#Canada #Toronto #Cell Therapies #Xtalks #CMC Strategies

Advancing Cell Therapies Webinar Overview

In the world of biotechnology, the transition from Investigational New Drug (IND) to Biologics License Application (BLA) marking is a critical phase for cellular therapies. To navigate this complex journey, Xtalks will be hosting a comprehensive webinar on September 30, 2025, focused on scalable Quality by Design (QbD) strategies in Chemistry, Manufacturing, and Controls (CMC) development.

Importance of CMC in Cell Therapy

Chemistry, Manufacturing, and Controls (CMC) play an essential role in the successful development of cell therapies. It safeguards the product's quality, consistency, and effectiveness throughout all phases of clinical trials and eventual market release. Participants will learn how to effectively leverage CMC insights to enhance their IND submissions and amplify the likelihood of BLA approval.

What You Will Learn

The webinar will offer participants unique insights into:

• - CMC Development Approaches: Understand how current advancements can streamline the IND submission process.
• - Building Robust Processes: Learn strategies to enhance the robustness of late-stage processes and analytical panels crucial for cell therapies.
• - Commercialization Pathways: Discover how to transition smoothly from IND to BLA while ensuring compliance with regulatory standards.

The featured speakers include industry experts such as Bruce Thompson, PhD, Chief Technology Officer of Kincell Bio, and Stewart McNaull, PhD, Chief Commercial Officer. They possess extensive hands-on experience, particularly in developing CAR-T products over the past five years, paving the way for a fruitful discussion on scalable, compliant pathways to commercialization.

Why Attend?

Engaging in this webinar is beneficial for researchers, developers, and investors who are involved in or curious about the landscape of cell therapies. As more companies work to bring innovative treatments to market swiftly, understanding CMC becomes increasingly relevant. The knowledge shared in this session will empower attendees to cultivate an effective CMC strategy that aligns with their goals.

Event Details

• - Date: September 30, 2025
• - Time: 11:00 AM EDT (4:00 PM BST)
• - Format: Live Webinar
• - Cost: Free

You can secure your spot in this vital educational session by registering here.

About Xtalks

Xtalks, powered by Honeycomb Worldwide Inc., serves as a leading source for digital content and educational webinars tailored to the global life sciences sector. The platform aims to keep industry professionals updated on the latest developments, regulations, and job opportunities. Through insightful discussions led by top-tier thought leaders and service providers, Xtalks supports professionals in maintaining a competitive edge within their fields.

In conclusion, this upcoming webinar marks an invaluable opportunity for anyone invested in advancing cell therapies from IND to BLA successfully. Don’t miss the chance to gain insights from seasoned experts and enhance your understanding of crucial CMC roles in this transformative phase.