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Our Team
WHO Expert Committee on Biological Standardization.
[typhoid]
This
report
presents
the
recommendations
of
a
WHO
Expert
Committee
commissioned
to
coordinate
activities
leading
to
the
adoption
of
international
recommendations
for
the
production
and
control
of
vaccines
and
other
biological
substances
,
and
the
establishment
of
international
biological
reference
materials
.
Following
a
brief
introduction
,
the
report
summarizes
a
number
of
general
issues
brought
to
the
attention
of
the
Committee
.
The
next
part
of
the
report
,
of
particular
relevance
to
manufacturers
and
national
regulatory
authorities
,
outlines
the
discussions
held
on
the
development
of
revised
WHO
Guidelines
.
Specific
discussions
took
place
on
the
development
of
WHO
guidance
on
the
nonclinical
evaluation
of
vaccine
adjuvants
and
adjuvanted
vaccines
;
the
quality
,
safety
and
efficacy
of
typhoid
conjugate
vaccines
;
and
the
quality
,
safety
and
efficacy
of
biotherapeutic
protein
products
prepared
by
recombinant
DNA
technology
.
Subsequent
sections
of
the
report
provide
information
on
the
current
status
and
proposed
development
of
international
reference
materials
in
the
areas
of
vaccines
and
related
substances
;
blood
products
and
related
substances
;
in
vitro
diagnostic
device
reagents
;
and
biotherapeutics
other
than
blood
products
.
A
series
of
annexes
are
then
presented
which
include
an
updated
list
of
WHO
Recommendations
,
Guidelines
and
other
documents
on
biological
substances
used
in
medicine
(
Annex
1
)
,
followed
by
a
series
of
WHO
Guidelines
adopted
on
the
advice
of
the
Committee
(
Annexes
2
-
4
)
.
All
additions
and
discontinuations
made
during
the
2013
meeting
tothe
list
of
International
Standards
and
Reference
Panels
for
biological
substances
maintained
by
WHO
are
summarized
in
Annex
5
.
The
updated
full
catalogue
of
WHO
International
Reference
Preparations
is
available
at
:
http
:
/
www
.
who
.
int
/
bloodproducts
/
catalogue
/
en
/
.
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