Alicja Fiedorowicz, MSc.

Alicja joined DHC in 2021 and since then has had the opportunity to work with a variety of clients across all stages of product development, from early clinical to commercial (including MAA/BLA regulatory authorship and support). She focuses primarily on analytical and quality control strategies in addition to tech transfer and CMC regulatory support.

Alicja’s pre-DHC career started in Proxima Concepts, where she was responsible for development and optimization of cell-based assays and gained substantial hands-on experience in maintenance of mammalian cell cultures.

After that, Alicja moved to Pfizer Genetic Medicine Institute where she was the first member of the analytical team. She was responsible for setting up the analytical laboratory as well as tech transfer and optimization of analytical assays for the testing of AAV vectors.

While at GSK, Alicja was responsible for the cell culture and molecular biology laboratory in the QC C&GT unit, from the implementation phase and validation of equipment and software through design of quality control systems and procedures. She was also responsible for technology transfer of analytical assays for testing of CAR-T and TCR T products. Additionally, she supported GMP inspection activities and authored sections of the regulatory filings.

Just before joining Dark Horse Consulting, Alicja was the analytical operations workstream lead for the cell therapy product Libmeldy™ at Orchard Therapeutics. The key responsibilities for this role included overseeing all analytical development/validation and quality control activities, the lifecycle of analytical methods, analytical comparability, release testing, stability studies, supporting quality activities, and regulatory submissions (MAA/BLA filings). She was one of the authors of the MAA filing for Libmeldy™, a product treating a devastating condition called Metachromatic Leukodystrophy (MLD), which was granted approval in 2020 by EMA.

• Supported clients during gap analysis for IND- and FDA-readiness
• Developed phase-appropriate release testing and characterisation strategy for multiple clients.
• Led optimization activities for several potency/identity assays for commercial cell therapy product
• Analytical lead for the commercialization of Libmeldy™; responsible for the release testing strategy, gap analysis, briefing book preparation, and MAA suport

• Mack A, Fiedorowicz, A. (2024) FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies. Cell and Gene. May 24: Guest Column‍
• Morse B, Fiedorowicz A. (2024) Control of Analytical Considerations for Gene-Modified Hematopoietic Stem and Progenitor Cell Therapies in BioProcess International Part 1 — In-Process and Drug Product. BioProcess International. May 10: Guest ; Part 2 — Starting Materials and Drug Substances. June 19: Guest Column

British Pharmacopoeia Commission Advanced Therapy Medicinal Products (ATMP) Working Party

Orchard Therapeutics
Manager, Analytical Operations

GSK
Senior QC Scientist

Pfizer
Analytical Scientist

Proxima Concepts
Research Assistant

Wroclaw University of Technology
BSc, MSc in Biotechnology

University of Business, Wroclaw
Innovative Management, postgraduate certification