Full Name
Irma Riyanti
Speaker Bio
Personal Statement
I have worked in the pharmaceutical industry since 2002 and joined Bio Farma since September 2002 as a bacterial vaccine quality control staff, and responsible for biological testing related to vaccines and serum, such as testing for potency, toxicity, identity (in vivo and in vitro), vaccine stability programs, development of new test methods and validation/verification of test methods.
In 2005 I moved to chemical and physical quality control department, responsible for chemical and physical testing of vaccines (bacteria and viruses), sampling and testing of raw materials & packaging and testing of water monitoring used in production and QC. In 2019 I moved back to the bacterial vaccine quality control department.
I am involved in several project teams including the project auction team, the energy saving team, innovation committee, vaccine technology transfer, both as a technology recipient and as a technology provider/sender, such as with Biovac-South Africa (Pentavalent liquid vaccine), Arabio (Td vaccine), Sanofi and Biken (IPV/sIPV vaccine), Luzhu (Meningitis), and ALS-Ghana (Td vaccine).
From 2005 to present I have been a team of internal and external auditors of Bio Farma, including auditors related to GMP aspects, ISO (9001, 14001 and 18001) including as a BNSP auditor (professional certification auditor). Experienced in external audits both domestically and abroad, including supplier vendors such as raw material and packaging material, external calibration laboratories and several visits to external vendors for benchmarking (Klockner Pentaplast-Thailand) and visit of Pentavalent RTF production capability (Cadilla-India).
Several test collaborations that have been carried out are related to protein testing of Hepatitis B with Berna Biotech (Korea), SII and BBIL (India). Until now, I have actively participated in collaborations related to new biological standard candidates with NIBSC/MHRA, for example for several new candidate biological standards, and proficiency testing (ATP for BCG vaccine, IBP Thailand)
In 2019 I joined the 3Rs DCVMN working group and participated in several projects such as PSPT (Pertussis Serological Potency Test) and multi dilution assay (MDA) for potency testing. The results of this PSPT collaboration have been published in journals published in WHO Drug Information and Preprints.
From 2022 until now I have joined HSI (Human Society International) as a Steering Group and in this Steering Group we discuss all issues related to 3Rs, regulation and what are the obstacles in implementing 3Rs.
As industry representative, I actively participate in reviewing, correcting the draft of the Indonesian pharmacopoeia that is currently being prepared, TRS draft related to 3Rs, providing corrections, suggestions and input regarding implementation and obstacles in the field before this document is ratified and used. Participate in WHO workshop, DCVMN meeting also HSI meeting as steering group member.
I have been a speaker at the Indonesian NRA event, with the topic QC related such us sampling (products, raw materials and packaging) and have also been a speaker on vaccine quality control (Imapac, Singapore, 2022), providing training to NRA on several new tests and collaboration for standardization of national reference standard with NRA.
Contibute in developed a new test related to the 3Rs principle, the development of specific toxicity tests and irreversibility tests on bulk diphtheria and tetanus with cell base method. In addition, exploring the change of tests from pyrogen to MAT (Monocyte Activation Test), change of Multi Dilution Assay (MDA) to Single Dilution Assay (SDA) in potency test.
Several trainings related to production, QMS, project transfer, process validation, cleaning validation, GMP aspects, vaccine quality testing, test method validation, data integrity have been attended both domestically and abroad.
In summary, I have the expertise, leadership, training, experience related to the biopharmaceutical industry, especially vaccines and motivation in learning new things and new projects.
Citations:
1. Christina, VH., Tim, S., Irma., R (2023). Potency Testing of Whole Cell Pertussis Containing Vaccines : Lesson Learned in a Multi Laboratory Assesment of the Pertussis Serological Potency Test. Preprints. DOI : 10.20944
B. Positions, Scientific Appointments, and Honors
Positions and Scientific Appointments
2023 - Present HSI (Human Society International), Steering Group Member
2020 - 2022 DCVMN, PSPT Consortium Member
2019 - 2022 DCVMN, 3Rs Working Group Member
2023 - Present Td Transfer Project Team, BF- ALS Ghana
2005 – Present Bio Farma Auditor Team
06/2019 – Present Bio Farma, Head of Bacterial Vaccine QC Department
09/2006 – 06/2019 Bio Farma, Head of Chemical and Physical QC Department
07/2005 – 07/2006 Bio Farma, Chemical and Physical QC Staff
10/2002 – 06/2005 Bio Farma, Bacterial Vaccine QC Staff
01/2002 – 09/2002 Sanbe Farma, Beta lactam and Cephalosphorine IPC supervisor
C. Contributions to Science
1. My initial publication was related to the PSPT project organized by DCVMN. In the project, Bio Farma became one of the organizations participating in this project to conduct PSPT tests and compare the test results with existing methods (Challenge method / Kendrick Test) with varied test materials.
