Phase II and then commercial manufacturing, processes and equipment gets “locked down” and are
Particle Sciences is also doing a lot analytical work
in support of Phase III projects, which will inevitably
lead to an FDA audit of their facilities. “We have in-
vited them in,” says Mitchnick, “they just don’t have
the bandwidth right now.”
Particle Sciences has become a successful drug
development service provider by differentiating itself
from other companies in both the technologies and
approaches they use.
Mitchnick explains, “Our approach differs because
we are not a platform company – we don’t have a
hammer and everything has to be a nail. We have
a very methodically assembled team and an array
of technology solutions to address recurring drug
delivery problems. Our portfolio continues to grow
through both in-house innovation and in-licensing."
Particle Sciences currently has four in-licensed
technologies. "Everything we have in-house we do
ourselves," he states. "We don't take on a project and
then hire someone else to do it."
What sets Particle Sciences apart from other ser-
vice providers is that when a client shows up with a
problem, they don’t have a predetermined solution.
“We listen to their problem. We listen to their goals,”
says Mitchnick. “We delve fairly deeply into what they
need as far as IP. Sometimes this involves using their
IP, ours or using public domain IP - it's a project by
Particle Sciences' development staff are
divided into a few divisions – Formulation,
Analytic/Characterization, Quality Production
and Project Management. Most projects that
come to Particle Sciences naturally originate in
the formulation division, but benefit from the re-
sources of all groups.
Mitchnick provides more details as to how client’s
needs are handled. “When a client shows up they are
assigned a project manager. They are also assigned a
formulation lead and an analytic lead. In most cases
formulation drives the project. These three people
stay with the project for its entire life. These project
leads can call in additional resources as needed.
"We could have five analytics people working on a
project – but are all working under that one analyti-
cal leader. And within our groups, the senior people
are designated as project leads - the others will even-
tually also be able to be project leads.”
As mentioned, Particle Sciences is expanding their
services to include Phase III and commercial man-
ufacturing at their present location in Bethlehem,
Mitchnick offers more details, “In terms of the busi-
ness, we are going to dive deeper into what we do.
This means becoming more of a Phase III and com-
mercial producer of non-commodity products. We
are going to do things around technology for which
there are not good CMOs out there yet. There are
both good opportunities and significant competitive
He continues, “It’s more about the interface of spe-
cific technologies and dosage forms for which there
are not good CMOs. We see opportunities in areas
around complex formulations where there are, at
most, only a handful of companies operating. These
projects could in fact be very large volume - though
often they are not.
"We are not necessarily aiming for the largest market segments just, from our perspective, the most