apceth Biopharma’s Ottobrunn facility is the company’s main manufacturing location. It satisfies the highest technological and methodological standards currently available in the fields of molecular and cell biology, immunology and cell culture. The broad spectrum of our methods encompasses all aspects of GMP manufacturing and quality control for all types of ATMPs.
MUNICH – GROSSHADERN
As in our main production facility in Ottobrunn, apceth Biopharma’s Großhadern facility satisfies the highest technological and methodological standards available in the fields of molecular and cell biology, immunology and cell culture. The Großhadern facility offers a broad spectrum of methods, encompassing all aspects of GMP manufacturing and quality control for different types of ATMPs.
This facility is located very close to the University Clinic Großhadern (Klinikum Großhadern, LMU), one of the most respectable clinical centers in Germany.
Cleanroom classification: ISO 5, ISO 7, ISO 8 / BSL2 / GMP
cleanrooms of class B and C with class A laminar flows Accompanying units:
• Quality control laboratories
• Cool and cold storage
• General GMP storage areas
• 24/7 supervised cryofacility
Type of Projects
Cryopreservation and cell banking
Type of Products
Fresh and frozen products
Genetically engineered and native cells
Different types of cells: MSC, HSC, immune cells
Gene therapeutics, therapeutic vectors
Several types of complex cell and gene therapy products (EU definition of Advanced Therapy Medicinal Products, ATMPs)
Native and genetically engineered cells
Clinical and commercial applications
Compliant with all EU regulations and general FDA guidelines
continuously ready to satisfy the needs of the running clinical trials. The manufacturing of each product can be optimized to follow the requirements of the ongoing clinical trial and the speed of the trial recruitment.
one project manager is assigned to each client project, guaranteeing uncomplicated, timely and efficient project handling.
full regulatory compliance and highest quality processes and products.
for product release are continuously available on-site.
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