Duxact Team | Bring you close to the excellent project teams at the Analysis and Testing Center
Source:DUZHENG Release date:2019-04-01
The consistency evaluation of the quality and efficacy of generic drugs includes recruitment of subjects, clinical trials, biological sample analysis, and data management & statistical analysis. All stages are linked with one another closely. Only when every link performs with high quality and efficiency can a project be completed perfectly. It is the Duxact Analysis and Testing Center that has undertaken the core task of biological sample analysis.
▲ Duxact Analysis and Testing Center
It mainly carries out scientific research innovation, method development, biological analysis and testing, committed to building an international, standardized platform for biological analysis and research.
As of November 2018, it has completed more than 40 BE projects, and had more than 100 LC-MS/MS methods with completed methodological verifications. At present, it has become a testing platform with “the largest scale, the most advanced hardware, the most standardized management, and the strongest analytical ability in the region.”
Recently, four project teams at the Analysis and Testing Center realized the failure-free analysis of batch during the trial, and the consistency of incurred sample reanalysis (ISR) reached 100%. How could they do it?
In this issue, the editor will bring you close to the four “zero defect” project teams at the Center. Let us listen to their stories.
Project Team 1
Keywords: The harder one works, the more fortunate he will be.
Editor: How long has your project team been established?
Qiqi: It is less than three months since its establishment, and two projects are currently underway.
Editor: Is your work pressure heavy?
Liang Qi: Yes, but I am fulfilled, and I feel that I am getting better and better.
Editor: What do you think is the most important thing during the trial?
Liang Qi: The ability to analyze and solve problems independently. The analysis test generally comprises two stages of method development and sample analysis. Different samples should use different test methods. The problems must be analyzed as the case may be. This requires our experimenters to have the ability to independently analyze and design methods.
Editor: How do you make sure the trial is perfect?
Liang Qi: Keep exploring and work hard every day!
Project Team 2
Keywords: Make concerted efforts; share the work and cooperate with one another
Editor: How many projects are you currently undertaking?
Editor: How did you achieve zero error in completion of the project?
Cao: It mainly depended on the high efficiency and quality of the team. Our experimental process was complicated while time was tight, so the three of us had a clear division of labor and maintained efficient communication!
Editor: What impressed you the most?
Cao: The more important the trial was, the more nervous we would be. But when a group of key data came out, we would be particularly excited, very happy, and feel that no pains, no gains.
Project Team 3
Keywords: Responsibility; trust
Editor: Is this the first time you have led a team?
Rong: Yes, our team has been established for only three months.
Editor: Have you encountered any difficulties during the trial?
Rong: The main difficulty was to ensure the experimental progress while making the team members familiar with each other as soon as possible. Our team is mainly composed of newcomers and their ability to independently analyze and solve problems needs to be developed.
Editor: How did you solve these problems?
Rong: Everyone is very responsible and tries their best to ensure the completion of the trial. In the process, we encountered many difficulties, but we trusted each other. So we really felt relieved in our hearts and reassured.
Project Team 4
Keywords: Keep respectful and be cautious
Editor: I heard that no other domestic platforms have made success in the trial you have just completed!
Ouyang Zhonghua: No other platforms have passed the national verification. This variety is greatly influenced by factors in vivo. In order to make success, in addition to the high quality of the drug itself, high-quality clinical trial design and control are needed. Our company has established clinical trial centers with a number of hospitals, and has abundant clinical resources, which provide reliable guarantees for the trials.
Editor: What are the specific guarantees?
Ouyang Zhonghua: We have arranged the layout based on the entire industry chain at the very beginning, which has given us advantages in clinical collaboration with hospitals, thus ensuring the effective implementation of clinical trial protocols. Secondly, we have a comprehensive information management system for samples, which has greatly reduced man-made errors. In terms of sample analysis and testing, we have built up an analysis and testing platform with Waters Corporation, and we have world-class instruments and equipment as well as an analysis and testing team to ensure the authenticity and reliability of the test data. Finally, we also have our own data management and biometric team, thus providing “one-stop” services for the consistency evaluation of generic drugs.
Editor: What have you learned from the trials?
Ouyang Zhonghua: Be respectful, bold but cautious. We are engaged in a sacred cause. The quality of drugs is related to the national economy and the people’s livelihood. We can't be careless. If mistakes were made, there might be a possibility that poor quality drugs would enter into the market. We must be bold but cautious with our experiments, constantly making improvement and innovation. We shouldn't follow the old routine. We should pay attention to details, and do everything well.
Through communication with the project teams at the Analysis and Testing Center, the Editor saw the responsibility and initiative that a good team should have. We will continue to maintain and carry forward this spirit of innovation and truth-seeking, and never stop exploring!