Lifecycle Management a Key Topic for Vaccines
The
Vaccines
Interest
Group
met
for
a
face-to-face
meeting
Sept.
25
at
the
2018 PDA/FDA Joint Regulatory Conference
to
set
an
agenda
for
2019
and
discuss
topics
of
interest
to
those
in
the
vaccines
community.
Interest
group
co-leader
Sabrina Restrepo,
Director,
Sterile
and
Validation
Center
of
Excellence,
Merck,
opened
the
session
with
an
overview
of
proposed
activities
for
2019.
Following
her
talk,
three
speakers
gave
short
presentations
on
topics
pertinent
to
vaccine
manufacturing.
Antu Dey,
PhD,
Senior
Scientist,
International
AIDS
Vaccine
Initiative
(IAVI)
discussed
the
use
of
different
platforms
for
vaccine
production,
focusing
on
examples
for
viral
vector-based
vaccines
and
recombinant
protein
vaccines.
In
their
vaccine
work,
IAVI
selects
a
specific
cell
substrate
for
suitability
based
upon
the
properties
of
the
target
vaccine
antigen.
Each
cell
substrate
has
technical
and
regulatory
issues
that
must
be
addressed
during
product
development
and
licensure.
Next,
Lindsay Morse,
Associate
Director,
Engineering,
Merck,
discussed
setting
specifications
and
parameters
for
vaccines,
focusing
on
approaches
for
changing
process
parameters
and
attributes
over
the
lifecycle
of
the
product.
Morse
noted
that
the
long
lifecycle
of
vaccines
necessitates
periodic
changes
to
parameters
and
attributes,
and
that
the
development
of
standardized
principles
for
legacy
vaccines
could
be
useful
for
the
industry.
Restrepo
then
provided
a
short
talk
on
vaccine
lifecycle
management
with
an
emphasis
on
ensuring
continuous
supply.
Changes
to
an
approved
product
are
driven
by
multiple
reasons,
including
continuous
improvement,
capacity
expansion,
innovation
and
routine
requirements.
For
a
product
used
globally,
these
changes
need
to
be
reviewed
by
multiple
regulators
working
under
different
regulatory
systems.
This
can
lead
to
an
increase
in
the
time
from
submission
to
approval.
The
leaders
of
the
V
accines
Interest
Group
encourage
those
interested
in
vaccine
manufacturing
to
consider
attending
PDA’s
inaugural
Biopharmaceuticals Week
in
May.
The
interest
group
will
also
convene
at
the
2019 PDA Annual Meeting.