TY - Generic T1 - Comment implémenter l'analyse de tendance Y1 - 2023 A1 - L. Tesolin A1 - J. Auquier KW - libération KW - tendance KW - vaccin JF - Webinar ARP Senegal PB - Sciensano CY - Sciensano, Brussels ER - TY - JOUR T1 - Development of a multiplex-based immunoassay for the characterization of diphtheria, tetanus and acellular pertussis antigens in human combined DTaP vaccines. JF - J Immunol Methods Y1 - 2023 A1 - Maxime Vermeulen A1 - Isabelle Feck A1 - Antoine Francotte A1 - Laura Hassall A1 - L. Tesolin A1 - Wim Van Molle A1 - Romain Pizzato A1 - Thierry Laurent A1 - Charline Hoebreck A1 - Paul Stickings A1 - Alexandre Dobly KW - Animals KW - Antibodies, Bacterial KW - Antigens KW - Diphtheria KW - Diphtheria-Tetanus-acellular Pertussis Vaccines KW - Diphtheria-Tetanus-Pertussis Vaccine KW - Humans KW - Hydrogen Peroxide KW - Immunization, Secondary KW - Immunoassay KW - Reproducibility of Results KW - Tetanus KW - Whooping Cough AB -

Routine batch quality testing before vaccine release, notably for potency evaluation, still relies on animal use for several animal and human vaccines. In this context, the VAC2VAC project is a public-private consortium of 22 partners funded by EU whose the main objective is to reduce the number of animal used for batch testing by developing immunoassays that could be implemented for routine potency assessment of vaccines. This paper focused on the development of a Luminex-based multiplex assay to monitor the consistency of antigen quantity and quality throughout the production process of DTaP vaccines from two human vaccine manufacturers. Indepth characterized monoclonal antibody pairs were used for development and optimization of the Luminex assay with non-adsorbed and adsorbed antigens and with complete vaccine formulations from both manufacturers. The multiplex assay demonstrated good specificity, reproducibility and absence of cross-reactivity. Analysis of over and underdosed formulations, heat and H2O2-degraded products as well as batch to batch consistency of vaccines from both manufacturers brought the proof of concept for a future application of the multiplex immunoassay as a useful tool in the frame of DTaP vaccine quality control.

VL - 517 M3 - 10.1016/j.jim.2023.113483 ER - TY - RPRT T1 - EU batch release procedure: Annual Report 2 - Batch Release of Vaccines Y1 - 2023 A1 - Geneviève Waeterloos A1 - J. Auquier A1 - C. Domicent A1 - L. Cuignet A1 - S. Clouet A1 - N. Desmet A1 - Morgane Florens A1 - F. Laurent A1 - F. Masquelier A1 - F Ribaucour A1 - L. Stradiot A1 - L. Tesolin A1 - Wim Van Molle KW - Vaccine - Quality control - Batch release - Procedure PB - Sciensano ER - TY - Generic T1 - l'analyse de tendance-concepts préliminaires Y1 - 2023 A1 - L. Tesolin A1 - N. Desmet KW - libération KW - tendance KW - vaccin JF - webinar ARP Senegal PB - Sciensano CY - Sciensano, Brussels ER - TY - RPRT T1 - OCABR: Respiratory Syncytial Virus (rDNA) Vaccine Y1 - 2023 A1 - L. Tesolin A1 - D. Garcia A1 - V. Oppling A1 - M. Bruysters A1 - D. Pullirsch A1 - L. Campitelli KW - EDQM KW - guideline KW - OCABR KW - RSV PB - EDQM CY - Strasbourg (F) ER - TY - Generic T1 - Phase 2 testing: where are we now? Y1 - 2023 A1 - M. Bruysters A1 - L. Tesolin A1 - J. Lange KW - bulk KW - phase 2 KW - vaccines JF - OMCL Annual Meeting EDQM 2023 PB - EDQM CY - Madrid, SPain ER - TY - JOUR T1 - Rational arguments for regulatory acceptance of consistency testing: benefits of non-animal testing over release testing of vaccines. JF - Expert Rev Vaccines Y1 - 2023 A1 - Marcel H N Hoefnagel A1 - Paul Stickings A1 - Dean Smith A1 - Carmen Jungbäck A1 - Wim Van Molle A1 - L. Tesolin AB -

INTRODUCTION: There are rational arguments to replace existing in vivo potency and safety assays for batch release testing of vaccines with more advanced non-animal techniques to measure critical quality attributes. However, introduction of in vitro alternatives to replace in vivo release assays of authorized vaccines is challenging.

