Biotech's Sweet Spot
Still, there is something to be said for hitting biotech’s sweet spot. Spun off from the University of Wisconsin, Catalent Pharma Solutions’ services are based on the company’s GPEx® gene-insertion technology.
Catalent has engineered approximately 200 cell lines for manufacturing monoclonal antibodies, which comprise approximately 80% of the company’s projects. It also has the capacity for GMP manufacture of preclinical batches, as well as material to support Phase I/II. It also conducts process development, develops master cell banks, and conducts scale-up.
Catalent has announced its intention to install a 1,000 liter bioreactor later this year, which will support commercial-scale manufacturing at the Middleton, Wisconsin site.
Thanks to upstream productivity, many smaller contract manufacturers are closing in on commercial manufacturing scales. What is holding many back, says Catalent’s GM, Michael Jenkins, Ph.D., is the ability to achieve the level of cGMP compliance required for commercial production. “It’s still a major barrier for most CMOs. And let’s not forget that we still need to purify those proteins. Downstream operations have a good deal of catching up to do.”
Bioinvent, which specializes in product development and contract manufacturing of antibody drugs, has three monoclonal antibodies of its own in clinical trials. The company also created a novel library (n-CoDeR™) of fully human antibodies for use by its own scientists and outside organizations.
Dan Andersson, senior business development director, sees important synergies between Bioinvent’s in-house drug development efforts and projects it conducts on behalf of clients. “We use the same technology platform and facilities, and the two aspects of our business go hand-in-hand. We are able to share what we learn from in-house drug development with our clients, which we believe gives us something of an edge. In that respect, we are different from pure-play CMOs.”
From his perspective, Andersson sees disposables as a major trend that improves the capabilities of contract manufacturers. He notes that single-use equipment, which is firmly entrenched upstream, is making inroads into downstream processing, as well.
Years ago, CMOs and contract research organizations spoke freely of partnering with big pharma and biotech, a fact that irritated some large innovator companies. Today, companies seek long-term relationships with contractors to assure the availability of production capacity and capabilities.
“The approach has definitely matured from the client side,” Andersson notes. “Ten years ago they were looking to the next batch, or perhaps two to three years ahead. Now they’re seeking CMOs that can handle their entire clinical program, and prepare the molecule for the commercial stage.”
Andersson is not alone in observing that cell-culture capacity woes, predicted by nearly every observer of the biotech industry, never came to pass. And before long, he says, 20,000 liter bioreactors might become dinosaurs as productivity improves to 10, 20, and 30 g/L, and more processes become amenable to disposable equipment.