In the name of Allah

XXXth International congress of

ISBT, June 7-12, 2008, Macao

Plasma for Fractionation

IRAN Experience
Dr. H. Abolghasemi
Managing Director
Iranian Blood Transfusion Organization
XXXth International congress of
ISBT, June 7-12, 2008, Macao

Product demand
Annual need for blood
products is increasing
Marketing research Bureau 2006-2007

Clotting factors
IVIg
Albumin
Average annual growth rate of factor
VIII, factor IX, AAT, fibrin sealant,
IVIg, and albumin being
3%,1.9%,13%,3.4%,6-8% , 2%
respectively.

XXXth International congress of

ISBT, June 7-12, 2008, Macao

Worldwide plasma market including recombinant

products
10
9
8

US$ bn.

7
6
5

1.72

0.58

0.9

2
1

1.5

0.98
0.8
1.5

1.2

1.4

1996

1998

1.08
0.9

0.8

0.9

1.1

1.9
0.95
0.95

1.9

2.3

2.6

2000

2003

2005

Others
Andere
rec. FIX
pd FIX
rec.FVIII
pd FVIII
Albumin
IVIG (incl. I.m.)

0
MRB-Report: Feb 2005
Figures 2005 estimated
24.03.2006

Dr. M. Kloft

XXXth International congress of ISBT, June 7-12, 2008, Macao

Worldwide need of immunoglobulins

120

CAGR 2004/10 = 6,5 %

99.0

100
88.8
78.5

IVIG (tons)

80
68.0
58.2

60
47.4

40

35.5

36.6

1996

1998

27.7

20

15.7
7.4

8.9

9.7

1984

1986

1988

19.7

0
1990

1992

1994

2000

2002

2004

2006

2008

2010

MRB-Report: Feb 2005

24.03.2006

Dr. M. Kloft

XXXth International congress of ISBT, June 7-12, 2008, Macao

Why contract fractionation?

National blood services play crucial role in
providing safe and adequate plasma to be
fractionated to the very important medicine
including clotting factors,albumin and
immunoglobulines.Although importing these
medicines might be a prompt aproach to furnish
national market with these medicines, worldwide
shortage of these medicines and limited
resources available in countries health care
system make this approach far from ideal
XXXth International congress of
ISBT, June 7-12, 2008, Macao

Why contract fractionation?

An alternative would be either to produce
these medicines locally or use contract
fractionation approach in order to meet
needs of local market
Due to its financial and technical
requirements and considerations
establishing a facility for local production
at least in developing countries has not
been fruitfful
XXXth International congress of
ISBT, June 7-12, 2008, Macao

Why Contract Fractionation in

IRAN?
Cost-effectiveness because of
Rich resource of blood
donors in our country
The number of plasma units
in our blood centers being
higher than the hospital
demand rate.
Decrease in import demand
of blood products including
IVIg and factor VIII.
XXXth International congress of
ISBT, June 7-12, 2008, Macao

XXXth International congress of

ISBT, June 7-12, 2008, Macao

Iranian Blood Transfusion

Organization
Integral part of the national health system
Blood donation being voluntary and nonremunerated (100%)
Centralized. All blood centers throughout the
country are under supervision of IBTO
headquarters. All procedures, kits, and
equipment are the same and follow a similar
standard in all blood centers. All organizational
policies mandated by the headquarters are
issued to all centers.
XXXth International congress of
ISBT, June 7-12, 2008, Macao

Ministry of
Health
A Provincial
Transfusion Center
BCC

BCC

BCC
BCC

BTC

IBTO
HEADQUARTERS

BCC

BCC

BTC: Blood Transfusion Center

BCC: Blood Collection Center

XXXth International congress of

ISBT, June 7-12, 2008, Macao

Units

Trend of Blood Donation in

Iran (1974-2007)

XXXth International congress of

ISBT, June 7-12, 2008, Macao

Per 1000

Trend of Yearly Donation Index

in Iran(1974-2007)

XXXth International congress of

ISBT, June 7-12, 2008, Macao

Percent

Trend of Transition to 100%

Voluntary Blood Donation in Iran
(1996-2007)

XXXth International congress of

ISBT, June 7-12, 2008, Macao

National Blood Program

Donor Screening

Blood Testing

Blood Donor Recruitment Program

National

Blood Centers

1) Develop and implement a

continuous national awarenessraising program to highlight the
importance of regular blood donation
2) Oversee the recruitment, retention,
and recognition of blood donors to
ensure an adequate supply of safe
blood for use by all hospitals in Iran
3) Have accessibility to more than
185 fixed blood donation centers
throughout the country
4) Work in partnership with mass
media to encourage voluntary blood
donation
5) Provide training to blood centers
staff in the field of donor recruitment

1) Follow the program of recruitment,

retention, and recognition of blood
donors
2) Build effective communication
between staff and blood donors
3) Embark on establishing blood
drives in safe places and make efforts
for their being improved so that
demands are met
4) Provide training to volunteers and
exert management to maximize
impact of the public awareness-raising
program

XXXth International congress of

ISBT, June 7-12, 2008, Macao

Q.C

 IBTO started to send the recovered plasma for

fractionation to two fractionation facilities in
Europe following the contract concluded in
2005.
End products are returned to our country.
Our goal is to have a safe and sufficient plasma
derivatives to meet the majority of needs of our
population in the country

XXXth International congress of

ISBT, June 7-12, 2008, Macao

XXXth International congress of

ISBT, June 7-12, 2008, Macao

XXXth International congress of

ISBT, June 7-12, 2008, Macao

Flow work for plasma shipment to fractionation center

agreement of medicines
regulatory Authority
Assessment of the
shipment volume
Audit of the selected
centers by an appointed official auditor from Europe
Audit of the fractionation center by an
Iranian auditor
(appointed by supplier party and Health Minister)

