Julia Hecker
Scientific Operations
BioAgilytix
Presentation
Potency Assay Transfer Across Sites: A Kinetic Enzymatic Gene Therapy Case Study
Friday, 25 September
11:15 – 11:45
Session: Workshop 3: Bioassay Basics – Part 2
BioAgilytix is your trusted, science-first partner for outsourced Chemistry, Manufacturing and Controls (CMC) Quality Control (QC) testing services. Supporting programs across all modalities, from early analytical development through validation, QC testing, stability studies, and commercial release, we have adopted a risk-based, well-documented, and scientifically justified approach to maintain analytical consistency that aligns with all regulatory expectations.
By integrating analytical development and QC testing within a collaborative scientific framework, sponsors gain direct access to the scientists supporting their program, providing broader expertise, faster problem-solving, and greater flexibility to quickly pivot maintaining consistent quality monitoring and control throughout product development.
Backed by fully GMP-compliant laboratories in Hamburg, Germany, and Durham, North Carolina, we deliver the precision and reliability your therapeutics demand across the EU and beyond.
Scientific Operations
BioAgilytix
Presentation
Potency Assay Transfer Across Sites: A Kinetic Enzymatic Gene Therapy Case Study
Friday, 25 September
11:15 – 11:45
Session: Workshop 3: Bioassay Basics – Part 2
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The BEBPA European Bioassay Conference brings together scientists and industry experts to discuss emerging best practices and the latest advances in analytical biopharmaceutical development. Through scientific presentations, workshops, and collaborative discussions, the conference fosters innovation and knowledge sharing to help accelerate the development of safe, high-quality biopharmaceutical products.
At BioAgilytix, every development program begins with a tailored analytical strategy designed to generate reliable, regulatory-ready data. Our scientific teams partner closely with sponsors to navigate complex analytical challenges while supporting critical development decisions.
With laboratories across North America, Europe, and Australia, BioAgilytix combines global operational scale with localized scientific support. From early discovery through commercialization, our integrated laboratory network helps sponsors move programs forward with confidence.
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