Sistemas Biorreactores Producción con esterilización in-situ
Applikon Biotechnology is the global specialist in human vaccine production systems, as well as in systems for the production of therapeutic agents using both cell culture and microbial cultures. Applikon has supplied multiple systems to major vaccine producers worldwide, as well as cGMP systems for producers of MABs for human pharmaceutical applications. Applikon Biotechnology is recognized as the supplier with the highest quality equipment and the most complete cGMP product offering that allows our customers to produce biologicals for worldwide distribution. Through our large number of contacts in the global Biotech industry, Applikon Biotechnology is able to advise and support you in applying the latest standards and techniques for optimal operation and validation of your process.
Key success factors for any project are delivery within the agreed time, costs and specifications. Over the past 40 years we have recognized that when running a project with several parties distributed over the world and in different time zones, good communication is key to a successful realization. We have developed our project management website especially to streamline the communication and information flow for larger projects. This website holds all information and documentation for a project and can be accessed through a 24 hours per day open internet communication channel. You can easily check the most current status of your project and access the drawings, specifications and documents like IQ/OQ/FAT and SAT protocols. The website allows you to view the status of the project to make sure that we are still on track with our schedule and to make sure that we deliver according to planning and contractual agreements. This tool guarantees our customers open communication and prevents surprises arising during realization or after deployment.
Next to a vast range of standard off-the-shelf solutions, Applikon offers customized solutions from small scale to full scale production systems. These customized solutions are tailored to the specific process and customer demands. Customization includes:
- Custom bioreactor volumes
- Custom cleaing installations
- Custom materials or surface finishing
- Custom control solutions
- Custom software solutions
- Integration of 3rd party equipment
All systems are supplied turnkey and fully tested and documented. Clear and continuous communication during design and production of these customized solutions is essential for the success of these complex installations. Our on-line project management center offers our customers 24/7 input and review options during the design, production, and final testing phases. In this way you can always follow the progress of the project, review drawings as they are generated, and review/accept test procedures according to your specific requirements. The fruit of these special projects are systems that are completely designed, tested, and documented according to the wishes of our customers.
Special projects can be single or multiple systems ranging in volume from a few liters R&D systems to several thousands of liters of production volume. Applications range from food processing and enzyme production to vaccine production and monoclonal antibody production systems.
All documents relating to traceable and certified (eventually batch-related) materials are checked, stored, and made available for use in production order-related documentation. All documents are coupled to the components' engraved tracking numbers held in a database. Required documents are defined for each item appearing in the technical drawings. Examples of supplied documents are weld maps, isometrics and welder certificates. All documents can be supplied to the customer upon request.
