International Standards for Biotechnology

Transcription

1 Bureau International des Poids et Mesures International Standards for Biotechnology Dr R I Wielgosz BIPM BIPM

2 International Compatibility of Measurement Standards The task of the BIPM is to ensure world-wide uniformity of measurements and their traceability to the International System of Units (SI). Intergovernmental Organization Headquarters with Laboratories Consultative Committees with experts from National Metrology Institutes International Comparisons of Standards and Measurement Capabilities Joint Committees with other Organizations BIPM

3 Measurement Standards not Normative Written Standards, but Global System of Comparisons CIPM-MRA Technical basis for: -Determination of the degree of equivalence of measurement standards -Mutual recognition of calibration and measurement certificates Bureau International des Poids et Mesures

4 qpcr International Comparison Results: CCQM-K86 CCQM P44 1st round - 250pg/ul C C Q M CCQM K61 : Unknown 0.02pg/ul B A W G DNA (pg/ul) Deviation (%) a 3b 4 5a 5b 5c 5d 6a 6b 7a 7b c 17a Lab Thailand KRISS-TM NIST LGC NIM NMIA IRMM VNIIM NMIJ Lab Report - BIPM Key Comparison Data Base (

5 strong interdependency between written and Measurement Standards BIPM

6 and some BIPM publications International Vocabulary of Metrology (VIM) JCGM 200:2008 SI Brochure Expression of uncertainty in measurement JCGM 100:2008 Terminology Definitions and realizations of SI units BIPM

7 From Physics and Engineering to Biotechnology Consultative Committees with experts from National Metrology Institutes (NMIs) BIPM Biostudy Initiative Joint Committee for Traceability in Laboratory Medicine (JCTLM) BIPM

8 From Physics and Engineering to Biotechnology The CIPM Consultative Committees CCAUV CCEM CCL CCM CCPR CCQM CCRI CCT CCTF CCU Consultative Committee for Acoustics, Ultrasound and Vibration Consultative Committee for Electricity and Magnetism Consultative Committee for Length Consultative Committee for Mass and Related Quantities Consultative Committee for Photometry and Radiometry Consultative Committee for Amount of Substance (Chemistry) Consultative Committee for Ionizing Radiation Consultative Committee for Thermometry Consultative Committee for Time and Frequency Consultative Committee for Units BIPM

9 CCQM Metrology in Chemistry (est. 1993) CCQM Working Groups Key Comparisons NMIA L. Mackay Organic Analysis NIST W. May Inorganic Analysis LGC M. Sargent Gas Analysis NPL M. Milton Electro-chemical Analysis SMU M. Mariassy Surface Analysis BAM W. Unger Bio-Analysis LGC H. Parkes 2 ad hoc WGs (KCRV, redefinition SI) 9

10 C C Q M B A W G CCQM-BAWG est Terms of Reference (i) To establish global comparability through bioanalytical reference measurement systems of the highest possible metrological order comprising: Traceability to the SI, where feasible, or to other internationally agreed units Reference methods CRMs Uncertainty estimates for the whole process To develop, improve and validate those systems through pilot studies prioritised in response to demands of endusers (eg. healthcare, food, pharmaceutical, forensic) and regulation (eg, ICH, FDA, EU IVD, OECD)

11 C C Q M B A W G Terms of Reference (ii) To establish comparability of NMIs and designated National Expert Laboratories through prioritised Key Comparisons To integrate BAWG activity with that of international stakeholders such as WHO, CODEX, JCTLM in order to harmonise bioanalytical reference measurement systems

12 C C Q M B A W G Study progress : CCQM K86 - Relative quantification of genomic DNA fragments extracted from a biological tissue (IRMM) CCQM P Quantification of DNA methylation (KRISS) CCQM P103 - Measurement of RNA transcripts CCQM P102 - Quantification of cells (in solution) with specific phenotypic characteristics (flow) (NIBSC/PTB/ NIST) CCQM P Peptide / protein quantification (NIST/LGC/PTB) CCQM P58.1 ctni ELISA measurement (NPL/NIST) CCQM-P123 Cell quantification on solid substrate (INRIM / NIST/ LGC) CCQM-P103.1 (LGC/NIST) Measurement of multiple RNA transcripts

13 Metrology for the Biosciences Study and Report Final Report Published March 2011

14 Study Objectives Determine the measurement services required to establish an International Measurement Infrastructure for Biosciences that: Are expected to be developed/delivered over the next 3-10 yr by NMIs and other measurement organisations Are required by industry and other stakeholders Determine the international comparisons that are required to demonstrate the equivalence of the measurement services Determine the R&D activities necessary for the development of higher metrological order measurement standards and methods

