The plan of the year lies in the spring. The Spring Festival has not completely dissipated. The Winter Olympics are in full swing. In February, the spring city of Jinan turned cold, and the CMC R&D platform of Qilu Pharmaceutical’s innovative biological drugs has already been busy. , a warm scene. From cell line construction to cell culture, from monoclonal antibody purification to biologics, from quality analysis, characterization analysis to project management and registration, dozens of innovative drug and biosimilar drug R&D projects are progressing efficiently at the same time. Whether discussing projects or immersing in experiments, researchers race against time on their respective “fields”, strive for the “medal” in their hearts, sound the “charge” in the laboratory, and run out of the acceleration of biomedical research and development.
“R&D without speed is worthless. R&D and launch of more high-quality and affordable new drugs and good drugs as soon as possible, provide patients with better treatment plans, relieve and eliminate pain as soon as possible, and improve drug use Accessibility, greatly reducing the burden on patients and medical insurance, this is the sacred mission of drug developers. We must fight against every second in every position, and win every ‘relay race’.” Qilu Pharmaceutical Group Biotechnology Development Research Institute Vice President An Zhenming said in an interview.
Today’s Spring Festival is going to the grassroots. Let’s walk into this team that is racing against time, explore the research and development process of biological drugs, and feel the passion of dream chasers.
Based on the latest developments in biopharmaceutical research and development in the fields of process research and quality research, researchers are discussing the work progress and future planning of the quantitative mass spectrometry platform. Focus on technical difficulties, develop advanced platform technologies, reduce development risks, and escort the rapid advancement of the project.
In the cell culture laboratory, dubbed the “BMW parking lot” by outsiders, dozens of cell culture tanks are running efficiently. The key process parameters and performance indicators of the production process are being monitored and detected in real time, and the product quality is ensured from the source through the refined control of the process, and the process of biological drug research and development is rapidly promoted.
In the monoclonal antibody purification laboratory, researchers use the world-class intelligent chromatography system, through DOE tools, rationally design experimental plans, and carry out multiple projects The process development and process characterization work of Qilu are steadily and continuously advanced in the research process, racing against time to seize the quality and take the lead, so as to promote the early launch of Qilu good medicines and benefit the patients.
Before the world’s leading single-cell light guide system Beacon, researchers are screening cell lines, automated single-cell sorting, culturing, and detection functions , can achieve efficient, rapid and accurate cell line screening, not only can fully ensure the monoclonal origin and high expression of cell lines, but also greatly improve the overall drug development efficiency.
In the quality research department, analysts scientifically and meticulously study the physical, chemical, biological, and immunological properties of drugs. Multi-level research results, comprehensive and rigorous design quality standards and protocols, and careful investigation of the stability characteristics of drugs under various conditions.
A project will be applied for listing this year. The application time is tight and the analysis and testing tasks are heavy. The researchers completed the instrument maintenance and analysis in a very short time. Method confirmation and other work, with high R&D fighting spirit and rigorous work attitude, lay the foundation for the smooth application of the project.
The lyophilization process of biological drugs is relatively complicated, and the routine research and development cycle is long. Researchers use advanced intelligent freeze-drying systems to “tailor-made” the design and optimization of freeze-drying processes for different products, efficiently interpret freeze-drying curve parameters, quickly obtain the most suitable process for product scale-up, and greatly promote the formulation of the project R&D progress.
Among the mountains of materials, the registrar is repeatedly checking and proofreading the application materials, and preparing the answer sheet of “Declaration Materials”. Registration is the last step in drug research and development, and the submission of the marketing application is the most intense “rush test”. On the basis of rigor and meticulousness, it is the only way to complete more compliant, scientific, and high-quality registration application materials as quickly as possible. Target.
The inspectors in the energy power room are checking the operation of the equipment item by item. By comparing the data To determine whether the equipment is running normally. At the same time, we conduct hidden danger investigations for each key point to ensure that the equipment and facilities are 100% operating normally, providing a steady stream of surging power for R&D.