Reduce Biologics Development Risk Across the Product Life Cycle
About this webinar
Successful biologics programs depend on making the right decisions at the right stage of development. Early choices in cell culture strategy, media and feed optimization, downstream recovery, analytical control strategy and scale-up approach can significantly affect yield, quality profile and manufacturing consistency later in the life cycle. In a competitive environment, development teams must balance speed, risk and platform fit while preserving flexibility for future process evolution.
This webinar will explore practical decision points across the biologics product life cycle, with emphasis on how process development, manufacturing science and quality systems can work as one integrated system. The featured speaker will examine how data packages, design space knowledge and risk-based planning support smoother technology transfer, reduce development risk and costly rework, improve process performance and enable faster GMP execution.
By connecting development decisions with downstream manufacturing requirements, the session will demonstrate how an integrated development-to-manufacturing approach can support reliable, reproducible and commercially relevant supply.
Register for this webinar to learn how product life cycle decisions can improve biologics process performance, technology transfer and GMP execution.
Who should attend
- Cell Culture, Upstream Process Development and Downstream Process Development professionals
- Analytical Development and Analytical Sciences professionals
- CMC leaders and Technical Program Managers
- Regulatory Affairs and Regulatory CMC professionals
- Quality, Compliance and Quality Systems leaders
- Technical Operations, Manufacturing Science, MSAT and Technology Transfer teams
- R&D Heads and Development Directors
- Biologics, Peptide and Advanced Therapeutic Program leaders
- Professionals responsible for process scale-up, manufacturing readiness and GMP execution
- Decision-makers responsible for outsourcing strategy, CDMO partnerships, development acceleration and supply continuity
What you will learn
- Early development decisions that affect process robustness, product quality, manufacturing cost, scalability and supply reliability
- How integrated process, analytical, manufacturing and quality strategies can reduce development risk and avoid costly rework during technology transfer and GMP execution
- How data-driven process understanding and design space knowledge enable more informed risk-based decisions and improve process performance throughout the product life cycle
- How technology transfer should be designed into the development strategy from the beginning rather than treated as a separate downstream activity
- How platform knowledge, manufacturing science and scalable process strategies can accelerate development while preserving flexibility for future process evolution
- How an integrated development-to-manufacturing model can help sponsors translate development intent into reliable, reproducible and commercially relevant supply
Featured Speakers
Rajat Ghosh
Rajat Ghosh is a biopharmaceutical manufacturing and CMC leader with extensive experience in drug substance manufacturing, process development, MSAT, technology transfer, process scale-up and manufacturing strategy for complex biologics across diverse modalities, including biosimilars, novel biologics, monoclonal antibodies and bispecific antibodies. As AVP and Head of Drug Substance Manufacturing at OneSource, he leads manufacturing operations and strategic initiatives focused on process robustness, manufacturing readiness, operational excellence and reliable GMP supply.
Prior to joining OneSource, Rajat held senior technical and leadership roles at leading biopharmaceutical organizations, including Lonza Biologics, Ferring Biologics Innovation Centre, Switzerland, Lambda Therapeutics Research, India, Biocon Biologics, India, Sun Pharmaceutical Industries, India, Reliance Life Sciences, India, Cadila Healthcare, India and Wockhardt Limited, India. His experience spans MSAT, downstream process development, microbial MSAT, process development, technology transfer and manufacturing science.
Over the course of his career, he has led cross-functional teams and supported the development, scale-up, transfer and manufacturing of advanced biologics modalities programs for global markets. His expertise lies at the intersection of process science, manufacturing strategy, CMC execution and operational leadership.
Partner for this event
OneSource
OneSource Specialty Pharma Limited is a pure-play specialty pharmaceutical CDMO. The company focuses on the development and manufacturing of complex pharmaceutical products including biologics, drug-device combinations, sterile injectables, and oral technologies (soft gelatine capsules). It has five state-of-the-art manufacturing facilities approved by global regulatory authorities and a dedicated team of over 1,600 professionals. OneSource with its development capabilities, industry leading manufacturing capacities, and strong compliance track record, has won trust of global pharmaceutical companies seeking efficient, end-to-end solutions. For more information, please visit www.onesourcecdmo.com