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Emily Lowe

Senior Director at Appia Bio

Strategic scientific leader with over 15 years of experience in cancer immunology and host-pathogen interactions with broad cross-functional knowledge in discovering and developing engineered cellular therapy products and new modalities from pre-IND to BLA/commercial stages. Core competencies include extensive experience in engineered immunity and cancer immunology, design and implementation of chemistry and manufacturing controls, analytical method development/validation and life cycle management, project leadership and team building. Areas of Expertise • Analytical Method Life Cycle Management – Method development using quality by design (QbD), analytical target profile (ATP), and design of experiment (DOE) approaches; method qualification and validation per ICH guidelines; implementation of risk-based approaches (method FMEA) for phase-appropriate life cycle management; phase-appropriate analytical method control strategies; analytical method tech transfer to clinical and commercial QC; continuous method monitoring, systematic deep-dive analyses of method performance, and implementation of method improvements to reduce invalid rates in commercial QC; implementation of new technologies into clinical and commercial QC • Product Quality Systems – Establishment of early and late target product profile (TPP/QTPP); development of phase-appropriate analytical methods for understanding process parameters, and product and material attributes; risk-based approaches (PQRA) to assigning critical quality/material attributes (CQA/MQA) and critical process parameters (process FMEA); implementation of analytical control strategies • Chemistry, Manufacturing and Controls – Author and review pre-IND briefing booklet, IND, BLA and MAA sections (Module 3; e.g. drug substance, drug product, elucidation of structure, analytical methods and controls); response to questions (RTQ); CMC strategies for analytical methods and controls

Contact Information

Personal Email
g*****@att.net
Direct Phone
+1 31********
Location
United States

Company Information

Company
Founded Year
2020

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View Colleagues

Edmund Kim
Edmund Kim

Chief Operating Officer

Qi Wei
Qi Wei

SVP, Head of TechOps

David Morse
David Morse

VP Head of Quality at Appia Bio

Frequently Asked Questions Regarding Emily Lowe

What company does Emily Lowe work for?
Emily Lowe works for Appia Bio
What is Emily Lowe’s role in Appia Bio?

Emily Lowe's role in Appia Bio is Senior Director

Who are Emily Lowe’s colleagues?

Emily Lowe's colleagues are Edmund Kim, Qi Wei, David Morse.