Interference of leachables with biopharmaceuticals during manufacturing, storage and administration
E&L examination is continuously growing in importance and given the current scrutiny paid by governing bodies including the FDA and MHRA, understanding the best practice and guidelines to carry out extractables and leachables studies is imperative in order to eliminate risk and potential development delays. Therefore, it is vital to look how leachables interfere with biopharmaceuticals during manufacturing, storage and administration.
The current trend within the biopharmaceutical industry is to apply single-use systems (SUS) for manufacturing of Biologics drug substance (DS) and drug product (DP), since there are several advantages over stainless steel equipment. A key factor to applying risk-based E&L assessments is the large amount of SUS employed in a complex manufacturing process for Biologics, especially when the main focus of the assessments is patient safety. However, the quality of biologics DS and DP can potentially be altered by compounds that are present far below safety thresholds.
At Extractables & Leachables Europe in November, Lukas Mogler, principal scientist and senior group leader for Lonza will be presenting a case study on ‘Interference of leachables with biopharmaceuticals’ to provide you within even more insights into this important topic. This case study examines when E&L compounds in trace analytical are detected in components and used for manufacturing, storage and administration of biologics DS and DP.
To hear more about the case study and to gain more insights on the interactions of E&L, jolin us at the E&L Europe 2023 on 6-7 November in Amsterdam. Other presentations during the Interactions of E&L session include:
- Leachables and biotech drug products: not only toxicity but also product quality-related concern | Daniele Zarini, Pharma Consultant, Eurofins Regulatory & Consultancy Services s.r.l.
- Case studies to demonstrate the susceptibility of ophthalmic drug products to the leachable compounds originated from the plastic packaging containers | Ramarao Gollapalli | Associate Director, R&D, Akron
With speakers from reputable companies like Element, GSK Vaccines, Aptar Pharma, Octapharma, Sartorius Stedim Biotech and numerous others, the agenda is bursting with insights, helping the conference be the most exceptional one to date. Find our more about the agenda here
Described by a previous attendee as 'the place to be for the E&L community', this is a mist-attend event for anyone working in the industry. Find out more and book here
In addition to organising the renowned E&L events in Europe, US and China, Smithers also have a long history in providing E&L and medical device testing across the globe. Find out more at www.smithers.com.