© 2024 by Mares ITX GmbH.
From cutting-edge research to tissue engineering and vaccine development, our clients develop and enhance novel concepts using the best technologies. For instance, several innovative projects from our clients involve academic institutions and small-scale companies, primarily dedicated to research and development.
The research is focused towards obtaining results efficiently, adhering to clinical trial applications.
At Mares, research is conducted thoroughly ensuring results for clinical trials. Our expertise lies in Good Laboratory Practices (GLP) and approval from regulatory authorities.
Research & development environments are important for processes involving Advanced Therapy production. The ingredients, resources and processes used for Advanced Therapies for human application requires compliance in terms of medicinal products and production processes that will have to meet Good Manufacturing Practice (GMP) benchmarks.
As for Advanced Therapy, certain agents and components, which are not used for manufacturing medicinal products presents a difficult scenario regarding approvals.
One example that stands out is of Bovine Serum Products - a complex product of animal origin that requires safeguarding against the transmission of Bovine pathogens like Transmissible Spongiform Encephalitis (TSE).
Other than regulatory compliance, Advanced Therapies stem from R&D projects where the choice of raw materials is based on specific parameters. The need of the hour - converting processes into a product based on quality standards that are appropriate for human application.
01
Ensure choosing the right materials and technologies.
02
Develop manufacturing processes and adjust your processes so the products meet relevant guidelines, which can be approved and are economically feasible.
Advanced Therapy products usually depend on manual Aseptic processes. As these products cannot be sterilized completely, sticking to an Aseptic status throughout the process is pivotal.
Develop processes and Standard Operating Procedures (SOPs).
Design facilities supporting Aseptic processes based on ISO guidelines, EU-GMP and US requirements.
Have decades of experience in planning facilities and maintaining hygiene ranging from class A to class D.
Manufacturing ATMPs require few production units while clinical trials may need hundreds. Similarly, commercial scale manufacturing is open-ended.
Technologies that facilitate production of such huge volumes require qualification and validation, which is time consuming. Therefore, they need to be planned in advance to meet requirements as and when needed.
Generally, innovators and researchers choose to produce their products in dedicated facilities. These facilities require special attention as they must be GMP compliant - especially for Aseptic manufacturing.
Mares ITX, with decades of experience and expertise in developing and planning cell processing and tissue engineering plants ensures that your facility complies with the highest standards.
For our client Stempeutics, Mares provides strategic, technological advice and hands-on support for production of stem cell-based drugs and cosmetics.
Stempeutics is a renowned stem cell company developing stem cell-based medicinal products with state-of-the-art facilities in India (Bangalore & Manipal) and Malaysia (Kuala Lumpur).
Started in January 2006, the strength of Stempeutics lies in producing stem cell products using cutting-edge technology to nurture the best clinical applications through a highly committed team.
Every development and manufacturing procedure relies on devices, tools and processes. According to Pharmaceutical guidelines, qualification of all devices & validation of processes is important.
Based on our expertise, Mares ITX provides qualification and validation services that adhere to EU requirements. Furthermore, Mares ITX has experience in developing some of the best Aseptic manufacturing processes, controls and facilities.
From cutting-edge research to tissue engineering and vaccine development, our clients develop and enhance novel concepts using the best technologies. For instance, several innovative projects from our clients involve academic institutions and small-scale companies, primarily dedicated to research and development.
The research is focused towards obtaining results efficiently, adhering to clinical trial applications.
At Mares, research is conducted thoroughly ensuring results for clinical trials. Our expertise lies in Good Laboratory Practices (GLP) and approval from regulatory authorities.
Research & development environments are important for processes involving Advanced Therapy production. The ingredients, resources and processes used for Advanced Therapies for human application requires compliance in terms of medicinal products and production processes that will have to meet Good Manufacturing Practice (GMP) benchmarks.
As for Advanced Therapy, certain agents and components, which are not used for manufacturing medicinal products presents a difficult scenario regarding approvals.
One example that stands out is of Bovine Serum Products - a complex product of animal origin that requires safeguarding against the transmission of Bovine pathogens like Transmissible Spongiform Encephalitis (TSE).
Other than regulatory compliance, Advanced Therapies stem from R&D projects where the choice of raw materials is based on specific parameters. The need of the hour - converting processes into a product based on quality standards that are appropriate for human application.
01
Ensure choosing the right materials and technologies.
02
Develop manufacturing processes and adjust your processes so the products meet relevant guidelines, which can be approved and are economically feasible.
Advanced Therapy products usually depend on manual Aseptic processes. As these products cannot be sterilized completely, sticking to an Aseptic status throughout the process is pivotal.
Develop processes and Standard Operating Procedures (SOPs).
Design facilities supporting Aseptic processes based on ISO guidelines, EU-GMP and US requirements.
Have decades of experience in planning facilities and maintaining hygiene ranging from class A to class D.
Manufacturing ATMPs require few production units while clinical trials may need hundreds. Similarly, commercial scale manufacturing is open-ended.
Technologies that facilitate production of such huge volumes require qualification and validation, which is time consuming. Therefore, they need to be planned in advance to meet requirements as and when needed.
Generally, innovators and researchers choose to produce their products in dedicated facilities. These facilities require special attention as they must be GMP compliant - especially for Aseptic manufacturing.
Mares ITX, with decades of experience and expertise in developing and planning cell processing and tissue engineering plants ensures that your facility complies with the highest standards.
For our client Stempeutics, Mares provides strategic, technological advice and hands-on support for production of stem cell-based drugs and cosmetics.
Stempeutics is a renowned stem cell company developing stem cell-based medicinal products with state-of-the-art facilities in India (Bangalore & Manipal) and Malaysia (Kuala Lumpur).
Started in January 2006, the strength of Stempeutics lies in producing stem cell products using cutting-edge technology to nurture the best clinical applications through a highly committed team.
Every development and manufacturing procedure relies on devices, tools and processes. According to Pharmaceutical guidelines, qualification of all devices & validation of processes is important.
Based on our expertise, Mares ITX provides qualification and validation services that adhere to EU requirements. Furthermore, Mares ITX has experience in developing some of the best Aseptic manufacturing processes, controls and facilities.