic discoveries down the pipeline. That’s really a critical piece, not just for Texas A&M, but the entire state of Texas.”

“I have a good understanding of the abilities and commitment of [Xoma] in protein manufacturing,” Giroir said. “They are very committed to process optimization and all the things that will help build the next generation of biopharmaceutical manufacturing capabilities.”
 
The construction of such a manufacturing facility, which would likely be located adjacent to the Texas Institute for Pre-Clinical Studies on TAMU’s main College Station campus, could have multiple and far-reaching benefits not only for the TAMU system, but also for the University of Texas system and the state of Texas, at least in terms of biotech-based economic development.
 
“First, it would be a really strategic national resource for biomanufacturing, particularly for proteins and other biologics that have strategic national defense importance,” Giroir said. “Second, and perhaps more importantly, will be the ability to move academic discoveries down the pipeline. That’s really a critical piece, not just for Texas A&M, but the entire state of Texas.”
 
For example, Giroir said that TAMU and the UT system are working together very closely to create an integrated process for translational research and technology development and commercialization.
 
“UT is much more known for the medical school side, and a lot of the upstream side in terms of target selection and computational biology; whereas we sort of fit in the intermediate side with animal models, GLP facilities, biomarkers, and engineering and manufacturing,” Giroir said.
 
The new facility could provide promising university biotechnologies or recent spinout companies with a way to manufacture biologics for testing and proof-of-concept work, and possibly even pre-clinical or clinical trials, which would add value to them and make them more attractive licensing or investment targets.
 
“And from a state point of view, I think it also provides a little bit of a magnet for biotech,” he said. “Companies know that within two blocks they can come and get all their animal models and GLP studies done; and then actually have pilot-scale or commercial manufacturing all in the same place.”
 
In June, before the Xoma announcement, TAMU said it had forged a broad-based research and development partnership with another company, Austin-based Introgen Therapeutics, in the area of biotherapeutics, vaccines, and delivery systems.
 
This alliance, which is spearheaded through Introgen subsidiary Introgen Technical Services, is also an important piece of the puzzle for TAMU in terms of adenoviral-based therapeutics and cancer therapeutics. Unlike Xoma, Introgen has no products on the market and doesn’t have the same kind of resources that Xoma can provide for developing the GMP manufacturing facility. Despite this, the company “has really set the regulatory standard for adenoviral products, and [has] been through Phase III trials,” Giroir said.
 
Flexible Facilities
 
For Xoma, the relationship with TAMU will allow it to access research expertise and know-how that can help it further develop its biomanufacturing capabilities, Scannon said.
 
Specifically, he said that one of the difficulties in biotechnology is the expense of building new manufacturing facilities. “When you’re talking about building a facility that has 10,000-L or 20,000-L reactors you’re talking between a half-billion and billion dollars,” Scannon said. “And it can be five-plus years to get a facility validated and up and running.”
 
According to Scannon, this is an especially salient point when one considers how quickly technology changes, and how most manufacturing facilities are ill-equipped to adapt to such changes. “You’ve got piping and stainless steel embedded in concrete, so modifying the facilities to adapt to technological changes is very difficult,” he said.
 
Scannon said that Xoma and TAMU are discussing designing a flexible, adaptive facility that would involve, for instance, disposable fermentation systems and other new methods of biomanufacturing that could reduce cost and increase production.
 
“Working with Texas A&M faculty and researchers to develop downstream methods of fully integrating the manufacturing process is a win-win situation,” Scannon said. “We bring a state-of-the-art thinking on manufacturing operations; and they bring novel thinking in terms of innovation that goes beyond what we would ordinarily do as a company.
 
“Once we incorporate that into the existing design, we can take the lessons learned and think about designing even larger facilities in which we would incorporate the innovations that were developed through this collaboration,” he added.
 
Such a collaboration, like a traditional sponsored research agreement, is bound to produce new intellectual property in the area of biomanufacturing, Scannon said.
 
“This is an unusual situation since it is a new model,” Scannon said. “Texas A&M has IP; Xoma has IP; and there is a fair amount of trade secret information. We need to anticipate that new IP will derive from this relationship, and accordingly, that will become a very important part of the discussion.
 
“Both parties are bringing something to the table, and we expect both to derive benefit,” he added.

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