Heavy weight! The Ministry of Industry and Information Technology has released the "Guidelines for Pilot Services in Biological Manufacturing"! Which directions have been indicated?
The Ministry of Industry and Information Technology recently released the "Guidelines for Cultivating Pilot Service Platforms in Biological Manufacturing (Draft for Comments)", aiming to standardize and guide the construction and operation of pilot service platforms in biological manufacturing.
This measure indicates that the biomanufacturing industry will usher in a more standardized and systematic development stage!
This document will become an important reference for the future pilot service platform!
Bailun has profound experience in biomanufacturing pilot scale up, service, platform construction, and a large number of pilot platforms are spread all over the world.
Later Bailun Biology will explain this heavy document one by one on the official account!
The "Guide" provides a detailed classification of technical equipment, including general equipment instruments such as bioreactors, centrifuges, chromatography systems, as well as specialized equipment instruments.
Specific equipment recommendations are proposed for different fields such as food and additives, biopharmaceuticals, cosmetics, etc.
This detailed classification aims to enhance the professionalism of the pilot service platform and ensure the efficiency and accuracy of pilot services in various fields.
Venue and Qualification Requirements] In order to ensure the smooth operation of pilot services, the "Guidelines" require pilot service platforms to have independent venues with an area of not less than 3000 square meters and equipped with clean areas, explosion-proof areas, and other on-site conditions.
At the same time, the platform needs to pass safety assessments, environmental impact assessments, and obtain corresponding qualifications. These requirements ensure the safety and compliance of pilot services, providing a solid foundation for innovation in biomanufacturing.
The "Guidelines for Professional Talent Team Building and Technical Service Capability" emphasizes the importance of a professional talent team for pilot service platforms, requiring at least 15 fixed technical team members, including no less than 60% of scientific and technological personnel with master's degrees or intermediate professional titles.
The platform also needs to have engineering and technical capabilities such as fermentation process optimization and scale up, as well as rich experience in pilot service.
These regulations aim to enhance the professional level of pilot services and promote innovation and application of biomanufacturing technology.
The Guidelines for Open Pilot Services and Intellectual Property Management encourage pilot service platforms to provide open pilot services and develop a technology guidance service model based on sharing.
At the same time, clear requirements have been put forward for intellectual property protection, including the establishment of an intellectual property protection department, strict strain management, and confidentiality measures for technical information.
These regulations aim to protect innovative achievements and promote the healthy development of the biomanufacturing industry.