15 Review of Roadmaps & Strategies: Key Publications NIST draft report June 2009: Measurement Science and Measurement Standards to Support Innovation in Healthcare Euramet programme outline, Nov. 2008: European Metrology Research Programme UK National Measurement Office, May 2009: The National Measurement System Strategy ISO, Aug. 2009: Council Task Force on Biotechnology

16 Responses from 20 Measurement Institutes Worldwide : Application Areas No. of Institutes Diagnost. Pharma. Health Tech Forensics Indust. Food Environ. Others

17 Industrial Organisations Organisation Abbott Diagnostics, USA Biocon, India Dr Reddy s, India Lonza Biologics, UK European Biopharma Producer AGEPS, France BioRad, France Diagnostica Stago, France LFB, France Activity Diagnostics Bio-pharmaceuticals Bio-pharmaceuticals Bio-pharmaceuticals Bio-pharmaceuticals Bio-pharmaceuticals Diagnostics Diagnostics Bio-pharmaceuticals

18 Diagnostics Industry: Measurement Needs Global comparability very important ISO the way forward Higher order reference methods for proteins, especially those based on mass spectrometry Higher order reference materials, especially for troponin, hcg, hepatitis and HIV antibodies Reference measurement procedures for common immunoassays troponin a good starting point Characterisation of structural heterogeneity, especially glycans need to properly define the measurand

19 Bio-pharmaceutical Industry: Measurement Needs Well-characterised protein reference standards for comparable PTM measurements across analytical platforms Standards for water content of bio-pharma products Pure amino acid calibrators to underpin product characterisation Standards and best practice methods for glycan profiling Improved methods for tertiary structural measurements Improved MS methods for peptide mapping

20 Joint Committees Committees of the BIPM and other international organizations, created for particular tasks of common interest. JCTLM Joint Committee for Traceability in Laboratory Medicine. The goal of the JCTLM is to provide a worldwide platform to promote and give guidance on internationally recognized and accepted equivalence of measurements in laboratory medicine and traceability to appropriate measurement standards. JCGM Joint Committee for Guides in Metrology. BIPM, IEC, IFCC, ILAC, ISO, IUPAC, IUPAP, OIML The tasks of the JCGM are to maintain and promote the use of the Guide to the Expression of Uncertainty in Measurement (known as the GUM) and the International Vocabulary of Basic and General Terms in Metrology (known as the VIM). DCMAS Network Network on Metrology, Accreditation and Standardization for Developing Countries. BIPM

21 JOINT COMMITTEE for TRACEABILITY in LABORATORY MEDICINE (JCTLM) Declaration of co-operation establishing A framework for the international recognition of available higherorder reference materials, measurement procedures and reference measurement laboratories Bureau International des Poids et Mesures

22 ... the traceability of values assigned to calibrators and control materials must be assured through available reference measurement procedures and/or reference materials of a higher order... Annex 1 (3) 2nd para IVD Manufacturers have requested that NMIs develop internationally recognized reference methods and CRMs to meet this assist them in meeting this traceability requirement. Bureau International des Poids et Mesures

23 ISO 15194:2009 Normative referenced documents ISO 17511:2003, Metrological Traceability of values assigned to calibrators and control materials ISO 18153:2003, Metrological Traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials ISO Guide 31, Reference materials Contents of certificates and labels ISO Guide 34:2000, General requirements for the competence of reference material producers ISO Guide 35:2006, Reference Materials General and statistical principles for certification Guide to the expression of uncertainty in measurement (GUM) International Vocabulary of Metrology (VIM) ISO :1994, Accuracy (trueness and precision) of measurement methods and results ISO 31(all parts), Quantities and units Bureau International des Poids et Mesures

24 Bureau International des Poids et Mesures JCTLM Database: Search Engine

25 JCTLM Database: C-reactive Protein Bureau International des Poids et Mesures

26 JCTLM Database Status - April 2011 Reference materials Total number of entries is 247 among which 33 are in «List II», and 3 in «List III» Distribution of entries for higher order Reference Materials by Group of Analyte and Region of Origin Total number of entries : 247 April 2011 Asia North America Europe Blood Gases Blood Groupings Coagulation Factors Drugs Electrolytes Enzymes Metabolites and Substrates Microbial Serology Non-Electrolyte Metals Non-Peptide Hormones Nucleic Acids Proteins Vitamins and Micronutrients Number of entries

27 BIPM activities and International Standards for Biotechnology Relevant activities include Joint Committee Guides and Databases: JCGM and JCTLM CCQM Bio-analysis WG Comparisons BIPM Programme BIPM