Leveraging our vast regulatory experience and proven technology platforms, we play the role of an experienced co-pilot to bring life-changing gene therapies safely to patients.
As pioneers and industry leaders, we are setting the standard for vector safety and integration site analysis. Our CEO, Dr. Manfred Schmidt, is a leading expert in the field and was involved in the safety assessment of many cell and gene therapy drug products, including Glybera®, the first gene therapy drug product approved in the western countries, for treating Lipoprotein Lipase Deficient (LPLD)
For more than 20 years, we have worked alongside clients around the world to develop novel cell and gene therapies that meet regulatory safety requirements. Our clients rely on our deep scientific, technical and regulatory expertise to de-risk their cell and gene therapy development pathway.
As a credible partner with proven expertise in the field, we function as an extension to your internal teams to bring breakthrough therapies in development to market authorization.
Our vision: Become the world’s leading facility for cell and gene therapy biosafety testing. We will continue to innovate to deliver on the promise of safer gene therapies for patients in need.
Our mission: Provide best-in-class molecular diagnostics and analysis services to ensure the safety of novel cell and gene therapies. Towards Safer Therapies.
Our core values: Focus on delivering customer-oriented services with transparency, respect and trust.
This deep commitment to our clients prompts us to go the extra mile to develop and validate assays and technologies to probe challenging biosafety concerns.
We understand what it takes to bring life-saving therapies to the clinic.
GeneWerk’s journey began long before the company was officially founded in 2014 by Prof. Dr. Christof von Kalle, Dr. Manfred Schmidt and Dr. Annette Deichmann, together with German Cancer Research Center (DKFZ).
Today, we are a team of >30 employees providing expertise and services to clients around the world from Heidelberg, Germany.View our history