· Memorandum of Understanding with AstraZeneca for the preliminary formalization of the ETEC |
· Design of the project's management and governance method |
· Technological Order Contract (ETEC) |
· Design of the integrated vision of the towers, fronts, and project deadlines |
· Additive term of the ETEC contract |
· Permanent alignment of the towers and project fronts |
· Technology Transfer Contract (CTT) |
· (Re) Planning of milestones |
· Additive Term of the CTT |
· Creation and monitoring of project indicators |
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· Monitoring and mitigation of risks to the achievement of the project's objective |
Administrative Management
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Infrastructure Management
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People |
Finance and Budget |
Supply |
Communication and Marketing |
API CHP |
API Warehouse |
New Laboratories Quality Control |
· Identification of qualitative and quantitative workforce needs for technology transfer, production, and delivery of the COVID-19 vaccine |
· Planning and budgetary and financial execution of the budget received through extraordinary credits, in Provisional Measures |
· Identification of the needs for the acquisition of inputs, services, equipment, works, and engineering services, among others, to support the technology transfer process, and production and supply of the vaccine against COVID-19Definition of supply strategies |
· Development of the marketing plan for the vaccine against COVID-19 |
· Adequacy of an API production area of approximately 1200 m2 |
· Area, with 400 m2, 32 freezers for API storage, and 8 cryobanks (cell bank storage equipment) |
· New Physical-Chemical Laboratory: the building has approximately 1,450 m2 of constructed area, with two functional floors and a technical floor. It includes civil works, utility installation, including special gases, air conditioning systems, furniture, and some equipment belonging to the facilities (exhaustion hoods and autoclave for example). |
· Workforce prospection plan |
· Planning, execution, and monitoring of the resources coming from donors |
· Description of procurement and service contracting items |
· Development and updating of the communication plan with actions related to the fight against the pandemic, including a definition of a target audience, media, and instruments, among others |
· Mechanical and automation systems adaptation of 16 air handling units, balancing and certification of approximately 1900 m2 of classified areas for API production |
· Monitoring system for API storage equipment and cell banks; |
· The hiring of new and/or moving employees |
· Elaboration of the project's Economic and Financial Feasibility Study |
· Alignment of critical materials arrival expectations to the overall project schedule |
· FAQ development |
· Installation and qualification of about 75 new process equipment for API production; |
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· Familiarization process for new employees |
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· Alignment with various stakeholders to ensure critical logistics operations (e.g. Importation of API) |
· Publications in Social Networks |
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· Operational Technical Training Program |
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· Creation of editorials for better understanding of the public |
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· Internal communication plans for employees |
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· Creation of visual identity for vaccine communications |
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· Monitoring Panel for costs and investments in personnel related to the transfer of technology, and production and supply of the vaccine against COVID-19. |
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· Elaboration of press releases; |
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· Media training for spokespeople |
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Technology Transfer
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Regulatory Compliance
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TT FP |
TT API |
TT QC |
Production Chain |
· Creation of the functional logic and operationalization of the API storage area |
· Elaboration of Process and Validation Documents for API production and quality control |
· Elaboration of procedures and analytical reports and validation protocols |
· Incorporation of production and quality control processes into the routine |
· Vaccine Pre-registration |
· Receipt of the first shipment of API |
· Receipt of cell bank for thawing test |
· Performance of assays for training and viability of methods |
· Definition and sequencing of the production chain activities |
· Authorization for Emergency Use of the vaccine and the |
· Production of the first batches of the Covid-19 vaccine |
· Receipt of cell and virus banks sufficient for the production of 10 batches of API |
· Performance of tests for analytical validation and preparation of reports |
· Definition of the production master data (e.g., material tree) and registration in the ERP |
· Definitive vaccine registration |
· First delivery to the Ministry of Health of the batches produced with imported API |
· Preparation of the first batch of culture medium |
· Internalization of the tests for the liberation of inputs, raw materials, and imported API received |
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· CTO (Technical Operational Certificate) of the national API production area |
· Delivery of over 155.1 million doses of the vaccine by 02/04/2022. |
· Conducting the first thawing test |
· Internalization of in-process control tests of final processing |
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· Guarantee of good practices, Biosafety, Occupational Safety, and environmental conditions in the facilities and the production process, quality control of the vaccine against COVID-19 |
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· Production of pre-validation batches |
· Internalization of the tests for releasing lots of national API |
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· Production of validation batches |
· Internalization and/or contracting of in-process control tests of API production |
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· Preparation of regulatory documentation |
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· Delivery of final product doses produced with national API. |
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