Webinar: Accelerating Early Phase Biologics from the Clinic to Commercialization

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In this webinar, 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.

In this webinar, attendees will 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

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Speakers:

Dennis J. Yoon, PhD, Senior Director, Manufacturing Science and Technology, Abzena
Dennis J. Yoon manages the Abzena team supporting technology transfer, scale-up and technical support of biologics manufacturing from process development to cGMP Operations. He has over 12 years of broad industry experience in medical device and biopharmaceuticals with progressive leadership positions in operations and quality. He received his PhD in Biomedical Engineering from the University of California, Los Angeles, where he engineered proteins for targeted drug delivery in cancer treatment.

Priyanka Gupta, Head of Product Solutions and Marketing, Separations Technology, Sartorius
Priyanka Gupta is a senior expert for bioprocess solutions where she works on centralizing BPS market positioning and messaging for process intensification by working with all stakeholders. Priyanka began her career as a Process Development Engineer and worked at Immunex and then at Amgen for five years.  She joined Sartorius in 2007 as a Process Development Scientist DSP. Later, she became a Senior Manager, Global Process Modelling; Head of Go to Market Strategy Protein Based Therapeutics where she led the Process Intensification USP campaign and most recently was the Manager of External Collaborations, Separations Technology.  Priyanka participates in industry advocacy activities and notably heads industry groups within NIMBL. Priyanka has an MSc in Chemical Engineering and is based in San Francisco, US.