AREAS COVERED: This report describes the hurdles encountered in substituting assays and ways to overcome these and provides arguments why more advanced alternatives are superior, not only as tool to monitor the quality of vaccines but also from a practical, economical and ethical point of view. The rational arguments provided for regulatory acceptance can support a strategy to replace/substitute any batch release test if an appropriate non-animal testing strategy is available.

EXPERT OPINION: For several vaccines, in vivo release assays have been replaced leading to an optimized control strategy. For other vaccines, new assays are being developed, that can expected to be introduced within 5-10 years. From a scientific, logistical and animal welfare perspective, it would be beneficial to substitute all existing in vivo batch release assays for vaccines. Given the challenges relating to development, validation and acceptance of new methods, and considering the relatively low prices of some legacy vaccines, this cannot be done without government incentives and supportive regulatory authorities from all regions.

VL - 22 CP - 1 M3 - 10.1080/14760584.2023.2198601 ER - TY - RPRT T1 - Report of WHO Drafting Group meeting to revise WHO Guidelines on procedures and data requirements for changes to approved vaccines Y1 - 2023 A1 - L. Tesolin A1 - H. Meyer A1 - D. Lei A1 - T. Jivapaisarnpong A1 - M. Welin A1 - A. Cheung PB - WHO CY - Geneva, switzerland ER - TY - Generic T1 - A roadmap for regulatory implementation of in vitro models for evaluation of vaccine efficacy Y1 - 2023 A1 - R. J. Vandebriel A1 - L. Tesolin A1 - K. Veenstra A1 - K. Huber KW - in vitro model KW - Regulatory KW - roadmap KW - Vaccine Efficacy PB - EVI CY - Niagara falls, Canada ER - TY - Generic T1 - Training on the assessment of quality part (M3) of the eCTD for the registration of vaccines for human use Y1 - 2023 A1 - Koen Brusselmans A1 - Wim Van Molle A1 - L. Tesolin KW - assessment KW - module 3 KW - vaccines JF - Training on The assessment of quality part (M3) of the eCTD for the registration of vaccines for human use PB - Sciensano CY - Brussels, Belgium ER - TY - Generic T1 - The vaccine Batch release procedure in Europe Y1 - 2023 A1 - L. Tesolin JF - Seminaire etudiants en pharmacie ULB PB - ULB CY - Brussels, Belgium ER - TY - Generic T1 - WHO Drafting Group meeting to revise WHO Guidelines on PAC- outcome of workshops Y1 - 2023 A1 - L. Tesolin KW - post-approval changes KW - vaccines KW - WHO JF - WHO Drafting Group meeting to revise WHO Guidelines on procedures and data requirements for changes to approved vaccines PB - WHO CY - Frankfurt, Germany ER - TY - Generic T1 - Auditors experience with remote audits ‘Preparatory phase’ Y1 - 2022 A1 - Geneviève Waeterloos A1 - L. Tesolin A1 - Wim Van Molle KW - mutual joint audit KW - mutual recognition KW - OMCL JF - OMCL annual meeting 2022 PB - GeON, EDQM, strasbourg CY - EDQM, strasbourg ER - TY - Generic T1 - The batch release procedure in Europe Y1 - 2022 A1 - L. Tesolin KW - batch release KW - Europe KW - OMCL KW - vaccine JF - Seminaire etudiants en pharmacie ULB PB - ULB CY - Brussels, Belgium ER - TY - Generic T1 - The change in testing strategy for purity test on monovalent bulk of recombinant protein vaccine, Q&A Y1 - 2022 A1 - L. Tesolin A1 - M. Bruysters KW - control strategy KW - OMCL KW - recombinant protein KW - vaccine JF - OMCL annual meeting 2022 PB - EDQM CY - EDQM, strasbourg ER - TY - RPRT T1 - Concept paper on the change in testing strategy for purity test on monovalent bulk of recombinant protein vaccine Y1 - 2022 A1 - L. Tesolin A1 - M. Bruysters KW - control strategy KW - OMCL KW - recombinant protein KW - vaccine PB - EDQM CY - Strasbourg, France ER - TY - JOUR T1 - The consistency approach for the substitution of in vivo testing for the quality control of established vaccines: practical considerations and progressive vision JF - Open Research Europe Y1 - 2022 A1 - L. Tesolin A1 - J.