MUNICH – GROßHADERN FACILITY


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.

FACILITY DESIGN

Number of cleanrooms: 2
Cleanroom classification: ISO 5, ISO 7, ISO 8 / BSL2 / GMP:
Class B and C with class A laminar flows
Accompanying units:
• Cool and cold storage
• General GMP storage areas
• 24/7 supervised cryofacility

 

FACILITY CAPACITY:

Type of Projects

  • Product development
  • Product manufacturing
  • Reconstitution
  • Fill-&-finish
  • 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
  • Microvesicles

Manufacturing Licences

  • Several types of complex cell and gene therapy products (EU definition of Advanced Therapy Medicinal Products, ATMPs)
  • Native and genetically engineered cells

Regulatory Compliance

  • Compliant with all EU regulations and general FDA guidelines
  • Certified GMP status, BSL2
  • In house qualified persons (QPs)
  • Well-established quality management/quality assurance

manuFACTURING TEAMS

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.

PROJECT MANAGEMENT

one project manager is assigned to each client project, guaranteeing uncomplicated, timely and efficient project handling.

QUALITY MANAGEMENT

full regulatory compliance and highest quality processes and products.

QUALIFIED PERSONS

for product release are continuously available on-site.