Implication and Experience of AFSSAPS in the release of Poliomyelitis Vaccines

Transcription

1 Implication and Experience of AFSSAPS in the release of Poliomyelitis Vaccines 7 th WHO/UNICEF Consultation with OPV/IPV Manufacturers and RNAs S. MORGEAUX- CVV Unit DLC Lyon site

2 Inactivated Poliomyelitis Vaccines

3 European Batch Release Between 100 to 120 batches of single IPV vaccine More than 100 batches of combined IPV vaccines Testing Appearance Determination of D antigen content by ELISA method Technical Service Agreement for WHO

4 Collaborative studies EDQM Establishment of a 2 nd European Pharmacopoeia BRP batch for in vitro assay (Project Leader Published in PharmEuropa Bio 2003) Feasibility study to develop a common in vitro D antigen assay (Project Leader Published in PharmEuropa Bio 2005) WHO Replacement of the 2 nd International Reference Reagent ( ) Proficiency Testing Study EDQM In vitro Potency Assay (Scientific Adviser 2007)

5 Oral Poliomyelitis Vaccines

6 Batch Release Around 100 batches of trivalent OPV vaccine Between 60 to 100 batches of monovalent T1 OPV vaccine Testing Appearance Potency and thermal stability Technical Service Agreement for WHO

7 Collaborative studies EDQM Establishment of a 3 rd European Pharmacopoeia BRP batch (2001) WHO To Assess the suitability of the replacement of the International Standard (2004) Proficiency Testing Study EDQM Potency Assay (in progress 2008)

8 Monkey Neurovirulence Test

9 READING SLIDES CONTEXT AT AFSSAPS AFSSAPS expertise since year 2000: external expert authorized for slides reading Need to train and validate internal expert to maintain expertise

10 TRAINING OF NEW EXPERTS Background 3 scientists with no experience in neurology were trained Training plan: academic and technical First year (80hr) Academic training: knowledge on CNS Second year (50hr) Reading of monkeys slides in parallel with the qualified expert Third year (80hr) Qualification of new experts

11 ROUTINE TESTING European Batch Release Between 5 to 10 concentrated monovalent bulks Prerequisites for each expert Had established his own historic to qualify tests of reference vaccines taking into account the origin of monkeys Should maintain expertise based on examination of at least 3 monkeys slides (reference) for each set of slides submitted for release per year Should perform the calculation once a year WHO PTS : slides reading ( )

12 Transgenic Mice Neurovirulence Test

13 TRAINING OF NEW EXPERTS Afssaps strategy : An independent training from the manufacturer First training by NIBSC Next training at two manufacturer s sites 2 scientists with complementary competences to be trained 1 scientist involved in MNVT and OPV release 1 scientist in charge of the animal facility

14 TRAINING OF NEW EXPERTS Training plan: EDQM workshops at NIBSC + 3 days scoring specific training sessions meeting at manufacturer s site (J0 J6 J14 test observation) meeting at the other manufacturer s site (J6 test observation)

15 QUALIFICATION OF NEW EXPERTS EDQM workshop at NIBSC Qualification of the two experts by NIBSC for TgMNT scoring in parallel with their qualified scorer

16 RELEASE ACTIVITY IMPLEMENTATION : scoring sessions at manufacturer s site J0 J4/J5 for Type 1 J5/J6 for Type 3 and J14 Statistical analysis Checking of the control protocol and manufacturer s results

17 Poliovirus containment

18 French legislation towards Poliovirus handling Ministerial order and law L on MOT (2004) Importation, exportation, holding, transfer, purchase, transport of MOT -> require Afssaps authorization Poliovirus is considered as a MOT for which fraudulent use could be a danger to public health Decrees of application in process on : Competence of the applicant Content of the file submitted to Afssaps GLP requirements of the laboratories where MOT are handled (containment ) Inspection procedures Afssaps is actively involved in the legislation process

19 WHO global action plan for poliovirus containment: application at Afssaps Laboratories inventory Objective: reduction of the number of poliovirus facilities (<20 worldwide by the time of OPV cessation) France : 56 labs retain wild poliovirus infectious materials or potential infectious materials, including Afssaps Implementation of biosafety measures BSL3 facility for activity and storage Containment of wild poliovirus Personnel: immunized and trained QA system Risk assessment Working group on Biosafety: risk and consequences of inadvertent transmission of poliovirus from laboratory to the field risk and consequences of ill-intentioned actions

20 AFSSAPS S BSL3 FACILITY LYON SITE BSL3 lab 2 Double-entrances security doors 2 1 Material Double-entrances security doors Corridor Washing room Restricted access Double entrance security doors are self-closing and interlocking

21 AFSSAPS S BSL3 FACILITY LYON SITE Double doors autoclave in BSL3 lab Locked freezer in BSL-3 Lab

22 AFSSAPS S BSL3 FACILITY LYON SITE Protective laboratory clothes Certified biological safety cabinet class II Sealed decontamination

23 AFSSAPS S BSL3 STAFF LYON SITE 1 Head of the BSL3 and 2 authorized technicians Medical All persons entering the laboratory are fully immunized against polio Medical examination of all laboratory personnel working in biosafety level 3 is mandatory Training in: Hygiene and microbiology Basic principles of BSL-3/IPV Containment procedures Risk assessment

24 The staff OPV IPV 1 scientist (V. Pithon) 1 technician (N. Dehay) 1 scientist (J. Korimbocus) 2 technicians (C.Boulet) (P. Variot) Containment 1 scientist (S. Jorajuria) 2 technicians (I. Manniam) (N. Dehay) MNVT slides reading TgMNT 3 scientists (F.Garnier) (S. Jorajuria) (V. Pithon) 2 scientists (M. Pares) (V. Pithon)

25 Thank You!