Webinar 3: Filtration and separation challenges: Scale up, scale down
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Summary
Date: Wednesday May 22, 2024 Time: 11 am CEST / 10 am BST
Speakers: Lynne Deakin and Ana Martinez
Event language: English
Looking for an alternative time? Click here to register for the Americas session at 2 pm EST (8 pm CEST)
The School of Purification continues with “Webinar 3: Filtration and separation challenges: Scale up, scale down."
Development of biotherapeutics requires parallel activities – determining the clinical efficacy of the therapeutic whilst establishing the manufacturing process by which it will be made.Once the manufacturing process is established, validated and registered with regulatory authorities it is very difficult to change and for good reason as changes could affect the quality of the therapeutic and therefore its efficacy and effect on patient.
In the initial stages of process development, little can be known about the efficacy of the biotherapeutic, so the techniques used to make material of the desired quality for clinical trials, must be representative of the intended large-scale process.
Scale down tools enable rapid process development and have advanced significantly in the last decade. However, there are still some areas that prove challenging as there are limitations that impact the characteristics of the process step in terms of equipment geometries, flow characteristics and quality attributes. Here we discuss some of these limitations of scaling and look at advances in technologies that help to bridge the gap enabling rapid development of new biotherapeutics and the ability to trouble shoot commercial manufacturing issues should they arise.
Meet the presenters:
Lynne Deakin is an Application Engineering Specialist focused on Life Sciences at Solventum (formerly 3M Health Care) EMEA with 25 years of experience in purification and separation technologies. She has recently been focused on improving process efficiencies through implementation of emerging technologies for clinical and commercial programs that drive simplification and increase yield. Lynne has collaborated with manufacturers of therapeutic proteins from discovery to commercial manufacture and supported numerous global transfer programmes. She has also lead a number of research collaborations and co-authored a number of publications in biotherapeutics. Lynne holds a BSc in Biochemisty from Sunderland Univeristy and participated in the MBI program at University Colledge London (UCL).
Dr. Ana Martinez is an Advanced Bioprocess Applications Specialist for Solventum Purification and Filtration Business. Ana has a decade of experience providing technical support and application advice to customers globally in a variety of filtration areas. Ana has also been involved in the development of several filtration technologies. Ana obtained her PhD at the University of Illinois at Urbana-Champaign. Her doctoral research focused on the development of novel reverse osmosis membranes with dendrimeric polymers for enhanced performance.
Solventum School of Purification
The School of Purification is a program designed by a team of Solventum Technical Experts, with the purpose of educating the industry on a range of important biopharmaceutical separation and purification topics through a series of interactive and engaging webinars. To learn more about the School of Purification and to view all previous webinars On-Demand, visit our website: School of Purification (3m.com)
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