About Stolley Engineering
Stolley Engineering is a globally operating company with expertise in GMP. We specialize in validation and qualification of sterile manufactured biopharmaceuticals, and gene and cell-based therapies.
Stolley Engineering aims to contribute to the implementation of GMP quality standards relating to the biopharmaceutical industry and treatment centers for gene and cell-based therapy . To date, we have helped clients sail their products through regulatory scrutiny and reach manufacturing authorization.
With more than 20+ years of proven and sound expertise in GMP engineering we offer GMP compliance consulting, team leadership or teamwork for your validation and qualification operations.
Customers we serve:
- Biopharmaceutical Industry
- Biotech Companies
- CDMOs
- Treatment Centers for gene and cell-based therapies (ATMPs)
- Healthcare Sectors
Our Mission
Stolley Engineering leverages its expertise to meet regulatory GMP requirements between customers and regulatory authorities.
Our Vision
With enthusiasm and passion for medical innovations and technologies, we guide our clients through their validation and qualification operations, on their way to cGMP compliant processes.
What We Stand For
Expertise and experience, commitment and dedication, mind and reason – this is what makes us uniquely different.
About Me
I hold a bachelor’s degree in medical laboratory technology (MTLA) of the Dr. Gillmeister Schule in Heide; Schleswig-Holstein and I studied bioengineering at the University of Applied Sciences of Munich and I hold a Diploma Degree (Dipl. -Ing.) in Bioengineering from the University of Applied Sciences of Munich.
I worked and trained at several research facilities e.g. at the Gene Center in Martinsried with Prof. Patrick Baeuerle, the Max-Planck Institute for Neurobiology in Martinsried with Prof. Yves-Alain Barde, at the La Jolla Cancer Research Foundation with Helene Bauribault, PhD, and at the Salk Institute with Prof. Dennis D. M. O’Leary.
After my stay in the USA, I moved back to Martinsried and contributed my expertise at Micromet. At Mircomet I was responsible for the design, development and validation of bioassays, i. a. of T cell-engaging bispecific antibodies for cancer therapy. After my stay with Micromet I contributed my expertise to Trion Pharma in the Quality Control Unit.
Here, I was in charge of the analytical instrument and process equipment qualification, the bioassays validation for GMP release and the bioanalytical method validation. I performed my diploma thesis at Serono Int. in Rome, Italy. The subject was to validate a bioassay for a monoclonal antibody for cancer therapy and the transfer of test methods.
To sum up my background, I am equipped with more than 20 years of hands-on experience in biomedical research and bioprocessing of biotechnological products in a GMP-related environment. If you are convinced by our web presentation you are cordially invited to contact us for detailed information. Together we are driving GMP.
Sincerely, yours
Sabine Stolley
“Be good if you can, and if you can’t be good, do the best you can.”
by Daniel L. Jackson, San Diego, CA