the ‘achilles’ project:
DESCRIPTION
The ‘Achilles’ project: a WHO initiative to support quality in the manufacturing of plasma for fractionation. Dr Ana Padilla, Blood Products & related Biologicals Essential Medicines and Pharmaceutical Policies Department Health Services and Systems Cluster World Health Organization. - PowerPoint PPT PresentationTRANSCRIPT
The ‘Achilles’ project: The ‘Achilles’ project:
a WHO initiative to support quality in a WHO initiative to support quality in the manufacturing of plasma for the manufacturing of plasma for
fractionationfractionation
Dr Ana Padilla ,Blood Products & related Biologicals
Essential Medicines and Pharmaceutical Policies DepartmentHealth Services and Systems Cluster
World Health Organization
WHO Norms and Standards: WHO Norms and Standards:
Blood Products & related BiologicalsBlood Products & related Biologicals
WHO Expert Committee on Biological Standardization
WHO Blood Regulators Network
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OUTLINEOUTLINE
WHO Essential Medicines List
Plasma for Fractionation
The "Achilles" Project: Rationale and scope Project goals WHO action plan Expected outcomes
OUTLINE OUTLINE
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Blood Plasma: a valuable human resourceBlood Plasma: a valuable human resource
Medicinal products derived from human donations of blood and plasma play a critical role in health care
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Human Blood PlasmaHuman Blood Plasma
Complex mixture of (glyco)proteins
Therapeutic product (plasma for transfusion = fresh frozen plasma)
Pooled plasma = starting material for fractionation to medicinal products:
Albumin Blood Coagulation Factors (e.g. F VIII, FIX) Immunoglobulins (IV, IM) Serine proteases Fibrin sealants
Human Plasma Human Plasma
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WHO Essential Medicines List WHO Essential Medicines List
Human derived blood plasma products
– Plasma for Fractionation• Blood Coagulation Factors: FVIII, PCC• Human Normal Immunoglobulin (IV and IM)• Anti-D immunoglobulin• Anti-tetanus immunoglobulin
Blood-derived medicinal products for the treatment of
haemophilia and immune diseases are included in the WHO Model List of Essential Medicines
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What is the global situation ?What is the global situation ?
The global need for blood plasma products exceeds by far available supply
Plasma for fractionation available in industrialized countries to cover their needs
Alternatives to plasma products are not sufficiently available, or even not existent
hemophilia: recombinant products are expensive; gene therapy still experimental
normal immunoglobulin should cover the wide range of antigens (e.g. pathogens) prevailing in a population;
specific immunoglobulins can be sourced only in immunized populations
Availability of blood plasma products Availability of blood plasma products
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Plasma Safety in highly regulated countriesPlasma Safety in highly regulated countries
Commitment of health politicians, strong regulation, reinforcement and continuous surveillance by authorities
Commitment of blood services and plasma fractionators
GMP implementation in manufacture of all blood plasma derived products
No documented virus transmission by plasma products licensed within this regulatory framework > 10 years
Blood plasma products needs covered
Plasma safety and availability: highly regulated countries
Plasma safety and availability: highly regulated countries
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Plasma « unused » for fractionationPlasma « unused » for fractionation
Quality criteria for plasma for fractionation not met GMP has not been a natural background for blood transfusion Sensitivity of blood transfusion services to independent
regulatory control Need to strengthen experience & regulation of plasma and
plasma products Lack of government awareness: rationale for regulation Lack of technical capacity of regulatory authorities
Plasma «unused» for fractionation:countries with poor or limited regulations
Plasma «unused» for fractionation:countries with poor or limited regulations
5.8 million liters not recovered in developing countries (Burnouf, 2007)
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Achilles Project: Rationale Achilles Project: Rationale
Blood plasma products in the WHO Essential Medicines List but no access to these products by developing countries because of:
1. Poor quality and safety of plasma (destroyed)
2. Need for introduction of blood products regulations
3. The Achilles project considers upgrading of plasma quality as the driving force for implementation of a safe blood program.
4. The project includes elements of quality, safety and economical benefits.
5. May attract more efficiently the attention of the authorities
Achilles Project: Rationale Achilles Project: Rationale
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Conclusion: Conclusion:
Use of local plasma to improve supply of plasma products in developing countries, a legitimate option
Compliance with GMP, a key issue for successful PCF
Build-up technical expertise of local NRA and plasma supplier is a need
Common GMP standards, a basis for mutual recognition of quality standards and inspections results between NRA's
Independent regulatory systems for blood products regulation need to be established or strengthened in developing countries
Adoption of a Regional/International GMP standard facilitates regional collaboration between NRAs and implementation of PCF
Achilles Project: Rationale
Achilles Project: Rationale
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GMP implementation in Blood/Plasma Establishments: a key element to
Quality and safety of plasma for fractionationPlasma contract fractionation programs
Supporting access to blood plasma products
Good Manufacturing Practices (GMP): an essential tool for improvement of safety
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TRACEABILITYTRACEABILITY FROM DONOR TO PATIENTFROM DONOR TO PATIENT
TRACEABILITYTRACEABILITY FROM DONOR TO PATIENTFROM DONOR TO PATIENT
COMPONENTS PREPARATION
DONATIONINFORMATION
FRACTIONATIONVIRAL INACTIVATION
TREATMENT
GMPLOOK BACK SYSTEM
Blood/Plasma donation
Plasma for Fractionation
Blood Components
Plasma-Derived Medicinal Product
PatientsPatients
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WHO and Plasma for FractionationWHO and Plasma for Fractionation
Quality of blood/ plasma is dependent on collection, preparation, testing , storage and transport
Quality of plasma for fractionation influences the range, quantity, quality, and safety of plasma derivatives
WHO Recommendations for the Production,
Control and Regulation of Human Plasma for
Fractionation
(adopted in November 2005)
www.who.int/medicines www.who.int/bloodproducts
Plasma for Fractionation* a biological product inherent variability
Plasma for Fractionation* a biological product inherent variability
* WHO Technical Report Series 941, Annex 4: 56th WHO Expert Committee on Biological Standardization, 24-28 October 2005.
