De‑Risking Biologics Development: Practical Strategies to Move Faster from Cell Line to Clinic
As monoclonal antibody pipelines expand and competition intensifies, biopharma teams face a familiar dilemma: how to move faster without compromising manufacturability, budget, or long-term scalability. Traditional development models often optimize for early speed, only to encounter challenges in titer, robustness, or tech transfer later, resulting in rework, delays, and adding CMC risk.
This webinar explores a more integrated approach to monoclonal antibody development, one that embeds manufacturability, scalability, and lifecycle readiness from the earliest stages. We will discuss how accelerated clone-to-IND strategies, combined with next-generation cell line development and process engineering, can significantly compress development timelines while improving productivity and process robustness.
Using real-world development scenarios, the session will highlight how Syngene’s mAb Accelerator program enables rapid progression from cell line development through early clinical manufacturing. Syngene will also look at how SynWeave™ redefines upstream performance by delivering stable clones with higher titers and optimal critical quality attributes, improving process consistency, and thereby leading to simpler purification. Together, these capabilities help de-risk development, reduce cost of goods, and reach your clinical milestones faster.
Key Takeaways
Designing mAb development programs that balance speed with long-term manufacturability
Overcoming common bottlenecks in early-stage cell line and process development
Leveraging integrated CDMO platforms to streamline scale-up and tech transfer
Building a future-ready CMC strategy from first clone to commercial readiness.
This webcast is ideal for CMC leaders, process development scientists, and program managers seeking to accelerate mAb development while maintaining control over quality, scalability, and total lifecycle cost.
Key Speakers
Sunit Maity, PhD
Sunit Maity is a seasoned biopharmaceutical scientist with extensive experience in biologics and biosimilar development across academia and industry. He received his doctoral degree in developmental and cardiovascular biology from Leuven, Belgium, and began his industry career at Mermaid Pharmaceuticals in Hamburg, Germany, where he worked on target identification using model systems. He also conducted research at the Max Planck Institute, Germany, contributing to projects in CNS development.
After returning to India in 2007, Sunit joined Avesthagen, where he was head of the biopharmaceutical group and led the development of biosimilars, including recombinant proteins and monoclonal antibodies using mammalian expression systems. He subsequently joined Zumutor Biologics at its inception, serving as director of product development, leading process development and scale-up activities for novel monoclonal antibody programs in the immuno-oncology space.
Currently, he heads biopharmaceutical development at Syngene, where he continues to drive the development and advancement of complex biologics.
Samantha Hullah, PhD
Samantha Hullah is an accomplished biologics leader with more than 15 years of experience in the CDMO industry, recognized for her deep technical expertise and ability to translate scientific innovation into robust, scalable manufacturing solutions. She has led downstream recombinant protein purification programs as a technical lead and served as head of site for viral gene therapy process development and manufacturing at FUJIFILM Biotechnologies, overseeing end‑to‑end operational and technical execution.
In her current role at Syngene, Samantha provides strategic technical and CMC guidance to prospective biologics clients and acts as a critical technical bridge between commercial and operations teams, ensuring seamless program alignment and delivery. Based in Cambridge, Massachusetts, and originally from the Northeast of England, she supports a global commercial organization with a focus on scientific rigor, operational excellence, and partnership success.
