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Pertinence
Offers Solutions To Maximize Vaccine Production
General Manager Frederic Halley Talks to Pharma DD
With
the looming potentiality of a global influenza
pandemic, vaccine manufacturers must be able to supply
sufficient product—quickly. To that end, makers of
vaccines are taking steps to streamline their
manufacturing processes. Pertinence is a software
company offering solutions designed to help such
companies maximize production efficiencies. Frederic
Halley, Pertinence’s General Manager, recently
talked to Pharma DD about its activities in
this area.
As a
specialist in manufacturing intelligence, Pertinence
works with many different industries. But one of its
core businesses encompasses vaccine development.
Pertinence works with vaccine manufacturers on
production bottlenecks to help them achieve bigger
yields. Currently its largest customer in the vaccine
area is Sanofi-Pasteur—representing a three-year
partnership. Pertinence works with two other vaccine
developers—an undisclosed human vaccine company; and
the animal vaccine arm of Wyeth.
Pertinence
offers two major software products tailored toward
vaccine developers. The first helps them understand
what works—and what doesn’t—during the
production process, allowing the manufacturer to
figure out how to obtain the highest yield and
best-quality production. The second allows for the
subsequent application of these best-practice models,
integrated in real time, during the production
process. Beginning with a run’s very first batches,
Pertinence’s solutions can help ensure that vaccine
manufacturers nail down their optimal set up. “If
their R&D department determines that the vaccine
is going to work, then the challenge becomes: ‘How
do you move from having one scoop (of product) in the
lab, to producing millions of doses for an entire
population?’ The ability to answer that question is
one of our software’s core values for customers,”
said Halley.
As
Halley pointed out, “Our customers have realized
that it is much better to begin working with our
software solution at the development phase; it is more
interesting to build a model of the vaccine production
process early on. Then, they can subsequently
use that knowledge (gained very early in production)
to ramp up more quickly, getting higher volumes much
faster.”
According
to Halley, his company’s solutions allow customers
to gain a better understanding of best practices to
use this knowledge to adapt their processes midstream.
Says Halley, this process can take different forms.
“Particularly, what I have frequently seen in a lot
of different vaccine projects is the relationship
between the raw material and the production
process--how long do you incubate, and at what
temperature—there are so many different process
parameters that can be adjusted. You can get the best
result, all the time, by optimizing your process to
complement the exact characteristics of the raw
material.”
Pertinence
can also help with the transfer of a handful of
validation batches to replicating them for commercial
production. Its solutions can help elucidate the
structure of the manufacturing process much faster, so
that companies can achieve their volumes faster. As
Halley points out, “The first challenge is to find
the solution R&D-wise. But obviously the second
challenge becomes, how do we ensure that the vaccine
company will be able to produce millions--and most
likely tens of millions--of doses at the right
time?”
"It’s
important to note, Pertinence’s software solutions
are very user friendly—they can essentially be used
right off the shelf. The first product, used during
discovery, typically requires a few days of training,
but customers come up to speed very quickly. The
second product, used during the production process
itself, is similarly simple." But if the customer
wants to integrate Pertinence’s solution with their
existing system, a nominal amount of local
customization may be required.
The
cost for one of Pertinence’s solutions varies by the
number of users, ranging from $100,000 to $300,000.
“We’ve seen that the payback on this is usually
very good. Being able to avoid scrapping just a couple
of batches usually results in a very high return on
the (software) investment.” According to Halley,
that is precisely one of the reasons why Pertinence
initially targeted the vaccine industry: The stakes
are very high and the manufacturing process is
extremely complex.
While
Pertinence also works with some more traditional
pharma companies (e.g., Sanofi-Aventis), it
tends to focus heavily on vaccines. Said Halley, “At
the moment, we are actively pursuing several vaccine
companies. They all have extremely ambitious plans to
ramp up production when it comes to the flu. It’s a
huge area of critical need, and we’re working with
them to help address it.”
For
more information on Pertinence’s solutions, please
visit www.pertinence.com/.
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