Bridging Bench to Bedside: De‑Risking Biotherapeutic Administration via CDMO‑Led Clinical‑Mimic and In‑Use Testing Strategies, Upcoming Webinar Hosted by Xtalks

In this free webinar, learn what clinical in-use studies are and why they matter for biologics safety, efficacy and CMC lifecycle. Attendees will gain insight into designing clinical in-use studies and primary considerations. The featured speakers will discuss analytical method selection for the assessment of critical quality attributes. The speakers will also share compatibility and device considerations (e.g., diluents, IV lines, filters, syringes and infusion bags). Attendees will learn about translating results into labelling, pharmacy SOPs and risk versus benefit decisions.

TORONTO, Jan. 7, 2026 /PRNewswire/ — As biotherapeutics leave the controlled environment of the manufacturing facility and enter real-world clinical trials, the risk of failure due to lack of efficacy could be as high as 50%. This can be de-risked by evaluating how stressors during preparation and administration may affect therapy, using clinical in-use studies during drug product process development.

This webinar explores how clinical mimic studies sit at the intersection of stability, compatibility, handling and patient safety. The featured speakers will focus on the risks of aggregation, adsorption, subvisible particles and functional loss and will introduce considerations that accompany reconstitution, dilution and storage. Real case examples will be presented to highlight common failure modes and mitigation strategies to enable safe and efficient clinical use.

Participants will learn approaches to design robust, fit-for-purpose clinical in-use protocols aligned with evolving regulatory expectations (WHO, FDA, EMA and USP), selection of appropriate physicochemical and biophysical analytical methods and interpretation of data to support decision making and risk management with respect to clinical administration of biotherapeutic drug products.

Register for this webinar to learn how clinical in-use studies contribute to clinical trial success by strengthening the safety, efficacy and reliability of biotherapeutic drug administration.

Join experts from FUJIFILM Biotechnologies, Daniel Pettit, Head of Analytical Development; and Natalia Harasimiuk, Director of Analytical Services, for the live webinar on Thursday, January 22, 2026, at 10am EST (4pm CET/EU-Central).

For more information, or to register for this event, visit Bridging Bench to Bedside: De‑Risking Biotherapeutic Administration via CDMO‑Led Clinical‑Mimic and In‑Use Testing Strategies.

ABOUT XTALKS

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Contact:
Vera Kovacevic
Tel: +1 (416) 977-6555 x371
Email: [email protected]

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