The differentiating features were experience developing and manufacturing mAbs and a good reputation for quality, and that’s how we ended up choosing Lonza. Its track record in producing monoclonal antibodies (mAbs) is exceptional, and that went a long way for us. I had experience working with Lonza when I was working with previous companies, as did one or two of my colleagues. Corvus’ consultant was also part of the decision to select Lonza.
What made the difference to us was Lonza’s reputation for quality and its expertise in the antibody space. It’s a well-known CDMO that has been inspected routinely by many major health authorities worldwide. The company has an excellent track record, with demonstrated ability to get drugs approved. Beyond maximizing the likelihood of advancing the project, there is also value in the regulatory support. The authorities know Lonza well, so selecting Lonza helped Corvus mitigate risk and promote speed.
Lonza’s brand name is another crucial factor that is particularly valuable for smaller biotechs — it lends credibility and provides comfort to investors and regulators that high quality antibody skills will be implemented. Lonza as our partner inspires confidence in our collaborators and investors, as they are typically very familiar with Lonza’s reputation.
As mentioned, Lonza’s depth of experience with antibodies was the biggest driver in the CDMO selection process. Corvus is developing a unique, engineered IgG1 antibody, so it made sense to look at a partner with deep experience manufacturing antibodies. The fact that CPI-006 fitted Lonza’s antibody platform and processes so well gave us tremendous confidence in their ability to efficiently manufacture Corvus’ mAb.
In fact, the three GMP lots we’ve made for clinical trials have been virtually indistinguishable from one another, along with the 250-L lot produced to initiate our pre-clinical studies and even the earlier 10-L and 15-mL lots made in the lab. That’s important to an emerging company like Corvus, because we need reliability and efficiency. We have a high level of confidence that when our antibody is made it will be the exact same antibody we made before, and this consistency ultimately helps our timelines of course.