Similar to other developing countries, the quality of Chinese bioproduction is often questioned by international markets due to various outbreak of scandals related to breach of quality protocols in production process. We invited Dr Amy Que, Vice President of Quality Control of Innovent Biologics, one of the leading innovation-driven biotech companies emphasizing on quality production to speak at the 10th BioPharma Asia Convention, Singapore next 21-23 March in hope to leverage on her expertise to share a light on the status of biomanufacturing in China.
Prior to her joining us at the conference, we were happy to get the chance to ask Dr Que several questions below to give you a brief overview on what you can expect from her presentation on “Ensuring excellent production quality of emerging therapeutic products” .
Q: What is the state of biomanufacturing in China compare to the past?
Que: Biomanufacturing in China has been evolving due to increasing demand in the following areas:
(a) More domestic and global companies are interested and invested in Biopharmaceutical R&D in China, which requires biomanufacturing for process development, drug development in preclinical and in clinical phases, and the preparation of commercialization.
(b) More global Biopharmaceutical companies outsourcing their process development and clinical material manufacture in China.
(c) More global Biopharmaceutical companies are interested in developing drugs and marketing in China.
Q: How can quality of Chinese biomanufacturing be improved to regain industry confidence?
Que: Quality of Chinese Biomanufacturing can be improved to regain industry confidence through following areas:
(a) Continuous improvement, gaining visibility and influence of cFDA in global regulatory area.
(b) Education and enforcement of cFDA and other regulatory agencies.
(c) Enforcing Quality System always in company, manufacture, and laboratories, including enforcing GMP and GDP concepts and execution; compliance, data traceability and date integrity in Bio manufacturing.
Q: What is the impact of Chinese government latest regulatory reform on pharma sector?
(a) Create a better environment for Biopharmaceutical industrial.
(b) Help to speed up the review process and timeline
(c) Promote the companies that follow and have confidence in meeting quality and compliance in their process development, manufacture, and clinical studies.
Q: What encouraged you to return to your homeland after decades working in US?
Que: The demand in Biotech industrial in China including the demand of affordable drugs for Chinese patients, and the commitment that Chinese government and biotech industrial scientists make in developing local Biotech industrial.
Q: Based on your experience working in pharma MNC (Pfizer, Wuxi) and domestic pharma companies (Innovent, Sino), how can Chinese pharma companies be more innovative in their manufacturing?
Que: Chinese pharma companies can be more innovative in their manufacturing through following areas:
(a) Be more innovative in Process Development to target an efficient and robustness process with higher production yield and lower cost, and to be more manufacture-fit.
(b) Be more innovative in the design, operation, and maintenance of manufacturing facility. The goal is to achieve efficient and consistent production with low failure rate and low operation cost.
(c) It is a process of learning, evaluating, practicing, listening and improving. As Chinese government makes more commitments in developing Biopharmaceutical in China, more companies are dedicated in making manufacturing more and more innovative in order to manufacture high quality drugs affordable to Chinese patients.
Want to find out more? Join us at the 10th BioPharma Asia Convention 2017, Singapore next 21-23 March to hear from more than 150 speakers and meet with over 1500 industry stakeholders. Book now to save more.