PILOT PROCESS
PLATFORM
The center has two pilot-scale production platforms, namely the biomanufacturing pilot‑scale Platform and the enzyme engineering pilot platform.
1.Biomanufacturing Pilot‑scale Platform
This platform functions as the core hub bridging laboratory small‑scale research and industrial large‑scale production. It targets key industry bottlenecks including challenging bioprocess scale‑up, process instability, and poor manufacturability for mass production. The platform delivers process scaling‑up, parameter optimization, process standardization and stability validation for diverse bioprocess systems. It addresses critical bottlenecks restricting the industrial translation of research outcomes, and effectively improves the efficiency of technology deployment and transformation.
The platform is staffed by an experienced, multi‑skilled technical team. Core members possess long‑standing expertise in bioprocess development, scale‑up, production quality control and large‑scale manufacturing management. Well‑versed in the scaling principles of microbial fermentation and product synthesis, the team can accurately diagnose and resolve practical issues encountered in pilot operations, such as process drift, low conversion efficiency and system instability. This ensures that developed processes are readily transferable to large‑scale production environments.
The platform occupies around 1,565 m², with comprehensive and mature hardware facilities. It is equipped with multiple 30 L and 50 L fully‑automated fermenters, three 5‑ton automated fermenters, and more than 90 sets of integrated extraction and freeze‑drying equipment. A complete pilot‑scale production workflow is established, covering fermentation‑based synthesis, product separation, purification and low‑temperature drying. The platform can independently execute the full workflow: from lab‑scale process exploration, pilot‑scale validation, parameter optimization and finalization, to product preparation. Through iterative pilot trials, processes are continuously refined to mitigate production risks, lower manufacturing costs and shorten project lead‑time. It provides robust process and hardware support for the large‑scale, standardized manufacturing of various bioprocess‑based projects.
2. Enzyme Engineering Pilot Platform
This platform focuses on the pilot-scale development and process implementation of high-end enzyme preparations, with a particular emphasis on the industrial-scale amplification of high-precision enzymes such as molecular enzymes and diagnostic enzymes. It fills the gap in the process transition from laboratory research to mass production for high-end enzymes. The platform, considering the high purity requirements, strict activity stability, and high precision of production processes of high-end enzyme preparations, concentrates on optimizing the pilot-scale process of enzyme preparations, standardizing the production process, and establishing a product quality control system, helping high-end enzyme products achieve domestication and large-scale production.
The core team of the platform consists of technical personnel who have long been engaged in the research, process amplification, and production application of high-end enzymes. They are deeply involved in the modification of molecular enzymes, the preparation of diagnostic enzymes, and the optimization of enzyme preparation processes. They are familiar with the production characteristics and quality control standards of high-end enzymes and can specifically solve technical problems such as activity loss, non-compliance with purity standards, and poor batch stability during the pilot-scale process of high-end enzymes. The platform has a dedicated 100+ sets of specialized equipment for high-end enzyme pilot-scale, which are suitable for the pilot production of precision enzyme preparations such as molecular enzymes and diagnostic enzymes. It has established a standardized and refined high-end enzyme pilot-scale production line. It can fully cover the entire pilot-scale process of enzyme preparation, including enzyme gene expression, protein purification, enzyme activity regulation, refinement and purification, product preparation and detection calibration. It can quickly complete the process verification, batch trial production, and parameter solidification of high-end enzyme products, providing high-quality, scalable high-end enzyme preparation products and mature supporting processes for the fields of diagnostic reagents, high-end biocatalysis, and biomedicine.
