We are happy to announce that Nelson Labs will be exhibiting at The Pharma Days 2024 tradeshow in Geneva, Switzerland June 5 & 6.
We will have consultants available to answer any testing and compliance questions. Come visit us at booth E16!
Our Senior E&L expert, Sona Kovackova, will give a presentation:
Extractables & Leachables Qualification of the Primary packaging for Biological Products
Presenter: Sona Kovackova PhD, Senior E&L expert – Nelson Labs
In 2022, the final recommendations of the Product Quality Research Institute were published for Parenteral Drug Products. Apart from the wealth of information and considerations on design of extractable & leachable studies for parenteral drug products in general, it also contains valuable information on specific considerations for biological products. For biological products, not only the safety but also the quality of the product and related concerns about immunogenicity and leachables reactivity come into play. We will give an overview on the recommendations and how it affects the design of an extractable & leachable study for the primary packaging of biologics.
Register now: https://www.thepharmadays.com/registration-info
For more information and the programme click here.