The test results from participants were used as the basis for determining the next stage when this method would be used and implemented. The final project was met in New Delhi on 5-6 July 2022 and the results of this project were submitted to a journal that had been published through preprints (Nov 2023) and had been included in WHO Drug Information (2024).
a. Christina, VH., Tim, S., Irma., R (2023). Potency Testing of Whole Cell Pertussis Containing Vaccines : Lesson Learned in a Multi Laboratory Assesment of the Pertussis Serological Potency Test. Preprints. DOI : 10.20944 ; WHO Drug Information Volume 38, Number 4, p. 981 - 1009
2. The next publication is to actively participate in the WHO workshop on standard references, problems and how to maintain standard references in each manufacturer and discussions on the problem solving provided. The workshop was held in Bali, November 2023 with a published workshop report.
a. WHO, Dianliang Lei, Irma R, Report of a WHO workshop on implementation of the WHO manual for the preparation of reference materials for use as secondary standards in antibody testing, 2023,14-16 November, Denpasar, Indonesia. https://cdn.who.int/media/docs/default-source/biologicals/report-who-workshop-secstd-manual_final.pdf?sfvrsn=36229937_1&download=true
3. Actively participate in reviewing, correcting, analyzing the latest reference draft before it is approved and published. Participation in the WHO TRS review of the 3Rs policy which is still in draft status and will be finalized in 2025, October.
a. WHO, Dianliang Lei, Irma R ; Guidelines on the phasing out of animal tests for the quality
control of biological products (draft).,
https://cdn.who.int/media/docs/default-source/biologicals/call-for-comments/who-guideline-on-3rs---draft-1-version-29-nov-2024-pc_clean.pdf?sfvrsn=7809e18d_1
4. Actively participate in the collaboration of the latest NIBSC/MHRA biological standard candidates and report the results of the collaboration to the organizers.
a. Laura Hassall, Peter Rigsby, Paul Sticking, Irma Riyanti; Collaborative study for the calibration of a replacement International Standard for Diphtheria Antitoxin Equine, 2023, Biologicals https://pubmed.ncbi.nlm.nih.gov/37149975/
b. Shalini Rajagopal, Robert Tierney, Peter Rigsby, Paul Stickings, Dori Ugiyadi; Collaborative study: Calibration of 1st WHO Reference Reagent for Tetanus Antitoxin Equine for use in Flocculation Test; https://cdn.who.int/media/docs/default-source/biologicals/bs-documents-(ecbs)/2022-documents/new-2022-document-susan/bs-2022.2431_rajagopal--s_who-rr-for-tetanus-antitoxin-for-flocculatin-test_final.pdf?sfvrsn=1e942761_1&download=true
I have worked in the pharmaceutical industry since 2002 and joined Bio Farma since September 2002 as a bacterial vaccine quality control staff, and responsible for biological testing related to vaccines and serum, such as testing for potency, toxicity, identity (in vivo and in vitro), vaccine stability programs, development of new test methods and validation/verification of test methods.
In 2005 I moved to chemical and physical quality control department, responsible for chemical and physical testing of vaccines (bacteria and viruses), sampling and testing of raw materials & packaging and testing of water monitoring used in production and QC. In 2019 I moved back to the bacterial vaccine quality control department.
I am involved in several project teams including the project auction team, the energy saving team, innovation committee, vaccine technology transfer, both as a technology recipient and as a technology provider/sender, such as with Biovac-South Africa (Pentavalent liquid vaccine), Arabio (Td vaccine), Sanofi and Biken (IPV/sIPV vaccine), Luzhu (Meningitis), and ALS-Ghana (Td vaccine).
From 2005 to present I have been a team of internal and external auditors of Bio Farma, including auditors related to GMP aspects, ISO (9001, 14001 and 18001) including as a BNSP auditor (professional certification auditor). Experienced in external audits both domestically and abroad, including supplier vendors such as raw material and packaging material, external calibration laboratories and several visits to external vendors for benchmarking (Klockner Pentaplast-Thailand) and visit of Pentavalent RTF production capability (Cadilla-India).
Several test collaborations that have been carried out are related to protein testing of Hepatitis B with Berna Biotech (Korea), SII and BBIL (India). Until now, I have actively participated in collaborations related to new biological standard candidates with NIBSC/MHRA, for example for several new candidate biological standards, and proficiency testing (ATP for BCG vaccine, IBP Thailand)
In 2019 I joined the 3Rs DCVMN working group and participated in several projects such as PSPT (Pertussis Serological Potency Test) and multi dilution assay (MDA) for potency testing. The results of this PSPT collaboration have been published in journals published in WHO Drug Information and Preprints.
From 2022 until now I have joined HSI (Human Society International) as a Steering Group and in this Steering Group we discuss all issues related to 3Rs, regulation and what are the obstacles in implementing 3Rs.
As industry representative, I actively participate in reviewing, correcting the draft of the Indonesian pharmacopoeia that is currently being prepared, TRS draft related to 3Rs, providing corrections, suggestions and input regarding implementation and obstacles in the field before this document is ratified and used. Participate in WHO workshop, DCVMN meeting also HSI meeting as steering group member.
