Extruded oral forms are important galenic forms
in animal healthcare
because they are particularly palatable
for companion animals.
These forms are very hard to make
and are still rare in veterinary medicine.
Virbac was confronted with this difficulty
when transferring the manufacturing of the product
which was acquired in early 2015 from Elanco, for which the FTC,
the American agency supervising commercial practices,
requires the buyer to be in fully- autonomous control of production.
The manufacturing of this product, which is a parasiticide for dogs,
indicated in the prevention of dirofilariasis
and the treatment of intestinal parasites,
was initially done in Puerto Rico.
In early 2015, Virbac took the decision
to transfer the manufacturing from Puerto Rico
to its US site in St. Louis,
which was completed in late 2017.
This was an especially technical transfer
on account of the complexity of the industrial extrusion process.
It is a continuous process
which requires very particular vigilance
throughout the manufacturing process
to obtain a compliant product with a reproducible dosage.
Despite the short transfer times
required by the FTC,
Virbac honored its commitments,
primarily because we are already doing this process
at the St. Louis site
for a product that is currently in development,
but also at other Virbac manufacturing sites.
This transfer of manufacturing is the culmination
of a project of almost three years
which required several steps: to build a dedicated workshop
within the factory at St. Louis
to accommodate all the equipment required
to manufacture the product,
to acquire industrial experience
by means of numerous visits to the Puerto Rico site,
qualification and validation of the manufacturing equipment
as per FDA requirements.
Finally, to acquire all the analytical techniques
for inspecting the raw materials and the finished product.
Throughout the entire transfer process,
the Group and local Production & Quality teams
worked together closely.
As part of this project to transfer the manufacturing,
I spent a year in the USA as a representative
of the Industrial Operations & Corporate Quality teams,
to support the St. Louis teams
in the key stages of the project:
construction and qualification of the new production workshop,
getting to grips with the extrusion technology
and, finally, producing registration batches.
I found it an extremely enriching experience
due both to the technical complexity of the project
and the collaboration with the local teams.
The site change procedure was defined with the FDA
by a simplified procedure as we decided
to be comparable with the Puerto Rico site:
same batch size, same analytical technique,
same process, same machine.
Today, we received from the FDA
confirmation of the change of site.
We are therefore equipped to produce, with control,
an equivalent product to the one made in Puerto Rico,
all overseen by an effective quality system.
With this manufacturing transfer, Virbac's technical expertise
in manufacturing extrudates,
a forward-looking galenic form for animal health, is confirmed.
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