Approval of
plasma
contract for
fractionation

Licensing
XXXth International congress of
ISBT, June 7-12, 2008, Macao

Increase
Quantity
of Plasma

Increase
Total Number
of Donations

Quantity shipment of
plasma can still raise
because
just 16 out of 30 blood
transfusion centers
across Iran have already
been active contributing
to contract fractionation.
We have formulated and
started to implement the
program to increase the
total number of blood
centers eligible to send
plasma
XXXth International congress of
ISBT, June 7-12, 2008, Macao

3 kinds of products:
1) Haemoctin
2) Intratect
3) Human Albumin
XXXth International congress of
ISBT, June 7-12, 2008, Macao

Improvements in IBTO system

Plasma fractionation caused
improvement in the system
specially Documentation,take
PCR sample and cold chain.
More strict standards for
plasma fractionation.
Several external audits from
certified body of Europe.
pushing toward implimentation
of automation in our system.
XXXth International congress of
ISBT, June 7-12, 2008, Macao

Automation of lab tests and

implementation of the new software

XXXth International congress of

ISBT, June 7-12, 2008, Macao

Automation of lab tests

XXXth International congress of

ISBT, June 7-12, 2008, Macao

Home made
Blast freezers
replaced
mechanical
freezing.
The plasma core
temperature
reaches -30c
within less than 1
hour in blast
freezer.
XXXth International congress of
ISBT, June 7-12, 2008, Macao

Improvement of the cold rooms and

freezing rooms
Freezer temperature shall be less than -25C during the
whole storage period.
Because we already have a contract with a European
country, our freezing storage standards shall comply with
European Pharmacopoeia.

The European Pharmacopoeia has a provision stating that if the

temperature of the plasma is between -20C and -15C for a
maximum of 72 hours, or if it is above -15C (but colder than - 5C)
in no more than one occurrence, the plasma can still be used for
fractionation.

XXXth International congress of

ISBT, June 7-12, 2008, Macao

Donor

Look back
Improvement of our
look back system.
Every blood donor can
be recalled if the follow
up is necessary.
System is established
to immediately notify
fractionation center
once a test is positive.

Fractionation
center

XXXth International congress of

ISBT, June 7-12, 2008, Macao

Responsibilities and roles of blood establishment

who expert committee 2007

Collects and analyses the epidemiologic data and surveilance

of donor population based on results of screening tests.
Develops and implements the criteria in selection and interview
of donors.
Performs validated tests (or the tests maybe sub-contracted).
Hemovigilance:Informs plasma fractionator (and when
appropriate the regulatory authority) when relevant information
is obtained.
Collects blood plasma, prepares, freezes, and stores the
plasma, according to good manufacturing practice (GMP).
Prepares the NAT samples following fractionators' specifications
Implements GMP.
XXXth International congress of
ISBT, June 7-12, 2008, Macao

Responsibilities and roles of plasma fractionators

who expert committee 2007

Review the epidemiological data.

Verifies donor selection criteria set by national regulatory authority are met;
may provide additional selection criteria.
Agrees on the tests kits used and audits the virology laboratory.
Hemovigilance: Takes appropriate measures if plasma pool or product
quality is compromised.
Preparation of plasma : Sets the specifications and audits.
Provides the standard operating procedure for NAT samples and performs
(or sub-contracts) the validated testing.
Applies the fractionation methods including viral inactivation following
GMPs and processes described in marketing authorization.
Prepares of plasma product regulatory files
GMP : Audits the blood establishment.
Does pharmacovigilance studies and informs regulatory authorities and
blood establishment when relevant side-effects are found.
XXXth International congress of
ISBT, June 7-12, 2008, Macao

Responsibilities and roles of regulatory

authorities

who expert committee 2007

Review the epidemiological data.
Sets the criteria and inspects the blood establishment.
Approves test kits and inspects the blood establishment.
Evaluates haemovigilance/post-donation reports with regards to
product quality and safety.
Approves and inspects the blood establishment.
Approves the procedure and inspects the plasma fractionator.
Evaluates the data presented in the dossiers prepared by the
fractionator, and inspects fractionation facility.
Reviews and evaluates regulatory files.
Inspects blood establishment and enforces GMP.
Grants the marketing authorization.
Evaluates pharmacovigilance reports with regards to product quality
and safety.
XXXth International congress of
ISBT, June 7-12, 2008, Macao

Notification obligation
:
Deviation is subsequently discovered in any of screening
tests performed on the plasma unites supplied
A regular donor is found to be positive for a marker
although the previous donation was found negative.
(starting look back procedure)
A donation is found to have transmitted an infectious
disease potentialy transmissible by plasma.
We are informed that a donor previousely contributing to
plasma for fractionation has developed an infectious
disease potentially transmissible by plasma
Post transfusion infection following transfusion of blood
components obtained from a donor who has also
donated one or more unites of plasma for fractionation
A unit positive for viral markers has been sent by mistake
XXXth International congress of
ISBT, June 7-12, 2008, Macao

Conclusion : Advantages of plasma

fractionation contract in IRAN
Prevention of 200,000 liters of fresh frozen plasma to be
wasted
35% cost reduction of plasma derivatives and a
reduction in products import with foreign resources
Prevention of patient exposure to foreign biological
products and patient protection against unwanted
infections
Standardization of plasma for fractionation leading to the
improvement of all the procedures in preparation of
blood components
Implementation of a look back system and tracing back
based on the NAT results
XXXth International congress of
ISBT, June 7-12, 2008, Macao

XXXth International congress of

ISBT, June 7-12, 2008, Macao

Thank you

XXXth International congress of

ISBT, June 7-12, 2008, Macao