Key Assets

Global Private Treaty For Sublease of R&D Facility. The site offers state of the art facilities that fulfilled the strict requirements of EU GMP for Manufacture of Sterile Pharmaceutical Products Including Advanced Therapy Medicinal (ATMP) products.

  • Facility occupies 1,200 square meters with classified areas complying with EU GMP Annex 1 – grades  A, B, C and D (ISO 5, 7 and 8)
  • New clean room approved in 2012 by Danish Health & Medicines Agency (DHMA)
  • Facility held the following licences issued by DHMA:
    • Tissue Establishment Licence
    • GMP Manufacturing Licence for chondrocytes

 

  • Internal engineering services include:
    • Design of cell culture cleanrooms  in compliance with ISO and Annex 1
    • Expertise with handling of materials and methods
    • Commissioning / start-up
    • Certification and validation to current standards
  • The following programs are established:
    • Environmental Microbiological Testing Program

–Viable and Non-viable particles

–Personnel

–Facility

    • Equipment Testing Program
    • Clean Room Cleaning Program
    • Sterility Assurance Program
    • HVAC and HEPA Systems
    • Building Management System (BMS)
    • Facility Management System (FMS)

LEASE TERMS:

  • Can be Terminated with 6 month notice on either October 1st, 2015  or October 1st, 2019
  • Monthly Lease payments are kr76,746.10 Including VAT
  • Common expenses on account (e.g. real estate tax, water, sewer), per month: DKK 11.000,00 incl. VAT
  • Heating costs on account, per month: DKK 11.750,00 incl. VAT
  • Electricity: Cost Based on 1 year’s consumption and full capacity in both offices and clean rooms (01-JUL-2013 to 30-JUN-2014) average cost per month: DKK 80.287,54 incl. VAT
  • Deposit equals to 6 month’s rent (at any time)
  • The rent is regulated with an increase of 3% every October

 

Click Below For Facility Information

Copenhagen Facility Specs November 2014