Contact
Nick Dove
1-858-847-0659
ndove@hginc.com
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