Producing equine plasma - Veterinary Practice
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InFocus

Producing equine plasma

Veterinary Practice visits a highly specialised company in Cumbria and hears of its struggles with product licensing

VETERINARY Immunogenics
(VIL) is a name which in recent
years has become familiar to almost
all UK and Irish veterinary surgeons
engaged in equine practice.

A family-owned business, it
produces and supplies fully licensed
hyperimmune equine plasma products
to the profession.

Tom Barr, the managing director,
identified a need for such products
whilst a partner in veterinary practice.
“Our own small dairy farm locally was
no longer viable, so a decision was made to
convert its purpose to
equine plasma
production.”

Tom first came
across commercial
equine plasma at the
annual convention of
the AAEP in California
in the early 1990s and
subsequently sought
advice from and visited various
locations in USA.

A system and work procedures for
the production, storage and despatch of
product were established and he
acquired a few suitable horses, pheresis
and other equipment, and invested in
refurbishment of the buildings – and
VIL was launched in 1993.

The necessary Home Office
Licences were applied for and granted.
Shortly afterwards Tom retired from his
veterinary practice in order to ensure,
along with the help of his wife Eileen,
the sustainability and growth of the
business.

Then in 1997 came a hammer blow.
The Veterinary Medicines Directorate
(VMD) advised Tom that as the VIL
products’ labelling and literature carried
medicinal claims by implication, so VIL
must go through the formal process of
obtaining product licences (marketing
authorisations) for each of them, as well
as a manufacturing licence.

Tom pointedly observes, “At that time and even today the licensing
process is often only vaguely
understood by many vets in practice.
They simply do not understand the
benefits to their patients of our
marketing authorisations (MAs), nor all
that was required to obtain those
authorisations.

“The VMD allowed us several
months to gain the licences, during
which time we scrutinised all of our
production processes and generated a
whole range of new data in order to demonstrate that our products, which we
were confident were
potent, safe and
efficacious, satisfied all
of the requirements
governing licensed
quality, safety and
efficacy.”

The challenges

The company knew that
its products were effective in the field, and an absence of validated complaints
also meant that they were safe to use –
but MA dossier generation was a whole
new challenge! The learning curve was
steep; understanding the twists and
turns of the regulatory process led Tom
to many long nights of study and
frustration.

The formulation and production
processes had to be revisited and viewed
against the stiff legislative requirements
necessary to formally establish the
production protocol and “final product
specification” (FPS), so that every batch
produced satisfied the criteria of
“constant quality”. In addition, a clear
protocol for the regular monitoring and
recording of the management, health
status, vaccination status and freedom
from specific diseases of each donor
horse had to be put in place.

Expertise, in particular a highly-
regarded human plasma consultant, had
to be bought in, scientific papers and
other bibliographic references and data
located, studied and utilised as dossier
content – or discarded.

Above all, new safety and efficacy
trials in the UK had to be designed,
approved, conducted, reported and
evaluated for writing-up in the dossiers.
And then experts had to be
commissioned who would scrutinise
and write separate expert reports on
each set of completed dossiers.

Tom Barr remarks: “Many vets in
practice, including me when in practice,
simply don’t realise that in order for a
licensed medicinal product to be
supplied to them, that product must
have been produced in a fully licensed
manufacturing facility.

“In other words, in a facility which
must hold a current Good Manufacturing
Practice (GMP)
Certificate, and
which satisfies
all of the GMP
criteria laid
down in the
legislation and
satisfies the
periodic site
inspection audits carried out by VMD
inspectors.

“Even that is not the end of the
story. Although VIL’s quality assurance
and quality control personnel have
monitored and approved every step in
the production process of every batch,
the legislation also requires that every
batch record must be passed to an EU-
authorised ‘qualified person’ (QP) who
will scrutinise the raw materials, donor
horse details, production processes,
assay and test results and other criteria
defined in the MA and FPS. Only if the
QP is satisfied with all of the data will
he approve a batch for sale.

“Overlying the whole process is a
Site Master File and sets of authorised
standard operating procedures (SOPs),
work instructions, training, periodic
audit documentation and other
controls.”

The products

VIL currently produces two licensed
products:

  • Hypermune is a hyperimmune equine
    plasma obtained from donor horses
    (each batch from a single donor) which
    have been frequently vaccinated with an
    authorised range of vaccines, and
    contains licensed high potency levels of
    IgG and total protein for use in young
    foals for the prevention and treatment
    of failure of passive transfer of
    maternal immunity; and
  • Hypermune-RE is an equine
    hyperimmune plasma with the same
    high potency levels of IgG and total
    protein as Hypermune plus a defined,
    high specific antibody level against
    Rhodococcus equi, and is authorised for the
    prevention and treatment of failure of
    passive transfer and also for use in foals
    with normal passive transfer or failure
    of passive transfer, in order to raise the
    level of Rhodococcus equi antibodies.

Tom Barr is enthusiastic about his
products. “We are confident that we
supply equine veterinary surgeons with
licensed, consistently high-quality, safe
and efficacious equine plasma products.
Each batch is produced from a single
demonstrably healthy donor horse, so is
readily traceable should a suspected
pharmacovigilance issue ever arise.”

Family-owned

So where is VIL today? It remains a
family-owned business with a well-trained team. Tom Barr, as managing
director, is primarily responsible for
company policy, overall quality
assurance systems and compliance with
regulatory requirements and document
control.

His wife, Eileen, is the co-director
who looks after the accounts as well as
being involved in quality assurance and
in other aspects of the business.

Horse management, feeding and
health are the responsibility of son
Jason along with Ruth Smith who has
been with the company for 16 years.
Pheresis is routinely undertaken by the
Home Office licensed personnel, Ruth,
Jason and Maria.

Linda Chappelhow is responsible for
quality control (QC). She collates all QC
data from plasma harvests onto official
documentation, ensures full compliance
with GMP for each individual plasma
harvest as well as all associated
peripheral activities.

VIL contracts out some routine
laboratory testing which the MA
requires to be carried out on every
batch. However, it has now developed
some of its own laboratory facilities and
these are in the hands of Nichola
Reynolds.

The company’s qualified person is
veterinary surgeon Bas Hardy who has
spent most of his career in the
veterinary pharmaceutical industry.

VIL also utilises the services of
consultants such as Dr Jonathan Pycock
who provides additional veterinary
technical expertise for the company’s
customers in support of Tom and who
also advises and assists on various
matters, including the interpretation and implementation of changing regulatory
requirements as well as the operation of
the company’s pharmacovigilance
system.

Tom Barr states that VIL will
continue to produce high-quality equine
plasma products. “We have researched
equine plasma products containing
specific antibodies against other equine
disease conditions but the high costs
required to generate complete dossier
data, when offset against the likely sales
returns, have so far prohibited their
progress through to the full-scale trials
necessary to establish efficacy and safety
whereby an MA can be obtained.

“A number of specific projects have
been identified and are currently on hold
pending emergence from the current
economic climate. However, VIL has
never rested on its laurels and remains a
progressive company which always
welcomes observations from its many
clients and staff in universities and other
organisations, which will improve equine
health and welfare and enhance the
services provided and the well-being of
veterinary practice.”

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