About Us
Stolley Engineering is a globally operating company with expertise in GMP. We specialize in validation and qualification of sterile manufactured biopharmaceuticals, biosimilars and gene and cell therapy. To date, we have helped clients sail their products through regulatory scrutiny and reach manufacturing and marketing authorization.
We have 20+ years of proven and sound knowledge in cell and molecular biology and gene technology. Project lead or team work will be provided by our well-versed and long-term experienced engineers. We perform on-site services and give presentations or training on the relevant subjects. Our services are tailored to customer needs and exigencies.
Our aim is to contribute to the implementation of GMP quality standards as they pertain to the biopharmaceutical industry and gene and cell therapy.
Our Mission
Stolley Engineering leverages their expertise to solve GMP needs and exigencies between customers and regulatory authorities.
Our Vision
With enthusiasm and passion for medical innovations and technologies, we guide our clients through validation and qualification operations, on their road to cGMP compliant processes.
What we stand for
Expertise and experience, commitment and dedication, mind and reason – this is what makes us uniquely different.
“Be good if you can, and if you can’t be good, do the best you can.”
by Daniel L. Jackson, San Diego, CA
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 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 Psychiatry 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 to Micromet. At mircomet I was responsible for the 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 validation of bioassays for GMP release and marketing authorization and 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 hands-on experience in biomedical research and bioprocessing of biological products and Immunotherapeutics, 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