Stable by Design: How Lyophilized Reference Drugs are Changing Biologics Development
Clinical-grade reference products are indispensable in biologics research — from bioassay validation to comparability studies and biosimilar development. But dependence on frozen liquid formats comes with real constraints: cold-chain logistics, temperature-sensitive shipping, and tight expiry windows that limit how and where these materials can be used.
In this webinar, we'll introduce our new lyophilized clinical-grade reference products and share the data behind them.
You'll get an overview of our reference drug portfolio and how it supports your research, followed by a look at the analytical work we conducted across six approved biologics — including mAbs, a fusion protein, a cytokine, and an ADC — comparing lyophilized and frozen liquid formats across structural integrity, purity, and bioactivity.
The results may surprise you: no meaningful difference in quality, but significantly more flexibility in how you store, ship, and use your reference standards.
You'll leave with a clearer picture of:
How lyophilized reference products hold up against their frozen counterparts
What this means for your lab's workflow, storage setup, and shipping costs
Whether a dual-format approach could work for your specific research needs
The session closes with a live Q&A — bring your questions.
ABOUT THE SPEAKERS
Dr. Christian Schmitz, MBA is the Founder and CEO of Evidentic GmbH, a company he established to solve one of drug research's most persistent challenges: access to licensed molecules. Holding a PhD in Biology from York University and an MBA from HHL Leipzig, he brings over a decade of experience across biopharmaceutical companies in the US and Germany. Under his leadership, Evidentic has grown to serve more than 550 customers worldwide, delivering EMA/FDA-certified medicines to accelerate R&D and advance global health.
Diana Schmidt is a biologist (M.Sc.) specializing in cell and molecular biology with a strong background in biotechnology. She has extensive experience in pharmaceutical quality control, ensuring compliance with EU-GMP guidelines and regulatory standards. Her scientific work includes several years in stem cell research at the University Hospital Erlangen, focusing on iPSC-based cellular models. Her expertise lies at the interface of biotechnology, cell biology, and pharmaceutical quality, with particular relevance to advanced therapeutic products. She's led the Evidentic Lab since she joined the team in 2024.
Please note: The session will be recorded. By signing up for the webinar, you agree to receive e-mail communication from Evidentic and will be given the opportunity to unsubscribe at any time.