In the name of Allah

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

In the name of AllahIn the name of Allah


Dr. H. Abolghasemi

Managing Director

Iranian Blood Transfusion Organization

Plasma for Fractionation IRAN Experience


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.

24.03.2006 Dr. M. Kloft XXXth International congress of ISBT, June 7-12, 2008, Macao

Worldwide plasma market including recombinant products

MRB-Report: Feb 2005Figures 2005 estimated

US

$ b

n.

1.2 1.41.9 2.3 2.6

0.91.1

1.51.5

0.950.8 0.80.9

0.9

0.95

1.91.72

1.080.980.58

0

1

2

3

4

5

6

7

8

9

10

1996 1998 2000 2003 2005

Andere

rec. FIX

pd FIX

rec.FVIII

pd FVIII

Albumin

IVIG (incl. I.m.)

Others

1

24.03.2006 Dr. M. Kloft XXXth International congress of ISBT, June 7-12, 2008, Macao

99.0

88.8

78.5

68.0

58.2

47.4

36.635.5

27.7

19.715.7

9.78.97.4

0

20

40

60

80

100

120

1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010

Worldwide need of immunoglobulins

MRB-Report: Feb 2005

IVIG

(to

ns

)

CAGR 2004/10 = 6,5 %

2


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


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


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.


Iranian Blood Transfusion Organization

• Integral part of the national health system• Blood donation being voluntary and non-

remunerated (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.


IBTO HEADQUARTERS

BTCBCC

BCCBCC

BCC

BCC

BCC

Ministry of Health

A ProvincialTransfusion Center

BTC: Blood Transfusion CenterBCC: Blood Collection Center


Trend of Blood Donation in Iran (1974-2007)

1735000

12,354

1,183,630

1,448,149

746,868

0

200000

400000

600000

800000

1000000

1200000

1400000

1600000

1800000

2000000

1974

1980

1985

1990

1995

2000

2005

2007

Un

its


Trend of Yearly Donation Index in Iran(1974-2007)

24.7

0.39

19.4

22.1

14.7

0

5

10

15

20

25

30

Per

100

0


64

10092

95 95 96 9799

79807777

0

20

40

60

80

100

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

Per

cen

tTrend of Transition to 100%

Voluntary Blood Donation in Iran (1996-2007)


National Blood Program

Donor Screening Blood Testing Q.C

Blood Donor Recruitment Program

National Blood Centers

1) Develop and implement a continuous national awareness-raising 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


• 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


1

2005

2006

2007

0

10000

20000

30000

40000

50000

60000

70000lit

er

year

volume of plasma


Plasma derived medicines used in 2006

IBRF 230 168 7

Total 385 874 128

IVIG (kg) HA (X 10kg) FVIII (MIU)


Flow work for plasma shipment to fractionation center

Assessment of the shipment volume

agreement of medicines regulatory Authority

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)

Licensing

Approval of plasma

contract for fractionation


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

IncreaseQuantity of Plasma

IncreaseTotal Number of Donations


3 kinds of products:1) Haemoctin2) Intratect3) Human Albumin


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.


Automation of lab tests and implementation of the new software


Automation of lab tests


Home made Blast freezers

replaced mechanical freezing.

The plasma core temperature

reaches -30°c within less than 1

hour in blast freezer.


Improvement of the cold rooms and freezing rooms

• Freezer temperature shall be less than -25°C 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 -20°C and -15°C for a maximum of 72 hours, or if it is above -15°C (but colder than - 5°C) in no more than one occurrence, the plasma can still be used for fractionation.


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.

Donor

Fractionation center


Responsibilities and roles of blood establishmentwho 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.


Responsibilities and roles of plasma fractionatorswho 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.


Responsibilities and roles of regulatory authoritieswho 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.


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


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


Thank you

In the name of Allah

Documents

Transcript of In the name of Allah