GMP SERVICES FACT SHEET

GMP PRODUCTION FACILITIES

Our facilities are easy accessible from Munich airport and easy to reach by public transport or by car.

MUNICH / OTTOBRUNN
– Main facility –
Haidgraben 5
D-85521 Ottobrunn, Germany

MUNICH / GROSSHADERN
Max-Lebsche-Platz 30
D-81377 Munich, Germany

The facility is close to the University Clinic Großhadern, one of Germany’s most famous clinical centers.

With our location at the heart of Europe, apceth Biopharma can guarantee fast supply of your IMPs across the continent.

CLEANROOMS

  • 9 cleanrooms with a total floor space of 600 m2
  • Certified: GMP / BSL2; ISO 5, ISO 7, ISO 8
  • Unique combination of certified GMP and BSL2 status: authorized to work with genetically modified cells and vector systems
  • Uni-directional material flow
  • Facility for clients directly to observe the production process

PROJECT MANAGEMENT

  • Well-established project management
    system (Handbook)
  • Dedicated project manager per client project
  • Thorough, but flexible and customizable
    project management solutions
  • Efficient, timely, clear and uncomplicated
    project handling
  • Risk management
  • Continuous and transparent communication
    between apceth Biopharma and the client

REGULATORY COMPLIANCE

  • Fully compliant with all current EU regulations, including EU ATMP regulation (EC)No.1394/2007
  • Certified GMP status, BSL2 status
  • In house Qualified Persons (QPs)
  • Well-established quality management

OPERATIONS

  • Well-established Enterprise Resource
    Planning (ERP) system
  • Handling almost 2,000 materials with ease
  • Well-established business continuity concept
    (including independent power supply)

SHIFT MODEL

  • Standard shifts: five days
  • Flexibility to extend to two shifts over seven days
  • 24/7 on-call duty

MANUFACTURING LICENSES

  • For different types of complex cell and gene therapy products (EU regulatory definition: Advanced Therapy Medicinal Products)
  • Native and genetically engineered cells

CLIENTS

  • Large international pharma
  • Emerging biotech

CELL TYPES

  • Mesenchymal stem cells (MSC)
  • Hematopoietic stem cells (HSC)
  • Lymphocytes and monocytes
  • Dendritic cells
  • Cord blood-derived stem cells
  • CAR-T and induced pluripotent stem cell (iPSCs) technologies possible
  • Autologous and allogeneic
  • Native and genetically modified (retroval and lentiviral)

CELL SOURCES

  • Bone marrow
  • Peripheral blood, apheresis
  • Umbilical cord, umbilical cord blood
  • Other cell sources