There's a company out there called, Pristine Bioproduction.And it's run by a Genentech alum named, Tim Matthews. He's an early-stage contract manufacturing organization and their edge is single-use bioreactors.
Here's the deal. The global mAb market is valued at 15.6 billion and is projected to double in the next 5-years to almost 32-billion by 2017. Between now and then a lot of folks are going to be entering the market with products, and a lot of the manufacturing capacity is tied up with big biotech.
The reason you outsource your manufacturing is so you can focus on your core competency: R&D and process development. You let the big guns handle your manufacturing and commercialization strategy.
Guys like Tim have been down that road. In fact, the cool part about Pristine is that they offer agility with single-use technologies, which translates to greater speed and lower costs.
Questions Tim gets all the time are:
- How can I be certain my CMC strategy is going to fly?
- How do I best ensure that my manufacturing/supply-chain partner is the best fit?
- How can I be be assured that disposable technologies will work for me?
Those other people's questions