BioPharm: As industry increases its focus on biologics, has the complexity or scope of your projects changed, and if so, in what ways?

Hancock: Yes, they have. On one hand, we have seen larger companies that have increased the number of projects that they outsource and on the other we're seeing virtual companies that outsource everything. With the virtual clients, we have contracts now where we're performing all the development work including the very early stage work. A typical company in this category is a small biotech company that has some laboratory capacity and a maybe a small vivarium. A number of biogeneric and biobetters [companies] have a few people in offices and no laboratories at all. They're asking us to do the entire development: generating the gene of interest, the cell banking, all the process development and stability, and container compatibility studies. These projects move very quickly. The timelines are very aggressive, and the projects call on all the resources that we've developed.

They're also looking for an edge. Some are happy to have a molecule that's the same as what's already marketed, while some are really looking for a biobetter. For example, if the innovator is in a vial, perhaps they want to market it in a single-use syringe, or they want a formulation change so that instead of daily injections, the patient can get weekly or monthly injections. And we have some technology around that space. One of our former clients, Altus Technologies, developed a process for crystallizing a wide variety of proteins. They developed a crystallized form of human growth hormone that allowed patients to get injections once a week [instead of once a day]. We were able to acquire that portfolio of products and IP, and we're now offering that to clients who want a formulation change that will give their product an advantage in the clinic. Several CMOs have unique, proprietary technologies. In addition to the standard contract manufacturing offerings, they may have a proprietary cell bank or purification technology. On the formulation side, we have this crystallization technology, which has been of interest to a number of our clients who are looking for delivery advantages or solutions.

Hancock: We had QbD in place for several years before our customers started regularly asking for it. What we like about it is we have some clients who want us to go from a small-scale process as quickly as possible to making GMP material for a clinical trial. Some are resource constrained and are willing to take risks to try and move as fast as they can. We try to accommodate them as much as possible. The challenges are, if you get lucky and it works, great, but if not, you have to figure out why. QbD is really developing a rational process so that by the time you get to GMP production you've had a chance to do some engineering runs that allow you to identify the variables and specifications you need in place. You've had a chance to do a shakedown of the process and find out what it's able to deliver before you begin the critical manufacturing runs. We're big proponents of QbD and are happy to see more and more industry leaders adopting it.