says Price, “we had to get out of the contracts that were
money losers It took a solid three years to do that.”
WHAT GOES AROUND COMES AROUND
By 2010 Price was again looking at how to grow the business. He came back to his idea from almost 10 years ago –
the biotech industry.
“Sure enough, many of our competitors were doing such
business," says Price, “and here we were an incredible man-
ufacturing asset right in the backyard of the one of the big-
gest biotech clusters – but we
are not servicing them at all.”
“Everyone else is coming
from overseas and around the
country to do business and
here we are, and I thought
that was ridiculous.”
Price also realized that
the company as it was had
deficits. They had an infra-
structure – the site and the
facility. But they did not have
the organization specifically
in sophisticated chemistry
and analytical and regulatory
“2009, 10 and 11 were spent
developing the organization; the
systems and the capabilities to
serve that market,” says Price.
Today, PCI operates in two
The first vertical is their
commercial business which manufactures approved new chem-
ical entities and generic APIs. PCI has six approved products it
is currently manufacturing and another ten in its pipeline.
PCI’s commercial APIs run from half a kilo a year to 10 metric
tons which demonstrates the wide scale of manufacturing capacity the company offers, dependent on the type of product.
To help the company meet its goals they have upgraded
their clinical suites to handle APIs for injectables.
“We have implemented new procedures and SOPs, and
installed laminar flow hoods and air handlers. We have four
injectable projects going on simultaneously,” says Price.
The second vertical that PCI operates in is process research and development on a contract basis. Many are small
to mid-size emerging small-molecule pharmaceutical companies and many are local in Boston.
“We are doing everything for them,” says Price. “We are a
solid outsourcing partner for them – some are coming to us
post-discovery and we supply them with pre-clinical material,
we do all the process optimization – then supply them with
clinical materials and hopefully will be their commercial man-
ufacturer down the road if and when they get approval.”
Price says PCI’s capabilities can be summarized fairly easily.
First they have very strong chemistry resources at their
Second, they have a lot of resources devoted to project
management and project control. In this business, Price
says, it’s very critical to get a project into the clinic, because that step triggers a lot of investment money.
“Some people in the business view what we do as a commodity. If you need to pick a partner – and your next round
of money depends on getting your product to the clinic - it’s
really not a commodity,” Price adds.
Third, Price points to PCI’s scale.
“We have equipment up to 2000 gallons,” he says, “we
have clinical suites that operate in glassware – and we have
everything in between. So whatever your phase, we have
the equipment and it can be done under one roof.”
Price continues, “It’s been very typical in this industry to
use a small lab-scale company, then to a clinical stage com-
pany, then to someone who can do the commercial scale
manufacturing. We offer all under one roof – and we have
the infrastructure to do it – you don’t have to move your
product and deal with the possible risk in that.”
Looking ahead one of Price’s primary goals is to get the
word out about PCI and its capabilities.
“From a tech standpoint and equipment standpoint we
might not be a fit for everyone but everyone should know of
us,” he says. “That’s my primary goal – we have tremendous
capacity. We have installed new equipment and are getting
ready to install more equipment. And when our next expan-
sion is done we will have close to 23,000 gallons of capacity.
We are unmatched – nobody in the greater Boston area can
bring to bear the resources that we have in terms of chemis-
“Over the next 5 years we want to create value – in order to do
that we have to execute on the commercial pipeline and utilize
the capacity that we have and develop ourselves as the leading
small molecule manufacturer in the greater Boston area.” ■
■ Newburyport, MA Facility
• 65,000 sq. ft. facility
• Total capacity of 18,000 gallons
• Pilot plant with vessels ranging
from 50 gallon to 200 gallon
• Production plant with vessels
ranging from 500 gallon to 2,000
• Temperature capability of –50°C
• Materials of construction: Hastelloy,
glass lined, stainless steel
• Filtration/Drying: Hastelloy PFNs,
Titanium Centrifuge, rotary and
• Filtered air handling in all manu-
• Validated purified water system
• Complete onsite QC/QA support
• FDA inspection August 2011
■ PCI Also Operates a Devens, MA R&D
• Process research, development, and optimization
• Non-cGMP kilo laboratory capabilities
• Small scale manufacturing and scale-up services
• Complete on-site QC support - HPLC, GC, FT-IR,
• Six separate laboratories - Includes 28 hoods
• Glassware to 100L
• Thin film evaporation, lyophilization, flash chro-