-F. Dierick A1 - Wim Van Molle KW - human vaccines KW - in vitro testing KW - in vivo testing KW - Regulatory M3 - https://doi.org/10.12688/openreseurope.15077.2 ER - TY - Generic T1 - Manufacture and control of vaccine adjuvants from OMCL perspective Y1 - 2022 A1 - L. Tesolin KW - Adjuvants KW - manufacture KW - OMCL KW - vaccine JF - Seminaire ULB Pharmacien d'industrie PB - ULB CY - ULB pharmacie ER - TY - RPRT T1 - OCABR guideline for inactivated COVID-19 vaccines Y1 - 2022 A1 - D. Pullirsch A1 - L. Campitelli A1 - M. Bruysters A1 - L. Tesolin A1 - V. Oppling A1 - D. Garcia KW - COVID-19 KW - EDQM KW - inactivated vaccine KW - OCABR PB - EDQM CY - EDQM, strasbourg ER - TY - Generic T1 - Training on biological methods (Immunology) Y1 - 2022 A1 - J. Auquier A1 - C. Domicent A1 - F. Masquelier A1 - S. Clouet A1 - L. Tesolin KW - EDQM KW - Immunological methods KW - training PB - Sciensano CY - Sciensano, Bruxelles ER - TY - Generic T1 - The vaccine Batch release procedure in Europe Y1 - 2022 A1 - L. Tesolin KW - batch release KW - Europe KW - OMCL KW - vaccine JF - Seminaire ULB Pharmacien d'industrie PB - ULB CY - ULB pharmacie ER - TY - Generic T1 - "WHO Workshop on Implementation of Guidelines for procedures and data requirements for changes to approved vaccines" Y1 - 2022 A1 - D. Lei A1 - H. Meyer A1 - T. Jivapaisarnpong A1 - L. Tesolin JF - "WHO Workshop on Implementation of Guidelines for procedures and data requirements for changes to approved vaccines" PB - WHO CY - Mascate, Oman sultanate ER - TY - Generic T1 - Workshop on implementation of single dilution assay for in vivo testing Y1 - 2022 A1 - F Ribaucour A1 - Morgane Florens A1 - L. Tesolin KW - in vivo KW - single dilution assay KW - vaccine JF - Workshop on implementation of single dilution assay for in vivo testing PB - Sciensano CY - Brussels, Belgium ER - TY - Generic T1 - The batch release procedure in Europe ; Bacterial and polysaccharide vaccines Y1 - 2021 A1 - L. Tesolin JF - ULB dept Pharmacy ER - TY - Generic T1 - The batch release procedure in Europe; manufacture and control of vaccine adjuvants; bacterial and polysaccharide vaccines Y1 - 2021 A1 - L. Tesolin JF - ULB dept Pharmacy ER - TY - Generic T1 - Evaluation of OCBAR testing of recombinant vaccine at bulk monovalent stage Y1 - 2021 A1 - L. Tesolin JF - OMCL annual meeting ER - TY - RPRT T1 - Evaluation of the quality, safety and efficacy of RNA-based prophylactic vaccines for infectious diseases: regulatory considerations Y1 - 2021 A1 - L. Tesolin A1 - Wim Van Molle A1 - Koen Brusselmans ER - TY - RPRT T1 - Guideline for Pandemic COVID-19 Vaccine (mRNA) Y1 - 2021 A1 - L. Tesolin KW - EDQM KW - mRNA KW - OCABR KW - vaccine PB - EDQM CY - EDQM, strasbourg ER - TY - RPRT T1 - Guideline for Pandemic COVID-19 Vaccine (Non-replicating Adenovirus-vectored vaccine) Y1 - 2021 A1 - L. Tesolin PB - EDQM CY - EDQM, strasbourg ER - TY - RPRT T1 - Guideline for Pandemic COVID-19 Vaccine (Recombinant Spike Protein) Y1 - 2021 A1 - L. Tesolin KW - COVID-19 KW - OCABR KW - vaccine PB - EDQM CY - EDQM, strasbourg ER - TY - Generic T1 - How to implement trend analysis Y1 - 2021 A1 - L. Tesolin A1 - Geneviève Waeterloos A1 - L. Stradiot A1 - F Ribaucour A1 - J. Auquier A1 - L. Cuignet JF - Training Saudi Food and Drug Authority ER - TY - Generic T1 - Libération des lots de vaccins Y1 - 2021 A1 - L. Tesolin JF - Training Senegal Agency ER - TY - Generic T1 - Panel discussion official forum Taiwan FDA to share/discuss about COVID-19 vaccine testing, medicines quality issues, and batch release procedures Y1 - 2021 A1 - L. Tesolin KW - batch release KW - COVID-19 vaccine KW - medicines quality issues KW - TESTING JF - Taiwan FDA to share/discuss about COVID-19 vaccine testing, medicines quality issues, and batch release procedures PB - Taiwan FDA CY - Taiwan ER - TY - Generic T1 - Roadmap from the classical control strategy of vaccines to the consistency testing based control strategy Y1 - 2021 A1 - L. Tesolin JF - VAC2VAC Workshop 24 June 2021 ER - TY - Generic T1 - RSV vaccine GSK : OCABR testing Y1 - 2021 A1 - L. Tesolin KW - OCABR KW - RSV KW - TESTING JF - EDQM OCABR drafting group PB - EDQM CY - EDQM, Strasbourg ER - TY - Generic T1 - Biological reference standards for multivalent vaccines: qualification strategies and challenges from a national control lab perspective Y1 - 2020 A1 - L. Tesolin KW - in vivo KW - OMCL KW - reference qualification KW - reference vaccine JF - CASS Bioassays 2020, Gaithersburg PA, USA PB - Sciensano CY - Gaithersburg, PA, USA ER - TY - RPRT T1 - Concept paper : rationale for deletion of the O-acetyl test on meningoccocal vaccines guidelines Y1 - 2020 A1 - L. Tesolin A1 - Christina von Hunolstein ER - TY - Generic T1 - Establishment of single dilution assays for animal based potency determinations Y1 - 2020 A1 - Geneviève Waeterloos A1 - L. Tesolin A1 - F Ribaucour A1 - Laurence Delbrassinne JF - WHO Webinar: Establishment of a single dilution potency assay ER - TY - Generic T1 - Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mindset of the manufacturer. Y1 - 2019 A1 - Wim Van Molle ED - L. Tesolin ED - Geneviève Waeterloos AB -

