INFLUENZA VACCINE PROJECT AT BIRMEX · INFLUENZA VACCINE PROJECT AT BIRMEX as by March 14th, 2014...
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INFLUENZA VACCINE PROJECT AT BIRMEX as by March 14 th , 2014 Influenza Project Team* Laboratorios de Biológicos y Reactivos de México, S.A. de C.V. (BIRMEX). Background BIRMEX is the State-owned company for vaccine manufacture and supply in Mexico. The Mexican Federal Ministry of Health is its major shareholder, and BIRMEX activities are aligned to the National Immunization Program, as well as specific activities related to immunization in the country. Since 2004, Mexico started a series of activities aimed at the prevention and control of seasonal and, eventually, pandemic influenza, such as include the use of the seasonal vaccine to immunize high-risk groups, and launch a project to consolidate vaccine production inside the country. For this last, BIRMEX established a join venture with Sanofi-Pasteur for the production of influenza vaccine in Mexico, and the main component of such agreement was a Technology Transference package for filling/packing the vaccine in a multipurpose plant build by BIRMEX in Mexico City. In the context of the Global Pandemic Influenza Action Plan (GAP) of the World Health Organization (WHO), to increase vaccine supply worldwide, in 2007 BIRMEX was selected by WHO to be part of the manufacturers grantees. Since then, BIRMEX has received 4 grants (2008, 2010, 2012, and 2013), representing 5% of the total investment. STATUS OF THE PROJECT As by middle March, 2014, the overall advance of the project is estimated in about 72%. I. CONSTRUCTION: • Facilities (architecture): overall advance of 72% (Fig. 1 and 3). • Services for Production and QC Laboratories: during the last year, the following services were settled in place, and preliminary functioning test were done: Electricity (2 new sub-stations and emergency plants). Fire fight system (Fig. 7). Water supply (cold and heated by boilers) (Fig. 2). Drainage system. Steam (industrial and clean). Air purification (HVAC) system (Fig. 4, Fig. 6). Purified Water , and Water For Injection (WFI) (Fig. 5). Cold rooms (Fig. 8). II. EQUIPMENT: • The major equipment was already acquired and installed (Fig. 10 and 11). • Minor equipment, and stainless steel laboratory furniture will be acquire this year. III. MANAGEMENT: • During the last year, some changes have occurred in the project administration: New Director General at BIRMEX. New Administration and Engineering Directors. Changes in the Administration Board. New dispositions at the Ministry of Health related to the area responsible of BIRMEX. • Licenses renewed: Construction (3). Environmental impact (1). • Budget: The project has received approximately 65.2 mill USD, and 300,000 are remaining for the final stage. WHO contributions has represented 5% of the total investment of the project. • Audits: Local / National (Federal Superior Auditory, Ministry of Finance, Ministry of Public Function, Administration Board, Municipal). External (WHO [Fig. 9], BARDA, CDC, HHS, Sanofi-Pasteur). • Political commitment: Ministry of Health (MoH) made a visit to the Plant facilities (Fig. 12), and did manifest her support to the project, specifically through the provision of 22.2 mill USD of Federal funds for the last stage of the project. IV. TECHNOLOGY TRANSFERENCE: • The Documentation stage has been practically concluded. • When operations start, the in place implementation stage will start. Conclusions • The construction activities will be completed by the end of 2014. • Commissioning activities will start in Q4-2014. • Qualification and Validation will start in Q2-2015. • The budget for the last stage is guarantee (construction, equipment, services, etc.). • The political commitment is imperative during the last stage of the project. Fig. 10. Autoclave in place. Oct/2013. Fig. 1. Main corridor. Production Laboratory. Feb/2014. Fig. 5. WFI system. Feb/2014. Fig. 7. Fire fight system. Oct/2012. Fig. 2. Boilers. Oct/2012. Fig. 4. HVAC Towers. Mar/2014. . Fig. 12. Visit of the MoH. Mar/2014. From left to right, Eduardo Arce, Mexico General Manager Sanofi- Pasteur; Mercedes Juan, MoH; Rafael López, General Director BIRMEX; and Pablo Kuri, Under-Ministry of Health. Influenza Project Team: Rocío Cervantes R; Ruth Velázquez F; Angélica López S; José Bugarín G; Pedro García B; Carlos E. Millán J; Joel Vargas G; Ladislao Monrroy T; Nancy P. Aguilar D; Jonathan Güendulain S; Juan R. Mijares E; and Olinda Carrillo S. Contact: RCR ([email protected]), and RVF ([email protected]). Acknowledgment. The authors wish to express its grateful to Mauricio Rodríguez, for his assistance in the preparation of this poster. Additional activities • In the last three years, BIRMEX personnel (11) has received training support from the Biomedical Advanced Research and Development Authority (BARDA) from the US, in topics related to production and QC/QA of the influenza vaccine. • An initial approach between BIRMEX and the Formulation Laboratory of the University of Lausanne has been done, in order to identify potential collaborations regarding vaccine adjuvants, particularly for a pandemic vaccine. Fig. 3. QC Laboratory. Feb/2014. Fig. 11. Filling line at FAT tests. Sep/2009. Fig. 6. AHU. Mar/2014. 7th Meeting with International Partners on Prospects for Influenza Vaccine Technology Transfer to Developing Country Vaccine Manufacturers. Dubai, UAE, 25-26 March 2014. Fig. 8. Cold rooms. Jun/2012. . Fig. 9. WHO representatives visit to the Production Laboratory Construction. (A) Jan/2014; (B) Oct/2012. (A) (B)
Transcript of INFLUENZA VACCINE PROJECT AT BIRMEX · INFLUENZA VACCINE PROJECT AT BIRMEX as by March 14th, 2014...
