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Editor's note:
In the past year, all employees of Patronus have been working together with a strong spirit, challenging one after another seemingly impossible tasks, and proving to us with practical results that impossible is nothing. This month we are pleasured to invite three representatives from Patronus, they will share with us the story of Patronus with their own experiences.
Manufacturing Director Li Yuliang/Quality Control Specialist Song Gaoquan/Analytical Research Department Researcher Li Yan
Q: Hello and thank you for taking the employee interview of February Issue, to start with, please give us a brief introduction of yourself.
Li: Hello everyone, my name is Li Yuliang, Manufacturing Director of Patronus Biotech, I have joined Luye for 15+ years. I have been engaged in the production management of sterile pharmaceuticals for about 13 years. I have participated in many GMP site inspections and FDA PAI site inspections of projects in China. In the meantime, I have also participated in the construction of injection workshop, industrial park, microsphere workshop and commercial workshop of Patronus.
Song: My name is Song Gaoquan from QC. I was transferred from Boan to Patronus in September 2020, so I am the earliest employee who joined Patronus, and I have been working in QC for almost 6 years.
Yan: I am Li Yan, an analyst researcher in Patronus 's Analytical Research Department. I joined the company in June 2021, and it has been almost 8 months since. I graduated from Changchun Institute of Biological Products with a degree in Immunology. I have one year of GMP work experience and three years of reagent kit development experience, including method development and validation, as well as preparation lyophilization, and I have also worked on cell expression. After joining Patronus, I was mainly responsible for the development and validation of active methods and transfer.
Q: As we know, Patronus is a newly established company, and we know the beginning is always the most difficult part. How did you feel when you start to work on this project at the very beginning?
Song: I was very happy and proud to be a part of the project team when the company decided to start the development of the COVID-19 vaccine in view of the severe epidemic at that time. On the one hand, I was very happy to be able to work in a new company where I could enjoy and take advantage of my strengths. On the other hand, I feel very proud indeed that the vaccine project I was involved in might benefit the world.
Li: I joined Patronus in July last year, and at that time, I had already known about the company's vaccine project. I had mixed feelings at first, reluctant and also perturbed. I do have experience in project construction, but I’m totally new in molecular manufacturing. The company's trust in me by allowing me to participate in such an important project made me feel that I have to make this work. Seeing that colleagues from different sub-companies have also joined this new company made me feel confident.
Yan: At first, there are two words that can express my feelings: lucky and apprehensive. I felt lucky that I met good leaders, good technical platform and a development platform. In fact, I felt deeply about this during the interview, and after I joined the company, I kept deepening and firming up my thoughts.
I was apprehensive for two reasons: although Luye is a big company with long history, Patronus is still a young company, our technology is new with no competitors in the same filed in China, and only several oversea companies which are still in the clinical stage. We need to spend much time and effort, so that we can bring this product to the market. I was also not so sure about myself since I’m new to this company, I was worried that I’m not competent enough for this job and hold the team back. However, time has proved that Patronus is getting stronger and stronger in spite of all the difficulties, and I was also growing.
Q: It has been a while since you joined Patronus, when you look back what you have been through, do you feel any changes deep inside?
Li: It has been half a year since I joined Patronus in July, we have been working on one task after another nonstop. First we worked on the manufacturing and filling of clinical samples, which was a very important and urgent task. The entire project plan is scheduled without a day's time error, allowing only success and not failure, without any possibility of error. We have also worked on QP audit of the quality system of the pilot-scale workshop, which was also quite challenging.
The second task was the construction of the commercial workshop, we spent three months to start from scratch. We started pilot production of engineering batch on December 1st. And another month for manufacturing license application and on-site inspection. I am very touched by our colleagues’ great efforts and fighting spirit. We have also received support from other companies like Shandong Luye and Boan Biotech. The fact that we have finished workshop construction and obtained manufacturing license proved that we have the potential to come from behind, and this strengthened our confidence in the project.
Song: My feeling changed a lot till now, I was happy and proud at first, but once we started to work, we encountered many difficulties, and now we feel a heavy sense of responsibility, especially for some of the quality research work made us feel that there is still a long way to go, we have a lot of work to do and we can't afford to be sloppy.
Yan: I think I have made the right choice and I always feel lucky. My supervisors are professional with great strategic sense. My colleagues are also professional and result-oriented. We are all united as one, when you are in such environment unconsciously will become very positive and powerful.
For the LYB001 project we need to keep facing the difficulties, we do have a lot of challenges in terms of project schedule, process technology, analytical method, quality research, etc. But everyone around us never runs away, we all face the difficulties and solve the problems actively, I think this atmosphere is very good.
Q: You have all mentioned about all the difficulties in this project and it is good to hear that everyone is positive about it, can you share with us the biggest challenge during the project?
Li: Everything is challenging, for example clinical sample manufacturing. Since we have confirmed the clinical study timeline, therefore the timeline of all the other work have to be calculated backward accordingly, which allows no mistakes in the entire manufacturing process.
