Development of innovative biologics therapy is challenging due to molecular complexity, time intensive processes, and high failure rate in process development and in the clinic, making the process long and expensive.
Deeper knowledge of the physiochemical properties biologics can aid in decision-making early in development and help inform improvements during the transition from discovery to the biologics license application (BLA). This webinar will detail improvements we have implemented during our development process and focus on the benefits of an appropriate analytical toolkit to fit the needs of the biologic and process being developed.
Our use of liquid chromatography coupled to mass spectrometry (LC-MS) for surveying physical and chemical properties of biopharmaceuticals will be highlighted in this webinar. We will demonstrate the benefit of monitoring critical attributes that have the potential to impact stability, function or appearance in the final product. Our approach gains the most benefit by using this analytical toolkit during the early process development stages. We will highlight a few key examples where monitoring proves to be most impactful in the process, for example in cell line development or downstream process development.
Powerful analytics can decrease timelines and enhance process robustness, but also provide a deeper understanding of the impact of process steps on product quality. By the end of the webinar, we will have demonstrated that selecting key product attributes and monitoring those attributes through process development can have a major impact on the product quality.
Register for this webinar to learn about how using those key attributes to monitor the processes under development can decrease timelines, improve product quality, reduce cost and enable the implementation of key knowledge gained from a well-informed analytical toolkit including MS technology.
Christa Feasley, PhD, Senior Analytical Development Scientist, Cytovance Biologics
Christa Feasley leads the Mass Spectrometry services at Cytovance and has more than a decade of protein characterization and mass spectrometry experience developing novel analytical workflows for a wide range of therapeutics. This extensive array of experience is demonstrated in the authorship of more than 20 scientific peer-reviewed publications, application notes, white papers, scientific presentations and workshops, and application or hardware specific training materials.
Who Should Attend?
This webinar will appeal to:
- Pharmaceutical/biotech companies developing innovative biologics or biosimilars
- Pharmaceutical/biotech companies aiming for IND submissions
- Program leaders of drug candidate pipelines
- Senior Managers and executives from pharmaceutical and biotech companies
- Research scientist
- Head of R&D
- Laboratory technician/supply chain manager
What You Will Learn
In this webinar, participants will learn about:
- How development of a tailored analytical toolkit for biologics can help to speed timelines and ensure product quality
- How to monitor critical attributes to improve process development outcomes
- Strategies to save time and money to help early phase trial goals and milestones
Cytovance® Biologics is a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that excels in the rapid and cost-effective development and manufacture of large molecule APIs from both mammalian cell culture and microbial fermentation, such as monoclonal antibodies, fragment antibodies, bispecifics, enzymes, fusion proteins, vaccines, and other biological products including plasmid DNA and cell-based therapeutics. In addition to our clinical and commercial cGMP API manufacturing services, Cytovance offers well integrated development services supporting the entire product lifecycle, including cell line development, cell banking, microbial strain development, process and analytical development, and process characterization. A centralized, responsive program management team coordinates all critical CMC activities for each client program around raw materials management, QC testing, ICH stability studies, and regulatory support. Our 140,000 sq. ft. state-of-the-art facilities in Oklahoma City are designed to meet U.S., EU, and other global regulatory standards.