• Capitalising on COVID successes and keeping the momentum going;
• Can excess manufacturing capacity be repurposed?
• Scientific and data driven predictions for the future of bioprocessing.

• During product development and the life cycle of commercial products, process changes are inevitable. Products manufactured using pre- and post- process changes are required to demonstrate comparability per ICH Q5E. A comparability study is a critical tool to ensure the “similarity” of product quality including efficacy, pharmacokinetics, safety and immunogenicity.
• In this presentation, a phase appropriate risk assessment of process change will be introduced, followed by comparability strategy based on the risk assessment. Analytical comparability study tools will be discussed including the analytical comparability plan, comparability criteria, execution, data analysis and presentation. Furthermore, non-clinical and clinical comparability will be briefly discussed if there is any analytical difference which may impact product quality. Two comparability case studies will be presented. The first study is to support a new bioprocess to improve product quality and to facilitate larger scale manufacturing. The second one is to support the use of an early process stability study for establishing commercial shelf-life by leveraging the comparability study for an accelerated program. The agency feedback from multiple markets for the case studies will also be discussed.

Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.

Contact us today to learn more: Partners@informaconnectls.com

• How CDMOs have evolved in the last 5 years and what to expect in the coming years;
• Geopolitical uncertainty and its impact on outsourced manufacturing;
• Collaboration to understand the changing needs of pharma and biotech.

Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.

Contact us today to learn more: Partners@informaconnectls.com

• Identifying and mitigating project, technical, and operational risks
• Ensure consistent product quality and robust processing across manufacturing sites through global integration
• Digitalization of tech transfer workflows and knowledge management

In today’s fast-paced tech landscape, expediting the licensing of innovative technologies is crucial for success. However, many organizations struggle to effectively communicate their offerings to potential licensees. This presentation explores the often-overlooked question: Are we using the right technology to get the word out? We will analyze various outreach methods—from traditional networking to modern digital platforms—and their effectiveness in reaching target audiences. By examining case studies and best practices, we will identify key strategies for leveraging the latest communication tools to enhance visibility and engagement. Attendees will leave with actionable insights on optimizing their technology outreach efforts, ultimately accelerating the licensing process and driving innovation forward. Join us to discover how to align your messaging with the most effective channels to ensure your technology gets the attention it deserves.