Sabrina Restrepo | Director, Global Vaccines Technical Operations
Merck
Sabrina's responsibilities at Merck have included technical operations support in several areas such as deployment of single-use systems in vaccine manufacturing, process improvements for vaccines manufacturing, subject matter expertise in extractables and leachables, technical collaborations with single-use systems’ suppliers, regulatory remediation plans, cell culture media and drug substance manufacturing. Recently, she was a recipient of the 2018 Frost & Sullivan Manufacturing Leadership Award in the Engineering and Production Technology Leadership category for the Design, Evaluation and Implementation of Single-Use Components for Ebola Zaire Vaccines Drug Substance Manufacturing. Currently, she is the co-lead of the PDA Vaccines Interest Group.
Prior to joining Merck, she worked at Irvine Scientific, Allergan and the Instituto Colombiano del Petróleo where she contributed to the development and manufacturing of cell culture media products, process characterization and improvement of Botox® and development of biological wastewater technologies, respectively.
Sabrina has published four technical publications, received four recognitions within Merck, co-authored three BioPhorum Industry documents, and presented at numerous conferences.
She holds a BS and MSc degrees in Chemical Engineering from Universidad Nacional de Colombia and PhD degree in Engineering from the University of Akron, Ohio.
Appearances:
Pre-congress Workshops, April 6 @ 10:00
WORKSHOP G (FULL DAY): ANALYTICAL METHODS TO SUPPORT VACCINE QUALITY
Analytical methods that ensure identity, purity, and potency of vaccines have continued to improve but are primarily used for characterization rather than release testing. USP Biologics will gather stakeholders to learn about novel methods and to discuss opportunities to advance these methods in both pharmaceutical QClabs as well as global control laboratories. The workshop will include talks as well as an expert panel to debate these topics and address questions from the audience.Workshop leader opening remarks: Dr Maura C. Kibbey, Senior Scientific Fellow, Education & Training, Global Biologics, USPPresenations topics include:- Use of NMR assays for characterization of polysaccharide-based vaccines
- Opportunities and challenges of in vitro potency development for FSME Immun release and stability testing
- A regulatory perspective on NGS for adventitious virus detection in biologics
- Strategies and Examples for vaccine development and lifecycle management
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