Ahead of the upcoming Extractables & Leachables China 2020 conference, we caught up with Lei Zhang, Physicochemical Analysis Director at Shanghai Henlius Biotech. He gave us a sneak peek of what we can expect from his presentation on day one, taking place during our 'E&L in Single Use Systems' session.
Current Industry Focus:
Q. As consumers/end users continually push for more safer solutions, what do you think is the biggest concern regarding Extractables and Leachables?
Accurate Identification & quantification process is the biggest concern. Extractables and leachables can be extremely complex due to complicated formula of tested article and drug-material interaction; The analytical evaluation threshold of certain drug product can be fairly low, which place greater demands on chemical entities identification and quantification.
Q. What are some of the biggest opportunities gaining attention within the Extractables and Leachables field? How has your company chosen to react/adapt to stay on trend?
Regulatory authorities have implemented stringent guidelines, making it mandatory for drug developers and packaging material/single use system suppliers to closely monitor the levels of extractables and leachables.
Our company have collaborated with suppliers to collect background information and built up E&L platform to conduct in-house study.
Q. What industry topics are getting the most attention at this time? How are these factors influencing the future of pharmaceutical packaging/medical device materials?
Centralized procurement and biosimilars development make the price of drug product more lower. Pharmaceutical companies would focus on the cost performance SUS product purchased from packaging material/medical device suppliers to win the market share.
Q. What does your company/organization hope to achieve over the next 5 years with regards to the future of pharmaceutical (packaging)/medical device industry?
We hope to get a stable supply chain from pharmaceutical (packaging)/medical device industry.
Q. What opportunities are there for harmonization of pharmaceutical packaging/medical devices in the Asia Pacific region?
Biologics market (e.g., monoclonal antibody, bispecific antibody vaccine) is booming and pharmaceutical companies employ single use technology in commercial/pre-commercial manufacturing.
Q. What do you expect the future regulatory landscape of Extractables and Leachables in China is going to be?
Center for drug evaluation issued “Technical guideline for compatibility study of plastic system used in manufacturing of chemical drug injections (for trial implementation)” in 2020.
We expect more technique guidelines on E&L assessment of single use system and biologics. For instance, guideline on experimental procedure and risk assessment.