Speaking of the commercial workshop construction which only took us three months to finish. The company gave us the task to make sure the workshop is ready for engineering batch production by December 1st, which means it is not simply finish the construction work and move in all the machines. We have a lot work to do to meet this requirement, including building up document and quality system, machine debugging, staff training and others. During that time, we have 650 files on hand to build up a quality system, 200+ machines were waiting to be validates. It was a huge challenge to us in just three months with just 6 people in the team, even when we started manufacturing, there were only 21 colleagues.
Opening ceremony of Patronus commercial workshop filmed on December 1st
Government officials and guests visiting the new vaccine workshop
I still remember clearly about the manufacturing license, when I was having lunch with Ms. Xue on December 5th, she said we have to finish on-site inspection of the manufacturing license before the New Year, which means there was only half a month left for me. We hadn't even completed the equipment procurement process yet; it was a mission impossible to me. I started to work with Luan Jipeng from procurement on solutions, Mr. Lv Daomin from Engineering Department was also involved. What he said to me really boost my confidence, he said: “Don’t worry, tell me what to do, and we will make every effort to make it work.”. We started to communicate and negotiate with vendors, and finished equipment manufacturing and installations. In the end we not only completed the mission, but we even finished ahead of schedule, which is truly incredible. The whole process was hard, but I felt happy and fulfilled.
Song: It was the same to us, our department also had to face the challenges posed by the project schedule. The pressure on the entire project schedule was indeed very high. From the beginning of this project, I was the only person in the quality department from September to December, and since 2021 we have formed a team of 4 people transferred from various platforms. We had nothing in the lab at first, no equipment, no machines, no documents, no management system. We have to write documents from scratch, procure equipment to build up the lab, and finally we have everything all set. In the meantime, we attended trainings to learn and improve our knowledge, and finished QP audit in the end of September, we gained a lot from all these efforts.
Yan: The biggest challenge to our department was to build new method. Innovation is our achievement but also a challenge. LYB001 used new technology, with no reference in domestic market and only few similar projects oversea but still at clinical stage. We have to do loads of work, provide a lot of data to prove our technology.
For example, we need to establish activity test method for this project, but there is absolutely no vaccine of the same type to refer to, even the national standard issued for the COVID-19 vaccine is not applicable to us, so we have to develop a completely new method by ourselves and to get the approval of the authority. We need to keep communicating with the authority and adding data in the process of communication to gradually gain their trust.
Q: You have all talked about the importance of teamwork, what are the important factors of a successful teamwork?
Li: The collaboration is not limited to internal departments, we have also received support from Shandong Luye, Boan Biotech and other sub companies in the process of workshop construction and manufacturing license application. Good collaboration is the foundation and key to a successful project. No one or no department can complete a project on their own. As Gaoquan has mentioned, there were only 4 people in their department at first. Now we feel there are no clear boundaries among department within Patronus, we don’t mind which task should be finished by any specific department. We care about the deadline and who is capable to do the work. Any capable colleague is willing to take the responsibility actively with no hesitation, this shows a close collaboration within Patronus.
Patronus commercial vaccine manufacturing workshop
Song: I agree, we share the same goal and we are all making efforts toward the same goal. We are more like one family, making no distinction between “you” and “me”. I also believe this is because we all share the same sense of identity to the company.
Yan: I agree with both of you. First, we share the same goal; second, we have to accept our own weakness, put myself into the team and find my position. But also I have to identify my strength and use it in cross-department collaboration, because it is always about effective communication. We need to fully utilize our expertise to make sure others are at the same page with you and prevent from any mislead from the target during communication.
I think unity is the basis of success in all endeavors. As a child, we all learned the saying: "All hearts are united to move mountains", which is not only the pursuit of a company, but our whole country is in pursuit of the power of unity. Only if you know how to work together, you can break through the limitations of the individual, the department can break through the limitations of the department, and give full play to the role of collective collaboration to produce the effect of 1+1>2, and ultimately to success.
Q: The younger generation is an important force for the company’s future development, as one of the younger generation, what is the most valuable characteristics of young people?
Li: Young people are young, daring, impulsive, passionate, courageous, and they are more energetic with sufficient learning ability, strong execution and action.
Song: Young people are more innovative, which is something that Luye values. Innovation creates future. The vaccine project we are working on is an innovative project, which requires more novel analytical methods.
Yan: I share the same view with Mr. Li and Gaoquan, I think the most shining traits of young people is pioneering, innovative, and enterprising.
Q: What is your expectation of this project?
Li: LYB001 is a new project, and we are a late comer in the field of vaccine. This project is racing with the time and COVID-19. I hope we can finish all tasks on time according to the timeline, I also hope that all the other vaccine products will go well in the future and contribute to human health.
Song: Yes, hope this product can be launched successfully and our samples can pass inspection.
Yan: LYB001 project is the first vaccine product of Patronus, and we are looking forward to the breakthrough of this vaccine and its successful launch, so as to open a fast channel for the launch of our subsequent products of similar technology, and strive to open the door to success.