UpTempoSM Antibody: A Streamlined Platform Process to Accelerate Biotherapeutics from Gene to Clinic

Catalent’s UpTempoSM Antibody combines the industry-leading GPEx® cell line development technology with streamlined, phase-appropriate drug substance development to deliver products from early-stage development through GMP manufacturing. The UpTempo Antibody platform process enables an 11-month timeline from gene to clinic.

Register Free: https://www.biopharminternational.com/bp_w/accelerate-biotherapeutics

Event Overview:

Speed to clinic is a top priority for the majority of biopharmaceutical companies. Harmonizing technological innovation with platform biomanufacturing development and knowledge can address the time and cost barriers for protein biologics while producing stable, high-expressing antibody-based therapeutics. Catalent’s UpTempoSM Antibody platform process combines industry-leading GPEx® cell line development technology with streamlined, phase-appropriate drug substance development to deliver products from early-stage development through GMP manufacturing. In addition, UpTempoSM Antibody provides a flexible platform process for multi-chain expression and scalable manufacturing with consistent performance and product quality – all key aspects to deliver biotherapeutics on an expedited timeline for clinical trials.

Key Learning Objectives:

• How UpTempoSM Antibody addresses key challenges bringing antibody therapeutic programs to clinical trials
• What innovative technology and phase-appropriate, scalable bioprocessing developments are applied from gene to GMP batch release
• How to deliver high-expressing, consistent antibody therapeutics on expeditious timelines for clinical studies

Who Should Attend:

• Chief scientific officers
• Process development scientists
• CMC engineers
• Bioprocessing engineers
• Upstream development scientists
• CEOs, VPs and Consultants of biologic development
• VPs of bioprocessing
• VPs of process development
• VPs of biomanufacturing
• Directors of biologic development, bioprocessing, process development and biomanufacturing
• VPs and Directors of bioproduction
• Directors of biologics

Speakers:

Laura Daley, PhD
Senior Director, Molecular & Cellular Biology
Catalent Biologics

Dr Laura Daley is a Senior Director at Catalent Pharma Solutions, for which she supports Cell Line Development, R&D, and Cell and Molecular Biology activities. Laura received her PhD in Pharmacology and Physiology from Saint Louis University School of Medicine. She has over 16 years of industry experience in stem cell biology and gene editing, and continues to leverage her expertise in developing innovative platforms for protein manufacturing at Catalent.

Tyler Gadoury
Senior Director, Process Development
Catalent Biologics

Tyler Gadoury currently serves as Senior Director of Process and Analytical Development at Catalent Pharma Solutions. He has over a decade of clinical and commercial biologics drug substance experience across numerous modalities, working with companies all over the world. Tyler holds a BS in Chemical Engineering, an MBA, and is a certified Lean Six Sigma Black Belt.

Register Free: https://www.biopharminternational.com/bp_w/accelerate-biotherapeutics