Ensuring compliance with animal-free raw materials in CGT

The production of cell and gene therapies faces stringent regulatory requirements that demand the use of high-quality, animal-free raw materials to ensure patient safety and product consistency. Many manufacturers struggle to find reliable, compliant materials that also perform well in critical applications. This webinar will address these challenges by exploring validated solutions that help meet regulatory expectations while maintaining performance using animal-free materials.

Recombinant insulin supports cell proliferation and enables the development of chemically-defined media formulations essential for cell therapy manufacturing. Additionally, insulin plays a vital role in viral vector production for gene therapy, resulting in significant improvements in AAV titer and enhanced viral encapsidation in HEK 293 cells.

Additionally, recombinantly produced trypsin eliminates the contamination risks inherent in animal-derived trypsin and ensures consistent enzymatic activity while maintaining excellent cell viability and essential surface markers during passaging procedures, making it an ideal solution for cell therapy manufacturing workflows.

A recent study evaluated the performance of both recombinant insulin and trypsin in mesenchymal stem cell cultures, demonstrating that insulin effectively stimulates cell proliferation while trypsin nicely maintains cell viability and phenotype during dissociation, together meeting the rigorous standards required for therapeutic manufacturing applications.

The featured speaker will demonstrate how these validated animal-free solutions can transform manufacturing processes, offering practical insights into optimizing both cell and gene therapy production while ensuring regulatory compliance and cost-effectiveness.

Register for this webinar to explore how animal-free raw materials support regulatory compliance and optimize CGT manufacturing performance.

Speakers

Sara Bursomanno, PhD, Senior Global Product Manager, Novo Nordisk Pharmatech A/S

Sara Bursomanno is a seasoned expert in Cancer Biology with over a decade of experience in academic research. Having transitioned to the biopharmaceutical industry over six years ago, Sara has excelled as a Product Manager, focusing on the upstream manufacturing of biological drugs.

Her specialized knowledge in cell culture and protein production allows her to effectively bridge the gap between scientific research and practical industry applications.

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Chantale Julien, Global Product Manager, Novo Nordisk Pharmatech A/S

With over 20 years of experience in the pharmaceutical industry, Chantale is currently a Global Product Manager at Novo Nordisk Pharmatech A/S, where she manages several product portfolios.

Her role encompasses providing technical and scientific support, strategic market positioning and adherence to GXP requirements.
Throughout her career, she has held positions at the Canadian Food Inspection Agency, Novonesis (previously Chr. Hansen A/S) and Cook Medical, in various management roles that emphasize compliance, life-cycle product management and API distribution.

Mrs. Julien earned her Master’s degree in Animal Sciences from Université Laval in Québec, Canada.

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