According to the European Directives 2001/83/EC and 2004/27/EC, EU Member States may require to test batches of immunological medicinal products or medicinal products derived from human plasma by an Official Medicines Control Laboratory (OMCL) before these can be marketed. A Batch Release Certificate is issued when the results are satisfactory. This is known as "Official Control Authority Batch Release" (OCABR) and consists of analytical controls and document review which are additional to the routine release testing that must be carried out by the manufacturer for each single batch. The Directives require Member States to recognize OCABR carried out by other Member States. This means that once a batch is released by the competent authority of one Member State, OCABR is valid for all other Member States, which is also known as mutual recognition.

Although the process of batch release in Europe is straightforward and clearly laid down in directives, it is sometimes a lengthy process. Sometimes more than one year should be taken into account between the intention of putting a vaccine on the market and the first available commercial batch. Since OCABR in EU is obligatory, it is the company’s responsibility to choose an OMCL belonging to the OMCL network. This choice, which is free, should be made before filing of the MA application. The initial process involves the transfer of the analytical methods for those tests that will be performed by the OMCL. Regarding the set of the tests to be performed by the OMCL, this is finally decided by EDQM and depends whether or not an OCABR guideline for the type of product in question is already in force. For the method transfer, many aspects should be taken into account such as for instance OMCL equipment availability, structural differences of equipment (between manufacturer and OMCL), shipment of samples and reagents,…. Assay variability and possible changes in analytical methods and specifications during the registration procedure should also be closely monitored.  The OMCLs also operate under a quality assurance system according to ISO17025 norm.

Once the method validation has been successfully completed and the company has obtained its MA, commercial batches can be put on the market. The OMCL release testing is a process that normally takes up to 60 calendar days. This release procedure, as mentioned above, involves one or several tests on final lot and sometimes on bulks and intermediates, as well as a critical protocol review of the manufacturer’s data. After testing and protocol review, the OMCL will issue a certificate of compliance, or in case of unsatisfactory test results, a certificate of non-compliance. The issuing of a non-compliance certificate is a rare event under normal circumstances and involves a thorough investigation from the side of the OMCL.

