Our History
Productive Lines
Located in Garín, Buenos Aires Province, the manufacturing site is of 20,000 m².
Pre-filled syringes Line
Capacity for
0
Million doses
Vial Line
Formats
-
Vials
(2-5-10-20-50ml) - Syringes
- Carpules
Design
-
State-of-the-Art
technology - Versatility and flexibility in the processing of products.
Capacity for
0
400 million doses (estimated
for 10-dose vial)
Site and Industrial area
Bio technological Park (Sinergium, Biogénesis Bagó, Mabxience).
0
Staff members in the area
0
Exclusive site for Sinergium
Antigen Production
Available stocks
in our headquarters
(cell culture, adenovirus, etc.).
in our headquarters
(cell culture, adenovirus, etc.).
To be analyzed
upon each
project.
upon each
project.
Security and Environment
Sinergium Biotech S.A. accepts its social and environmental responsibility by actively working to minimize the environmental impact of its activities. This is achieved through specific action plans and programs designed for:
Energy savings.
Optimization of renewable and non-renewable resources.
Promotion of initiatives in the safety, health, and environmental protection areas.
How do we work at Sinergium Biotech to reduce the environmental impact?
We added 2022 as one more year without any fines nor penalties for breach of employment or environmental laws and rules.
We continued in 2022 with the migration of lighting to LED technology.
We have implemented different initiatives for the recovery and recycling of waste. We recycle around 50% of our waste.
We make donations of plastic, cardboard, and wood pallets –that come from the recycling program- to Fundación Reciduca. The NGO gets its resources from the sales of these materials to grant scholarships to students facing economic vulnerability.
We get compost from our organic waste. We recycle, per year, more than 20 m3 of organic waste and thus we contribute to the reduction of our carbon footprint.
We work with the Asociación Civil María de las Cárceles (civil organization) to reuse elements of electrical and electronic equipment that are close to the end of their service life. So, aside from giving a
new life to consumables, these actions help create new jobs.
We considered the purchase of energetically efficient equipment with lesser water consumption in the expansion of our plant and new equipment.
Printers are Energy Star certified, which guarantees a reduction of between 15% and 30% in the use of energy. Besides, since 2022 each person uses a token to release their printing, which decreases paper consumption.
We also have an agreement with our printer maintenance supplier to reuse toners.
We raise awareness about minimizing the use of fossil fuels, for instance, by promoting carpooling among coworkers.
We added 2022 as one more year without any fines nor penalties for breach of employment or environmental laws and rules. We continued in 2022 with the migration of lighting to LED technology.
Our policy of hygiene, safety, and environment
Sinergium Biotech S.A. develops its activities of manufacturing medicines, assuring the physical integrity of its workers and the protection of the environment.
To reach such goals, the commitments are:
To permanently work to prevent environmental contamination and minimize risks to the health and safety of all the workers in the company.
To determine goals to effectively accomplish with the statements outlined in the Hygiene, safety, and environment policy, allocating the necessary resources
to develop them. We assess its compliance within a continuous improvement process.
To conduct safe and environmentally sustainable processes, complying with all the applicable laws and other requirements the company may adhere to.
This policy shall be available for the community and authorities, encouraging the endorsement of these commitments among staff, contractors, and suppliers.
Regulatory inspections and External audits
Our processes, equipment, and work standards are aligned with the international GMP requirements. This guarantees the quality, safety, and efficiency of the products.
SINERGIUM BIOTECH S.A. complies with the national regulation set forth by the National Administration of Drugs, Foods and Medical Technology of Argentina (ANMAT, its acronym in Spanish), a member of the Pharmaceutical Inspection Co-operation Scheme (PICs).
Certified site for the formulation, filling, and conditioning of biological/biotechnological products (including vaccines).
Regulatory inspections: Russia, Turkey, Jordan, Colombia (INVIMA), Uganda, Panama, Saudi Arabia (SFDA), Belarus, Pakistan.
Quality Policy
Sinergium Biotech is engaged with the manufacturing, control, delivery, and supply of quality vaccine and biotechnological products, safe and efficient for patients.
All the activities carried out at Sinergium Biotech fulfill local and international regulatory requirements and are based upon standards and guidelines of the highest level. We comply with GPM (Good Manufacturing Practice) international regulations. The company’s management is engaged in providing the resources and setting the priorities that are required for compliance with this quality policy.
Management and directors commit to:
Ensure that the quality goals required to implement the quality policy are defined, communicated, and supported at all the appropriate levels of the company.
Provide the necessary resources (human, financial, material, building, and equipment) to implement and sustain the quality system and continuous improvement of its efficiency.
Implement an effective monitoring and control system for the performance of the processes and quality of the products, assuring that the processes
continue to be suitable and adequate.
Carry out regular revisions of the performance of the processes and the quality of products and the quality system through performance indicators.
Guarantee the concept of teamwork among the different departments that form Sinergium Biotech (based on the concept of processes of our own and appropriate communication channels).
Define the responsibilities of the staff that performs and verifies those
activities in which the quality of the product can be affected.
Assure that the documented and controlled processes are implemented and supported.
Guarantee the implementation and support of an effective program of Preventive and Corrective Measures.
Assure that client’s requirements (meaning needs and expectations) are solved, transformed into specific requirements, and fulfilled to achieve satisfaction.
The Quality System, which articulates an integrated concept of quality, is based on the following cornerstones:
- Staff training and qualification.
- Management of preventive and corrective measures (PMCMs).
- Management of risk quality.
- Management of change control.
- Management of quality events.
- Documentation system.
We work with a concept of quality that is integrated and cross-sectional, which assures the implementation of this policy at all company levels.
Sinergium Biotech directors, management, and staff are strongly committed to implementing a total quality system and actively working on continuous improvement and innovation.