“I look forward to seeing that innovative drugs developed and produced by Laekna will help patients around the world.”
Q1 What is CMC?
A: CMC stands for Chemistry Manufacturing and Control. We oversee process/formulation research and development, process scale-up, manufacturing, and quality research and control of APIs/dosages and preparations.
One of our tasks is to work with the clinical team to deliver test drugs to subjects participating in clinical trials. Should the drugs be made in tablets or capsules? What specifications are needed to support early-phase dose-escalation studies? ... On this basis, we will conduct wide research on formulation and preparation process in order to provide high-quality medicines for the subjects.
Q2 What are the challenges in the position of quality research and control?
A: The industry generally believes that analysis serves as the “eyes” of process and formulation development. Our basic task every day is to generate and analyze large amounts of data. The challenge lies in how to ensure the reliability and accuracy of the data. We need to be careful enough to ensure experimental design and acceptance criteria so as to detect abnormal data in a timely manner.
Q3Why did you decide to join Laekna?
A: Because of trust.
At that time, someone recommended me for an interview at Laekna. I chatted with two founders, Dr. Chris Lu, Amy, and Dr. Feng Tao, head of CMC department. I felt great. Laekna is the kind of company that gives people a sense of trust. I previously worked with CDMO and MNC, and my qualifications are just right for an emerging but promising biotech like Laekna.
Q4: What’s your take on the prospects of the biopharma industry in general, especially the development of companies engaged in innovative drugs?
A: The once-overheated industry has returned to normalcy in the past two years, allowing people to identify companies that are truly devoted to R&D and innovation.
Laekna has a solid foundation and a down-to-earth style. We often hold meetings with Dr. Lu, who, as the company’s Chairman and CEO, is elaborative on different subjects and matters. Thanks to his expertise and exposure, everybody is confident that things we do at Laekna are bound to succeed.
Q5 What do you aspire to achieve at Laekna?
A: Laekna has planned to launch a new manufacturing base in line with cGMP standards in Shanghai’s Lingang New Area, with annual production capacity expected to reach 200 million doses. As someone working in the pharma industry, I look forward to seeing that innovative drugs developed by Laekna will come off the production line at our own manufacturing base to help patients in China and around the world.
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