Finally, it should not be forgotten that, even when the method transfer has been completed and batch release is being performed on a routine basis, strict follow-up and close interactions between manufacturer and OMCL remain of utmost importance. The OMCL performing OCABR should always be notified of all relevant approved variations that have an impact on product specifications or on relevant batch record data (which are usually supplied in section 3 of the protocol). Important modifications of the manufacturing and testing procedures, changes in reagents and standards, and technical problems (both manufacturer and OMCL) should be shared as soon as possible in order to guarantee a continuous batch release and to prevent potential out-of-stock situations.

JF - EDQM & European Pharmacopoeia: State-of-the-Art Science for Tomorrow’s Medicines CP - EDQM ER - TY - Generic T1 - O-acetyl content testing in meningoccocal vaccine from an OMCL perspective Y1 - 2019 A1 - L. Tesolin A1 - Wim Van Molle JF - OMCL annual meeting ER - TY - Generic T1 - Use of non compendial reference standard for multi-valent vaccines Y1 - 2019 A1 - L. Tesolin A1 - Silvana Bellini JF - 13th international symposium on pharmaceutical reference standard, EDQM , Strasbourg (France) ER - TY - Generic T1 - Determination of Hib-TT Molecular Size Distribution: case study Y1 - 2017 A1 - L. Tesolin A1 - Christina von Hunolstein JF - WHO 1st NCLs Annual Meeting, India CP - WHO ER - TY - Generic T1 - HEXACIMA/HEXYON/HEXAXIM trade mark: OOS Hib PRP , investigation update and final outcome Y1 - 2017 A1 - L. Tesolin A1 - Valérian Bunel JF - OMCL annual meeting ER - TY - RPRT T1 - Quality Control of Polysaccharide Vaccines by the Belgian National Control Lab (OMCL) in the European Batch Release Framework : Activity Report 2016 Y1 - 2017 A1 - L. Tesolin A1 - Wim Van Molle KW - Vaccine conformity PB - Scientific Institute of Public Health CY - Brussels, Belgium SN - D/2017/2505/44 ER - TY - Generic T1 - Ensuring batch continuity of non-compendial reference & standard materials from biological origin Y1 - 2016 A1 - L. Tesolin A1 - C. Domicent A1 - M. Lejeune KW - meeting KW - ORIGIN KW - STANDARD JF - OMCL Annual Meeting 2016 PB - NA CY - NA CP - European Directorate for the Quality of Medicines & HealthCare (EDQM),Council of Europe U1 - 5761 U2 - 23/05/2016 - 27/05/2016 ER - TY - Generic T1 - Handling and use of non-compendial reference standards in the OMCL network Y1 - 2016 A1 - L. Tesolin KW - meeting KW - Reference Standards KW - STANDARD KW - standards KW - use JF - OMCL Annual Meeting 2016 PB - NA CY - NA CP - European Directorate for the Quality of Medicines & HealthCare (EDQM),Council of Europe U1 - 5762 U2 - 23/05/2016 - 27/05/2016 ER - TY - Generic T1 - Le controle de qualité des vaccins et produits dérivés du sang Y1 - 2016 A1 - L. Tesolin ED - ULB KW - de KW - EN KW - ET KW - LE KW - microbiologie KW - qualité KW - vaccin U1 - 5763 ER - TY - Generic T1 - Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mind-set of the manufacturer. Y1 - 2015 A1 - Wim Van Molle A1 - L. Tesolin A1 - Koen Brusselmans A1 - Geneviève Waeterloos KW - a KW - abstract KW - approach KW - approaches KW - batch release KW - challenge KW - CHALLENGES KW - conference KW - Countries KW - developing KW - Developing Countries KW - Europe KW - method KW - ON KW - vaccine KW - vaccines KW - WHO AB -

According to the European Directives 2001/83/EC and 2004/27/EC, EU Member States may require to test batches of immunological medicinal products or medicinal products derived from human blood or plasma by an Official Medicines Control Laboratory (OMCL) before these can be marketed. The competent authorities issue a Batch Release Certificate when the results are satisfactory. This is known as "Official Control Authority Batch Release" (OCABR) and consists of analytical controls and document review which are additional to the routine release testing that must be carried out by the manufacturer for each single batch. The Directives require Member States to recognize Official Control Authority Batch Release carried out by other Member States. This means that once a batch is released by the competent authority of one Member State, Official Control Authority Batch Release is valid for all other Member States, which is also known as mutual recognition.

