We are excited to announce that Nelson Labs will speak at the premier edition of the Informa Markets ‘Extractables & Leachables Virtual Forum’, on september 2-3, 2020. Due to the global spread of the SARS-COV-2 virus, Informa Markets is organizing a Live Virtual Forum on the importance of the studies of Extractable and Leachable substances. When making Parenteral Drug Products, pharmaceutical companies have need to further investigate the materials that will be in contact with the drug product, either during manufacturing, intermediate storage, storage in its final packaging, or during the delivery of the drug to the patient. While historically, the potential safety issues were the main driver in these kinds of investigations, recently, also quality issues – i.e. for biopharmaceuticals – have become an additional concern.
During this first edition, our Head Study Director Anja Cerstiaens, PhD, will represent Nelson Labs. She will give a presentation on Thursday 3 September, 13:45-14:05 (CEST). Here she will talk about the following subject:
A Modular Approach Towards Generation of Leachable Data to Support Regulatory Filings:
- Ways for setting up a leachable study
- Identifying challenges with known and unknown extractable data for identifying potential leachable compounds
- Risk assessment strategy with identification of better method development and validation process
- Discovering targeted & non-targeted leachable screening and stop limits
- Crafting stability plan for leachable studies
We look forward to meeting you (virtually) during this two-day conference. Register via the link below. Registration costs 500 USD per delegate.