APRIL 2016 | PHARMACEUTICAL PROCESSING
customers is pretty much the same across all the
different industries and all the different types of
products,” said Price.
According to Price, the four manufacturing
steps they follow are:
1. Process Optimization: Take the initial
technology—whether developed internally
by the customer or the CMO develops it for
them—and become familiar with it at the lab
scale. In addition, the CMO needs to be able
to do it reproducibly.
2. Initial Scale-up: Scaling up the process
chemistry and making sure the impurities are
3. Kilo Lab Manufacturing: Producing a
product on a kilo-scale and making sure
everything learned on the previous phase
transfers and occurs the same.
4. cGMP Manufacturing: Producing a product
either for clinical trials or registration batches.
As a whole, PCI Synthesis efficiently capitalizes
on the opportunities nearest them.
“We work with a lot of small, emerging
companies here in the Boston area,” said Price.
“We compete with people all over the world as
well as domestic players.
“The clinical projects we do, where we’re
supplying early phase compounds for clinical
trials—either pre-development or Phase I/II—
the overwhelming majority of those project are
right here locally. We do work with a lot of
Massachusetts-based companies for both medical