I have been a speaker at the Indonesian NRA event, with the topic QC related such us sampling (products, raw materials and packaging) and have also been a speaker on vaccine quality control (Imapac, Singapore, 2022), providing training to NRA on several new tests and collaboration for standardization of national reference standard with NRA.
Contibute in developed a new test related to the 3Rs principle, the development of specific toxicity tests and irreversibility tests on bulk diphtheria and tetanus with cell base method. In addition, exploring the change of tests from pyrogen to MAT (Monocyte Activation Test), change of Multi Dilution Assay (MDA) to Single Dilution Assay (SDA) in potency test.
Several trainings related to production, QMS, project transfer, process validation, cleaning validation, GMP aspects, vaccine quality testing, test method validation, data integrity have been attended both domestically and abroad.
In summary, I have the expertise, leadership, training, experience related to the biopharmaceutical industry, especially vaccines and motivation in learning new things and new projects.
Citations:
1. Christina, VH., Tim, S., Irma., R (2023). Potency Testing of Whole Cell Pertussis Containing Vaccines : Lesson Learned in a Multi Laboratory Assesment of the Pertussis Serological Potency Test. Preprints. DOI : 10.20944
B. Positions, Scientific Appointments, and Honors
Positions and Scientific Appointments
2023 - Present HSI (Human Society International), Steering Group Member
2020 - 2022 DCVMN, PSPT Consortium Member
2019 - 2022 DCVMN, 3Rs Working Group Member
2023 - Present Td Transfer Project Team, BF- ALS Ghana
2005 – Present Bio Farma Auditor Team
06/2019 – Present Bio Farma, Head of Bacterial Vaccine QC Department
09/2006 – 06/2019 Bio Farma, Head of Chemical and Physical QC Department
07/2005 – 07/2006 Bio Farma, Chemical and Physical QC Staff
10/2002 – 06/2005 Bio Farma, Bacterial Vaccine QC Staff
01/2002 – 09/2002 Sanbe Farma, Beta lactam and Cephalosphorine IPC supervisor
C. Contributions to Science
1. My initial publication was related to the PSPT project organized by DCVMN. In the project, Bio Farma became one of the organizations participating in this project to conduct PSPT tests and compare the test results with existing methods (Challenge method / Kendrick Test) with varied test materials.
The test results from participants were used as the basis for determining the next stage when this method would be used and implemented. The final project was met in New Delhi on 5-6 July 2022 and the results of this project were submitted to a journal that had been published through preprints (Nov 2023) and had been included in WHO Drug Information (2024).
a. Christina, VH., Tim, S., Irma., R (2023). Potency Testing of Whole Cell Pertussis Containing Vaccines : Lesson Learned in a Multi Laboratory Assesment of the Pertussis Serological Potency Test. Preprints. DOI : 10.20944 ; WHO Drug Information Volume 38, Number 4, p. 981 - 1009
2. The next publication is to actively participate in the WHO workshop on standard references, problems and how to maintain standard references in each manufacturer and discussions on the problem solving provided. The workshop was held in Bali, November 2023 with a published workshop report.
a. WHO, Dianliang Lei, Irma R, Report of a WHO workshop on implementation of the WHO manual for the preparation of reference materials for use as secondary standards in antibody testing, 2023,14-16 November, Denpasar, Indonesia. https://cdn.who.int/media/docs/default-source/biologicals/report-who-workshop-secstd-manual_final.pdf?sfvrsn=36229937_1&download=true
3. Actively participate in reviewing, correcting, analyzing the latest reference draft before it is approved and published. Participation in the WHO TRS review of the 3Rs policy which is still in draft status and will be finalized in 2025, October.
a. WHO, Dianliang Lei, Irma R ; Guidelines on the phasing out of animal tests for the quality
control of biological products (draft).,
https://cdn.who.int/media/docs/default-source/biologicals/call-for-comments/who-guideline-on-3rs---draft-1-version-29-nov-2024-pc_clean.pdf?sfvrsn=7809e18d_1
4. Actively participate in the collaboration of the latest NIBSC/MHRA biological standard candidates and report the results of the collaboration to the organizers.
a. Laura Hassall, Peter Rigsby, Paul Sticking, Irma Riyanti; Collaborative study for the calibration of a replacement International Standard for Diphtheria Antitoxin Equine, 2023, Biologicals https://pubmed.ncbi.nlm.nih.gov/37149975/
b. Shalini Rajagopal, Robert Tierney, Peter Rigsby, Paul Stickings, Dori Ugiyadi; Collaborative study: Calibration of 1st WHO Reference Reagent for Tetanus Antitoxin Equine for use in Flocculation Test; https://cdn.who.int/media/docs/default-source/biologicals/bs-documents-(ecbs)/2022-documents/new-2022-document-susan/bs-2022.2431_rajagopal--s_who-rr-for-tetanus-antitoxin-for-flocculatin-test_final.pdf?sfvrsn=1e942761_1&download=true