Although the process of batch release in Europe is straightforward and clearly laid down in directives, it is sometimes a lengthy process. More than one year should sometimes be taken into account between the intention of putting a vaccine on the market and the first available commercial batch, aside from the development of the product and the Marketing Authorization (MA) process. Since OCABR in EU is obligatory for vaccines (and blood/plasma-derived medicinal products), it is the company’s responsibility to choose an OMCL belonging to the OMCL network. This choice, which is free, should be made before filing of the MA application. The initial process involves the transfer of the analytical methods for those tests that will be performed by the OMCL. Regarding the set of the tests to be performed by the OMCL, this can be proposed by the manufacturer but is finally decided by EDQM and depends whether or not an OCABR guideline for the type of vaccine in question is already in force. For the method transfer, many aspects should be taken into account such as OMCL equipment availability, structural differences of equipment (between manufacturer and OMCL), providing of samples and reagents, only to mention some of them. Assay variability and possible changes in analytical methods and specifications during the registration procedure should also be closely monitored. The full method transfer and validation process from start to finish can take up to 2 years, especially for complex and/or multivalent vaccines. The OMCLs also operate under a quality assurance system according to ISO17025 norm. At all times and stages, good communication between company and OMCL is imperative.

Once the method validation has been successfully completed and the company has obtained its MA, first commercial batches can be put on the market. The OMCL release testing is a process that normally takes up to 60 calendar days. This release procedure, as mentioned above, involves one or several tests on final lot and sometimes on bulks and intermediates, as well as a critical protocol review of the manufacturer’s data (including release test results as performed by the manufacturer). After testing and protocol review, the OMCL will issue a certificate of compliance, or in case of unsatisfactory test results, a certificate of non-compliance. The issuing of a non-compliance certificate is a rare event under normal circumstances and involves a thorough investigation from the side of the OMCL.

Finally, it should not be forgotten that, even when the method transfer has been completed and batch release is being performed on a routine basis, strict follow-up and close interactions between manufacturer and OMCL remain of utmost importance. The OMCL performing OCABR should always be notified of all relevant approved variations that have an impact on product specifications or on relevant batch record data (which are usually supplied in section 3 of the protocol). Important modifications of the manufacturing and testing procedures, changes in reagents and standards, and technical problems (both manufacturer and OMCL) should be shared as soon as possible in order to guarantee a continuous batch release and to prevent potential out-of-stock situations.

