Accelerating Early Phase Biologics from the Clinic to Commercialization
Webinar Overview
In this webinar, experts Abzena and Sartorius discuss the important role that key technologies and processes play in expediting an early-phase biologics path to the clinic and beyond will be discussed.
The mammalian cell-based biomanufacturing industry continues to lead the market for biologics. These include monoclonal antibodies (mAbs), fusion proteins, antibody fragments, bispecific and bifunctional antibodies and antibody-drug conjugates (ADCs). After decades of development, these drugs are proving to be highly efficacious; however, to meet increasing demands, the industry needs robust and flexible production processes and technologies that are also cost-effective while ensuring product quality and consistency. Many of the new generation of mAb-related products require additional process development compared to traditional mAbs. If drug developers seek to maintain their path to clinic with the speed at which these new modalities are coming through from discovery, they will require strategies that are efficient, scalable, yet straight-forward and transferable. In recent years, fully integrated end-to-end single-use technologies combined with advances in cell line development (CLD) and new purification platforms have transformed manufacturing platforms and processes for early-phase biologics.
Process changes and improvements can be achieved rapidly for new and existing processes without detrimentally impacting product quality. From defining and testing a scalable process for Phase I to optimizing and characterizing the process for late phase and commercial launch, the speakers will draw on their experience in applying QbD techniques from process design to continual improvements across multiple therapeutic modalities.
Using case studies, the expert speakers will demonstrate how Abzena utilizes Sartorius’ technologies while applying a quality by-design (QbD) approach based on proven science and engineering techniques to establish a strategy that allows for rapid process development and implementation in a contract development and manufacturing organization (CDMO) setting.
Access this on-demand webinar to gain insights into:
- How an established routine, expertise and single-use technologies can provide a solid foundation for success in antibody development
- How a modular downstream process can be designed for plug-n-play flexibility while maintaining agility to meet development timelines
- How scalable process trains can seamlessly take a biologic from benchtop to commercial scale manufacturing
- How quality documentation can aid in quality improvements
- How single-use technologies can enhance quick turnover, ease of implementation and time to market
Speakers:
- Dennis J. Yoon, PhD, Senior Director, Manufacturing Science and Technology, Abzena
- Priyanka Gupta, Head of Product Solutions and Marketing, Separations Technology, Sartorius
Access the On-demand Recording:
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