Q1 You have rich experience in biopharmaceutical industry. Would you please share your academic background and working experience with us?
I was born and grew up in Shanghai. Thirty years ago, I went abroad to continue my study and to see the world outside after graduating from the university. Fortunately, during the past thirty years, I have witnessed the golden age of rapid development of the biopharmaceutical industry from the very early stage, and I had the opportunity to participate in different stage of the whole life-cycle process of the development of biological drugs. I have accumulated extensive experience in the process development, process scale-up, plant design and commercial manufacturing. Based on my industry experience, people with development and engineering background attains the process acumen, draws the connections between manufacturing unit operations, technical parameters, quality attributes as well as their impact on the entire product development life cycle.
Q2 Would you like to share with us the main reasons for you to join Henlius?
I have known Scott, the company’s co-founder for a while and always admired his passion and persistence. Last year, my daughter graduated from high school， giving me an opportunity to come to Henlius and spent two week interact with the team . During that time, I felt everyone’s passion and dedication to the work and was impressed by their strong work ethics, tenacity and urge for guidance to find the right solution. Therefore, I decided to join this team and bring the knowledge and experience gained over the last thirty years, make my fair share of contribution to the development of Chinese biopharmaceutical industry.
Q3 As the person in charge of Henlius’ manufacturing and engineering, would you like to share with us the major responsibilities of these 2 parts?
Manufacturing and engineering are inseparable. Given the advantage of Henlius’ diverse and advanced product portfolio, strategic and rational design and planning of the production scale, site, campaign and filing logistics is paramount. When the company was at the early stage, the main focuses were around research & development, clinical trial and regulatory submission. As the company transition from research & development stage to the commercialization, we need to better forecast market’s demand of the products, optimize the regulatory filling timeline of products and strengthen the plan and build of the manufacturing capacity. It normally takes about 4-5 years to complete the construction of the manufacturing facility, obtain product approval and eventually launch commercial production, meaning that we need to forecast the manufacturing plan 4-5 years ahead to leave enough time plan and build the manufacturing facility.
Q4 In 2019, Henlius has successfully launched our first commercial product. With market launch of more pipeline products and the expansion of the company’s global footprints, could you share with us the following manufacturing planning of Henlius？
In preparation of rising market demand of 汉利康 and the anticipated approval HLX02, our foremost task is to improve the company’s manufacturing capacity. With the support of the entire team, people with different expertise from all departments, we have taken a series of measures to expand the manufacturing capacity, this include mindset and organizational change, talent recruitment, training and adopt new technology etc. At the commercialized large-scale manufacturing stage, we need to focus on building data-driven mindset to speak with data.With the right test, deviation control, lean manufacturing, supply chain optimization and reducing waste, we can control the cost fundamentally to ensure the high quality and accessibility of our products.
Q5 Recently we received the good news that the company was officially granted 2 EU GMP certificates from the Chief Pharmaceutical Inspector of Poland. What does this mean to the manufacturing work of Henlius?
Henlius has always put the quality and patient first as the guiding principles of work which has become part of the company’s culture. I still remember the very first week that I joined Henlius is the week EMA conducting on-site inspection for HLX02. I threw myself into work as quickly as I could. The successful passing of EMA's on-site inspection and obtaining the European Union's GMP certificate is a great recognition and milestone of the company's quality system and manufacturing operation. I could not be happier about this accomplishment.
Q6 What are your expectations of the future work and yourself? And what is your expectation of the department from long-term perspective?
I would like to continue the expansion of Henlius’ manufacturing capacity, making strategic plans for the future in order to meet the growing market demands as well as maintain our cost competitiveness. Our product will benefit patients not only in China but also globally. To achieve this, we will further optimize the team structure, introduce the concept of large-scale production and optimal mode of commercial manufacturing, and improve the technical capabilities of the engineering department. Attracting new talents to join Henlius will bring in new idea and spark innovations.