JF - PDA Europe Conference Vaccines. Featuring WHO on Challenges in Vaccines Supply to Developing Countries PB - PDA Europe CY - Berlin, Germany CP - PDA Europe U1 - 5244 U2 - 30/11/2015-2/12/2015 ER - TY - Generic T1 - Batch release procedure in Europe Y1 - 2015 A1 - L. Tesolin ED - WIV-ISP KW - batch release KW - blood KW - Control KW - Europe KW - PRODUCTS KW - Quality KW - Quality Control KW - vaccine KW - vaccines JF - Quality control and batch release of vaccines and blood products in Europe CP - WIV-ISP U1 - 38888 U2 - 24/03/2015 ER - TY - Generic T1 - Brief update on Malaria vaccine art 58 OCABR guideline Y1 - 2015 A1 - L. Tesolin KW - Malaria KW - meeting KW - ON KW - vaccine JF - Annual OMCL meeting PB - NA CY - NA CP - EDQM U1 - 5100 U2 - 1-05/06/2015 ER - TY - Generic T1 - Formation des autorités tunisiennes dans le cadre du renforcement des capacités en matière de l'activité d'octroi des visas des vaccins, sérums et produits biologiques Y1 - 2015 A1 - M Janssen A1 - L. Tesolin ED - NRA Tunesia KW - de KW - EN KW - ET KW - LE KW - ON KW - training KW - vaccin KW - WHO U1 - 5757 ER - TY - Generic T1 - Hexaxim/Hexacima/Hexyon: polysaccharide content results: OOS Y1 - 2015 A1 - L. Tesolin KW - meeting KW - result KW - results JF - Annual OMCL meeting PB - NA CY - NA CP - EDQM U1 - 5099 U2 - 1-5/06/2015 ER - TY - RPRT T1 - Quality Control of polysaccharide Vaccines by the Belgian National Control Lab (OMCL) in the European Batch Release Framework : Activity Report 2014 Y1 - 2015 A1 - L. Tesolin A1 - Wim Van Molle KW - Vaccine conformity PB - Scientific Institute Public Health CY - Brussels, Belgium SN - D/2015/2505/82 ER - TY - Generic T1 - Vaccine identity testing at National Control Lab Y1 - 2015 A1 - L. Tesolin KW - at KW - Control KW - meeting KW - national KW - TESTING KW - vaccine JF - Annual OMCL meeting PB - NA CY - NA CP - EDQM U1 - 5101 U2 - 1-5/06/2015 ER - TY - Generic T1 - Les vaccins : contrôles approfondis Y1 - 2014 A1 - Alexandre Dobly A1 - Koen Brusselmans A1 - L. Tesolin A1 - Geneviève Waeterloos KW - Belgique KW - ce KW - de KW - EN KW - ET KW - LE KW - médicament KW - PAR KW - qualité KW - santé KW - santé publique KW - Service KW - Type KW - vaccin AB - Contrairement aux autres médicaments, les vaccins sont contrôlés lot par lot indépendamment des producteurs. Ces contrôles sont obligatoires avant la libération de ces types de produits. Un fabricant doit avoir démontré l'efficacité, la sécurité et la qualité de la substance. Ensuite, il soumet chaque lot produit à l'autorité compétente pour contrôle. En Belgique, ces tâches sont effectuées par le service de Standardisation Biologique de l'Institut Scientifique de Santé Publique (WIV-ISP). JF - Vaxinfo VL - 69 U1 - 36900 ER - TY - RPRT T1 - Quality Control of Polysaccharide Vaccines by the Belgian National Control Lab (OMCL) in the European Batch Release Framework : Activity Report 2013 Y1 - 2014 A1 - L. Tesolin A1 - Wim Van Molle KW - Vaccine conformity PB - Scientific Institute of Public Health CY - Brussels, Belgium SN - D/2014/2505/42 ER - TY - Generic T1 - Veiligheid vaccins - Verregaande controle Y1 - 2014 A1 - Alexandre Dobly A1 - Koen Brusselmans A1 - L. Tesolin A1 - Geneviève Waeterloos KW - AAN KW - België KW - de KW - EN KW - kwaliteit KW - vaccin AB - Anders dan gewone medicamenten worden vaccins lot per lot gecontroleerd voor ze op de markt worden gebracht en dit onafhankelijk van de producent. De fabrikant moet de werkzaamheid, de veiligheid en de kwaliteit van het product aantonen. Vervolgens moet elk lot ter controle voorgelegd worden aan een onafhankelijk laboratorium hiertoe aangeduid door de overheid. In België gebeurt die controle door de dienst Biologische Standaardisatie van het Wetenschappelijk Instituut Volksgezondheid (WIV-ISP). JF - Vaxinfo VL - 69 U1 - 233 ER - TY - RPRT T1 - Quality control of polysaccharide vaccines by the Belgian National Control Lab (OMCL) in the European batch release framework: activity report 2012. Y1 - 2013 A1 - L. Tesolin A1 - Wim Van Molle KW - 2012 KW - Activity KW - batch release KW - Belgian KW - Control KW - European KW - national KW - Quality KW - Quality Control KW - report KW - vaccine KW - vaccines PB - Scientific Institute of Public Health (WIV-ISP) CY - Brussels, Belgium SN - D/2013/2505/36 U1 - 38887 ER - TY - Generic T1 - Regulatory issues regarding manufacture and control of vaccine adjuvants. The EU situation. Y1 - 2013 A1 - Wim Van Molle A1 - Koen Brusselmans A1 - L. Tesolin A1 - Geneviève Waeterloos KW - a KW - Activity KW - additional KW - ALL KW - Aluminium KW - an KW - Antioxidant KW - Antioxidants KW - application KW - AS KW - assessment KW - at KW - batch release KW - Belgian KW - Change KW - Clinical KW - clinical trial KW - Clinical trials KW - Combination KW - Components KW - Control KW - developing KW - Development KW - distribution KW - EU KW - European KW - future KW - Group KW - Guidelines KW - health KW - Hepatitis KW - Hepatitis B KW - Human KW - immune response KW - Impact KW - INFORMATION KW - Institute KW - IS KW - IT KW - Laboratories KW - LEVEL KW - marketing KW - means KW - mechanism KW - medicinal product KW - ON KW - organization KW - physical KW - present KW - PRESENTATION KW - protection KW - public KW - public health KW - Public-health KW - Quality KW - Receptor KW - Regulatory KW - Requirements KW - response KW - Responses KW - situation KW - specific KW - Stimulation KW - study KW - TESTING KW - Type KW - uptake KW - use KW - vaccine KW - vaccines KW - VIRUS KW - WHO KW - world KW - World Health KW - World Health Organization KW - World-health-organization AB -