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Assuring Blood/Plasma Safety: “Layers of Safety”
1. Donor selection criteria (epidemiological data)
2. Deferral procedures: national registries to avoid use of collections from previously unsuitable donors
3. Laboratory testing for infectious disease markers: selection of kits and validation
4. Implementation of GMPs in blood/plasma collection establishments
Assuring Blood/Plasma Safety: “Layers of Safety”
Assuring Blood/Plasma Safety: “Layers of Safety”
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Plasma Contract Fractionation Programs(Need for GMP implementation)
Plasma Contract Fractionation Programs(Need for GMP implementation)
GM
PL
ice
ns
ing GM
PL
ice
ns
ing
Quality Assurance Program
across countries
PLASMASUPPLIER FRACTIONATOR
Nat.Reg.Authority
Nat.Reg.Authority
GMP- common principles
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Pathogen ThreatsPathogen Threats
24 Aug 07
Over 2.0 billion airline passengers are traveling each year.The battle against infections and the struggle for blood safety are closely interrelated !Infections are a global problem necessitating global collaboration!
ource:
Europe 1985-1992250,000
Australia 199080,000
Australia 2005/200665,707
Spain 2005>1 million
Legal 640,000Canada 2001216,975
USAUp 1989:2,459,000
90s: legal 7,036,000
Up 2005: legal 7,486,643
Undocumented2000: 5,6 million2006: 8,9 million
Japan 1990 150,000
Japan 1994 250,000
Migration Flows from Latin America Chagas disease
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Pathogen ThreatsPathogen Threats
Impact of migrations: health safety/security
Standardization of in vitro biological diagnostic technologies
Convergence of regulatory policies
Track and monitor blood safety
Need to strengthen blood products regulations worldwide to ensure availability of safe blood and blood products in the face of known and emerging threats, including emerging infectious diseases
Pathogen Threats Pathogen Threats
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Increase availability of safe blood derived products by:
Supporting implementation of national validated quality and safety standards for blood establishments
Using expertise and experience from developed countries
WHO Guidelines for good manufacturing practices (GMP) in blood establishments are being developed to support implementation.
WHO “Achilles” project: Expected Outcomes
WHO “Achilles” project: Expected Outcomes
WHO “Achilles” project: Project Goals
WHO “Achilles” project: Project Goals
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WHO “Achilles” projectAction Plan (demonstration project)
WHO “Achilles” projectAction Plan (demonstration project)
Development of comprehensive GMP guidelines to support training and inspection activities: GMP Guidelines for Blood Establishments (high priority project, ECBS 2009)
Upgrading quality assurance systems and regulatory expertise initially in 2 pilot countries.
Development of specific and measurable health care outcomes to monitor success and progress (e.g. plasma available, reduction of infectious disease markers in blood donors, decrease of GMP failures, economic benefit)
WHO “Achilles” projectAction Plan (demonstration project)
WHO “Achilles” projectAction Plan (demonstration project)
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Sustainable and affordable blood plasma derived essential medicines
Optimal use and benefit from donated blood plasma
Increased quality and safety of all blood products in blood establishments
Substantial contribution to public health programs
International agreed standards for blood establishments
Potential application of QA and GMP principles to other medical disciplines
Involvement of developing countries in international BT activities
WHO “Achilles” project: Expected Outcomes
WHO “Achilles” project: Expected Outcomes
WHO “Achilles” project: Expected Outcomes
WHO “Achilles” project: Expected Outcomes
HSS/EMP/BPB: Teheran, Oct 0822 |
International Conference of Drug Regulatory International Conference of Drug Regulatory AuthoritiesAuthorities (ICDRA): Recommendations, Bern 2008
Recognizing the need worldwide for blood products regulation to ensure availability of safe blood and blood products in the face of known and emerging threats, including emerging infectious diseases, WHO should:
» Take steps to further develop and strengthen national/regional blood regulatory authorities and to promote cooperation
» Provide harmonized "assessment criteria for blood regulatory systems" (BRN): convene a consultation of NRAs to review Draft assessment tool
» Prioritize development of Guidelines on GMP for Blood Establishments » Promote introduction of WHO recommended plasma standards by NRAs
Emerging Diseases: regulating blood products
(ICDRA: Recommendations, Bern 08)
Emerging Diseases: regulating blood products
(ICDRA: Recommendations, Bern 08)
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www.who.int/bloodproductswww.who.int/biologicalswww.who.int/medicines
Web site addressesRelevant Web site addresses Relevant Web site addresses