Particulate matter is a leading cause of drug product recalls and poses risks to patient health. Therefore, particulate control is paramount in pharmaceutical development and is a persistent challenge across product lifecycles. Effective management of particulate contamination is crucial for safeguarding patients and avoiding costly and time-consuming issues for manufacturers.
In this webinar, the speakers will explore advanced analytical methods for characterizing and controlling particles. From development to commercial manufacturing, the attendees will get to learn how to safeguard products and patients. They will discuss particulate matter characterization and control, including regulatory guidance and cutting-edge analytical methods to quantify particles even in the micron range. They will also dive into case studies and learn how to approach particularly challenging cases, such as difficult-to-inspect parenteral preparations and orally inhaled and nasal drug products (OINDPs).
Register for this webinar today to gain insights into advanced analytical methods, including regulatory guidance, for particulate control.
Speakers
Eva Rödel, Principal Scientist Characterization, Solvias
Eva studied Chemistry and received her Diploma in Crystallography (Freie Univ. Berlin). During her PhD, she focused on structure-activity correlations in heterogeneous catalysis (Fritz-Haber Institute of the Max Planck Society). During her Post-doc, she focused on spectroscopy with Prof. A. Baiker (Chemical and Bioengineering) at ETH Zurich. In 2008, she joined Solvias as a Project Leader in Polymorphism Screening. She later changed her field to Biopharmaceuticals and then spent a few years at Roche in Particle and Formulation Characterization. In 2019, she came back to Solvias as a Team Leader in Specialized Analytics, and then in 2023 became the Principal Scientist Characterization.
Message Presenter
Aline Schmidlin, Senior Scientist Particulate Matter Characterization, Solvias
Aline earned her French-German Bachelor’s degree “Regio Chemica” in Chemistry before continuing her education with a Master’s degree in Chemistry at the chemical engineering school ENSCMu in Mulhouse, France. Commencing her professional journey in 2018 at Solvias as a Scientist focusing on Physical Characterization, she has specialized in the field of Foreign Particle Characterization. Since 2023 she is working as a Senior Scientist primarily in Particulate Matter Characterization and is supporting customer investigations by characterizing foreign particles/contaminants in pharmaceutical products using various analytical methods.
Message PresenterWho Should Attend?
This webinar will appeal to those working in pharma or biotech or those focused on drug development in the form of injectables (parenterals), biopharmaceuticals, vaccines or OINDPs, as well as the following:
- Head/Director/Manager Analytical Chemistry/Analytical Science and Technology/AS&T
- Head/Director/Manager Manufacturing Science and Technology (MSAT)
- Head/Director/Manager of CMC
- Head/Manager of Operations/Manufacturing
- Head/Director/Manager of QC/QA
- Process Expert/Head/Manager Visual Inspection
- Purchasing
What You Will Learn
- Navigate through a spectrum of cutting-edge technologies and tools that should be used for characterization, development and quality control
- Explore the latest regulatory guidance for controlling particulate matter in drug products
- Learn strategies to overcome challenging cases such as parenteral preparations and orally inhaled and nasal drug products
Xtalks Partner
Solvias
Solvias helps innovative companies advance their path to commercialization with CMC analytical solutions powered by deep scientific expertise and a relentless focus on our customers’ success. With years of expertise in small molecules, biologics and cell and gene therapies, our talented subject matter experts have the know-how, creativity, and tenacity to solve even the most complex analytical challenges. Solvias offers comprehensive solutions from raw materials to drug products to final release testing as well as API development and manufacturing for small molecules. Customers have a single, trusted analytical partner for their entire development journey. Our five global facilities are strategically placed in biopharmaceutical hubs. We are GMP, GLP and ISO certified and conduct over 100 successful customer audits every year. We take pride in putting science and quality at the heart of everything we do, helping our customers bring better and safer products to market faster.
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