6
T h e S e r u m S p e c i a l i s t
Since FBS is initially a non-uti-
lized byproduct available from
slaughterhouses worldwide, the
global supply of FBS has perma-
nently exceeded global demand.
Today, conditions are favorable
for uniform and stable purcha-
sing and sale prices at more af-
fordable levels. The problem has
been barriers to trade and the
lack of scientific information to
FBS users. This has generated
a fragmentation of the serum
world, with different supply/de-
mand constellations in different
segments, and price differences
between origins sometimes ex-
ceeding 1,000%.
If FBS is dealt with in a transpa-
rent, customer-friendly, scien-
tifically-correct way and trade
barriers and misinformation
are eliminated, FBS will be more
abundant and less expensive,
and there will be no economic
incentives for criminal activi-
ties. This is how it should be.
Instead, historically, the serum
industry has occasionally in-
terrupted collection, creating
shortages; objected to opening
imports of FBS into the USA
from South America as pro-
posed twice by the USDA; and
misinformed serum users and
regulators about the safety of
Future,
Moving Forward
AS LONG AS IMPORT RULES ARE DIFFERENT BETWEEN
COUNTRIES, AND RESULTING SERUM PRICES VARY BY
UP TO A FACTOR OF 10, TRACEABILITY-RELATED CRIMES
CAN OCCUR. ILLEGAL ACTIVITIES MUST BE STOPPED
BECAUSE THEY NOT ONLY NEGATIVELY AFFECT SERUM
USERS AND THE IMAGE OF THE SERUM INDUSTRY, BUT
THE LONG TERM VIABILITY OF FBS AS A PRODUCT.
ISIA MUST INTENSIFY EFFORTS TO EDUCATE AND TO
PROMOTE THE HARMONIZATION OF INTERNATIONAL
IMPORT RULES.
FETAL BOVINE SERUM HANDOUT
TOPICS FOR DISCUSSION AND
ANALYSIS
7
different sources. The concept
that Oceania is safer is still part
of some marketing campaigns,
even after BSE has been found
to be a spontaneous event in all
cattle populations (Nobel Prize
winner Stanley Pruziner), and
it has been determined by OIE
not to be transmitted by blood
products.
The latest case of FBS fraud, as
uncovered by the French autho-
rities, was elaborate and had a
low risk of being detected. It was
discovered by pure chance and
may have continued indefini-
tely under slightly different cir-
cumstances, like the PAA case.
This type of activity can only be
eradicated by eliminating eco-
nomic incentives, via science,
education, and harmonization.
The damage done to researchers
and other serum users includes
inexact or invalidated results in
research and diagnostics, virus
risks, product recalls, etc. From
a financial viewpoint, losses
include costs of lost research,
plus the difference between
FBS prices actually paid and
the much lower prices that
should have been paid for the
same product if it had been
justly declared. The damage to
competitors consists of lost FBS
business and the cross-effects
on sales of media, reagents,
plastics, and equipment.
The vast majority of serum
companies have always worked
legally, taking traceability com-
pliance seriously and control-
ling their supply chain. With
the traceability laws that have
been implemented by the EU
and other countries, as well as
the new ownership of compa-
nies historically associated with
questionable practices, illegal
schemes are no longer likely to
happen. Today, all serum com-
panies adhere to strict codes
of ethics. However, the risk of
misrepresentation still exists in
cases where the product goes
through a chain of intermedia-
ries. To eliminate potential ille-
gal activities, economic incen-
tives must be attacked at the
root, by the harmonization of
import rules and the education
of serum users and regulators,
based on science.
F
ut
ur
e
,
M
o
v
in
g
F
o
rw
a
rd
NOTE
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AU T H O R : O L E BO DT K E R N I E L S E N , C EO - B I OW EST T H E S E RU M S P EC I A L I ST