Adjuvants are a specific group of vaccine/medicinal product compounds, since they are not classified as active substance but have more than just a stabilising activity. According to the EMA guideline EMEA/CHMP/QWP/396951/2006 (Guideline on excipients in the dossier for marketing authorization of a medicinal product), adjuvants, being no active substance, are categorised as excipients like antioxidants, preservatives, stabilisers, and many other. In the EMA guideline EMEA/CHMP/VEG/134716/2004 (Guideline on adjuvants in vaccines for human use) adjuvants are described as components that potentiate the immune responses to an antigen and/or modulate it towards the desired immune responses. Adjuvants can be classified according to their source, mechanism of action, or physical or chemical properties.

The EMA guideline on adjuvants further clarifies that the major means by which adjuvants may exert their activities are presentation of the antigen, antigen/adjuvant uptake, distribution, immune potentiation/modulation and/or protection of the antigen from degradation and elimination.

A manufacturer has to adhere to strict rules and guidelines regarding the manufacture and use of adjuvants. The same EMA guideline on adjuvants describes all the quality requirements, where the adjuvant should fulfil to. Depending on the type of adjuvant, additional guidelines are in force and should be followed. Non clinical testing with the adjuvant alone and in combination with the antigen should be thoroughly studied and documented. Finally, regarding clinical studies, the inclusion of an adjuvant in a vaccine must always be justified. The required clinical trials depend on whether it is a new adjuvant in a new vaccine, or rather a change to an already licensed vaccine.

Adjuvant type specific monographs described in the European Pharmacopoeia should also be followed by the manufacturer (e.g. Aluminium hydroxide and Aluminium phosphate). At the FDA, also guidelines on adjuvants are present and at the level of the World Health Organization (WHO), a guideline is under development.

All the above mentioned guidelines and monographs are also in force during the assessment of the marketing authorization application submitted by the applicant and should be taken into account by the regulatory assessors.

At the level of batch control and release by official medicinal control laboratories (OMCL's), the testing on adjuvants is very limited and for most vaccines not performed. At the Belgian Scientific institute of public health, MPL content is determined for batch release of a human papilloma virus vaccine and a hepatitis B vaccine. Testing by OMCL's on other adjuvants for other vaccines can be performed for information only.

Manufacturer's are continuously developing new complex vaccines with new complex adjuvants. Some of these adjuvants have strong immunological properties like receptor stimulation. In the near future, it might become necessary to create more detailed guidelines on the manufacture and control of these adjuvants and it might also be found necessary that OMCL's perform more testing on (new) adjuvants to better control the quality of vaccines.

JF - Modern Vaccines/adjuvants Formulation: Impact On Future Development PB - Meeting Management CY - Lausanne, Switserland CP - Herriot,J., Vanden Bossche,G. U1 - 39023 U2 - 15/05/2013 17/05/2013 ER - TY - Generic T1 - Infanrix Hexa supply situation within EU and related issues Y1 - 2011 A1 - L. Tesolin KW - EU KW - meeting KW - situation JF - Annual OMCL meeting PB - NA CY - NA CP - EDQM U1 - 5110 U2 - 23-27 May 2011 ER - TY - Generic T1 - Hib vaccine long term stability results Y1 - 2010 A1 - L. Tesolin KW - Long-term KW - meeting KW - result KW - results KW - stability KW - Term KW - vaccine JF - Annual OMCL meeting PB - NA CY - NA CP - EDQM U1 - 5108 U2 - 17-21 May 2010 ER - TY - RPRT T1 - Informal consultation with the ad hoc committee on vaccines prequalification for the revision of the procedure for assessing the acceptability, in principle, of vaccines for purchase by UN agencies Y1 - 2010 A1 - L. Tesolin ER - TY - Generic T1 - Standard Operating Procedure (SOP) template Y1 - 0 A1 - Maxime Vermeulen A1 - L. Tesolin A1 - Alexandre Dobly ER -