INFLUENZA VACCINE PROJECT AT BIRMEX as by March 14th, 2014
Influenza Project Team* Laboratorios de Biológicos y Reactivos de México, S.A. de C.V. (BIRMEX).
Background
BIRMEX is the State-owned company for vaccine manufacture and supply in Mexico. The Mexican Federal Ministry of Health is its major shareholder, and BIRMEX activities are aligned to the National Immunization Program, as well as specific activities related to immunization in the country. Since 2004, Mexico started a series of activities aimed at the prevention and control of seasonal and, eventually, pandemic influenza, such as include the use of the seasonal vaccine to immunize high-risk groups, and launch a project to consolidate vaccine production inside the country. For this last, BIRMEX established a join venture with Sanofi-Pasteur for the production of influenza vaccine in Mexico, and the main component of such agreement was a Technology Transference package for filling/packing the vaccine in a multipurpose plant build by BIRMEX in Mexico City. In the context of the Global Pandemic Influenza Action Plan (GAP) of the World Health Organization (WHO), to increase vaccine supply worldwide, in 2007 BIRMEX was selected by WHO to be part of the manufacturers grantees. Since then, BIRMEX has received 4 grants (2008, 2010, 2012, and 2013), representing 5% of the total investment.
STATUS OF THE PROJECT As by middle March, 2014, the overall advance of the project is estimated in about 72%. I. CONSTRUCTION:
• Facilities (architecture): overall advance of 72% (Fig. 1 and 3). • Services for Production and QC Laboratories: during the last year, the following
services were settled in place, and preliminary functioning test were done: Electricity (2 new sub-stations and emergency plants). Fire fight system (Fig. 7). Water supply (cold and heated by boilers) (Fig. 2). Drainage system. Steam (industrial and clean). Air purification (HVAC) system (Fig. 4, Fig. 6). Purified Water , and Water For Injection (WFI) (Fig. 5). Cold rooms (Fig. 8).
II. EQUIPMENT: • The major equipment was already acquired and installed (Fig. 10 and 11). • Minor equipment, and stainless steel laboratory furniture will be acquire this year.
III. MANAGEMENT:
• During the last year, some changes have occurred in the project administration: New Director General at BIRMEX. New Administration and Engineering Directors. Changes in the Administration Board. New dispositions at the Ministry of Health related to the area responsible of
BIRMEX. • Licenses renewed:
Construction (3). Environmental impact (1).
• Budget: The project has received approximately 65.2 mill USD, and 300,000 are
remaining for the final stage. WHO contributions has represented 5% of the total investment of the project.
• Audits: Local / National (Federal Superior Auditory, Ministry of Finance, Ministry of
Public Function, Administration Board, Municipal). External (WHO [Fig. 9], BARDA, CDC, HHS, Sanofi-Pasteur).
• Political commitment: Ministry of Health (MoH) made a visit to the Plant facilities (Fig. 12), and did
manifest her support to the project, specifically through the provision of 22.2 mill USD of Federal funds for the last stage of the project.
IV. TECHNOLOGY TRANSFERENCE:
• The Documentation stage has been practically concluded. • When operations start, the in place implementation stage will start.
Conclusions • The construction activities will be completed by the end of 2014. • Commissioning activities will start in Q4-2014. • Qualification and Validation will start in Q2-2015. • The budget for the last stage is guarantee (construction, equipment, services,
etc.). • The political commitment is imperative during the last stage of the project.
Fig. 10. Autoclave in place. Oct/2013.
Fig. 1. Main corridor. Production Laboratory. Feb/2014.
Fig. 5. WFI system. Feb/2014.
Fig. 7. Fire fight system. Oct/2012.
Fig. 2. Boilers. Oct/2012.
Fig. 4. HVAC Towers. Mar/2014. .
Fig. 12. Visit of the MoH. Mar/2014. From left to right, Eduardo Arce, Mexico General Manager Sanofi-Pasteur; Mercedes Juan, MoH; Rafael López, General Director BIRMEX; and Pablo Kuri, Under-Ministry of Health.
Influenza Project Team: Rocío Cervantes R; Ruth Velázquez F; Angélica López S; José Bugarín G; Pedro García B; Carlos E. Millán J; Joel Vargas G; Ladislao Monrroy T; Nancy P. Aguilar D; Jonathan Güendulain S; Juan R. Mijares E; and Olinda Carrillo S. Contact: RCR ([email protected]), and RVF ([email protected]).
Acknowledgment. The authors wish to express its grateful to Mauricio Rodríguez, for his assistance in the preparation of this poster.
Additional activities • In the last three years, BIRMEX personnel (11) has received training support from the
Biomedical Advanced Research and Development Authority (BARDA) from the US, in topics related to production and QC/QA of the influenza vaccine.
• An initial approach between BIRMEX and the Formulation Laboratory of the University of Lausanne has been done, in order to identify potential collaborations regarding vaccine adjuvants, particularly for a pandemic vaccine.
Fig. 3. QC Laboratory. Feb/2014.
Fig. 11. Filling line at FAT tests. Sep/2009.
Fig. 6. AHU. Mar/2014.
7th Meeting with International Partners on Prospects for Influenza Vaccine Technology
Transfer to Developing Country Vaccine Manufacturers.
Dubai, UAE, 25-26 March 2014.
Fig. 8. Cold rooms. Jun/2012. .
Fig. 9. WHO representatives visit to the Production Laboratory Construction. (A)
Jan/2014; (B) Oct/2012.
(A) (B)
