Three Phases Towards Success
A successful technology transfer must always be underpinned by solid scoping, planning and execution. From establishing a project’s foundations to defining resources and developing schedules, through to data collection and reporting, it is key to outline all elements clearly from the outset.
This is the case for sterile injectables, which have special considerations to factor in on the path to market. From extractables and leachable analysis to lyophilization cycle robustness and process parameters, the transfer and equipment changes can have a significant effect on product formulations.
Register for this webinar to hear Lei Zheng and Jeny Quint from Pfizer CentreOne discuss the three phases of a technology transfer on a sterile injectable project, covering how to bridge information gaps and facilitate the path to successful regulatory filing at this fundamental stage of drug development.
Speakers
Lei Zheng, Global Technology & Engineering, Pfizer CentreOne
Lei has 25 years of professional experience focused on sterile injectable products and medicinal chemistry. Her career started in academia as an assistant professor of medicinal chemistry and transitioned into pharmaceutical industry shortly thereafter with Abbott Laboratories. Lei held positions of incremental responsibility including R&D scientist, QC manager, MSAT lead, and transfer project lead. She joined Pfizer through a company acquisition and focused her work on managing tech transfer projects and sterile injectable technical support.
Currently, Lei is a Director in Global Technology and Engineering, responsible for tech transfer projects from multiple EU manufacturing sites into locations in China. Lei is a certified project manager.
Message Presenter
Jennifer Quint, Senior Manager, Pfizer CentreOne Technical Services
Jennifer Quint is the Senior Manager for the Pfizer CentreOne Technical Services team. Jennifer leads a team of chemists and microbiologists who execute compendial and method development in support of internal and external Phase II/Phase III tech transfer projects. Her focus is on GMP compliance while driving alignment of cross-functional development teams.
Previously, Jennifer was a Development Services Manager for Hospira where she was responsible for project milestones, invoicing, customer relationships and development contracts. In that role, she led internal cross functional teams and worked with customers to drive their program from clinical to commercialization. Previously, Jennifer was a Group Leader for R&D Microbiology and worked as a microbiologist in the laboratory supporting method development for both internal and external projects.
Jennifer joined Abbott in 2003 and has been a part of the Pfizer CentreOne organization for over 17 years with experience in leadership, science and customer manufacturing business activities.
Message PresenterWho Should Attend?
- Corporate Development & Technology
- Product Development and Operations
- Executive Director
- Chief Executive/Scientific Officer
- Business Development
- Regulatory Affairs and Product Development
- Technical Operations
- Pharmaceutical Development
- Product Development/Manufacturing Controls
- Manufacturing Services
- Formulation Development
What You Will Learn
In this webinar, participants will learn about:
- An overview of the three phases of a tech transfer and what is important at each phase
- The considerations for technology transfer in a sterile injectable project
Xtalks Partner
Pfizer CentreOne®
Pfizer CentreOne® is a global CDMO embedded within Pfizer and a leading supplier of specialty APIs. Our global manufacturing network includes more than 35 sites across six continents. Backed by Pfizer resources, we deliver technical expertise, global regulatory support, and long-term supply. For more than 40 years, we’ve been guiding complex compounds securely and efficiently from development through commercial manufacture.
Working together with our customers, we combine our technical and commercial knowledge with open dialogue to solve challenges. Intelligent collaboration with Pfizer CentreOne. For more information, visit www.pfizercentreone.com.
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