1. Biopharmaceutical Production Biopharmaceutical development and GMP manufacturing Professionally sound Reliable Innovative Open Respectful

2. Biopharmaceutical development and GMP manufacturing Development, Manufacturing and Quality control of products requiring Clean room facilities and cGMP Biopharmaceuticals for early stage clinical trial Containment of infectious and high potency materials Sterile pharmaceuticals and medical devices Microbiological and Chemical Analysis Professionally sound Reliable Innovative Open Respectful

3. Our Services Development of Formulation, Process and Methods GMP manufacturing and quality control Scale-up and technology transfer GMP- and QP- release of products GLP toxicity studies Validation Consultancy within related topics Biopharmaceutical development and GMP manufacturing Professionally sound Reliable Innovative Open Respectful

4. Competence –1 PhD Biotechnology –15 Master degree –4 Pharmacists –1 Genetics –1 Biology –4 Microbiology/Food science –5 Chemical/Biochemical engineering –11 Bachelor degree –9 Chemists –2 Bioengineers –12 Technicians Biopharmaceutical development and GMP manufacturing Professionally sound Reliable Innovative Open Respectful 39 comprehensively educated and trained employees Several hundred years of experience within GMP processing of biological substances

5. Manufacturing Services Sterile and aseptic products Cultivation of Bacteria, Cell and Virus Concentration & Purification Formulation & Blending Biopharmaceutical development and GMP manufacturing Professionally sound Reliable Innovative Open Respectful Filling, Visual inspection, Labelling, Packing and Distribution

6. Biopharmaceutical development and GMP manufacturing Quality control services (Ph. Eur. / USP) Microbiological analyses Endotoxin Total Protein Purity TOC SDS-PAGE Immunological assays Potency test in mice Professionally sound Reliable Innovative Open Respectful

7. Biopharmaceutical development and GMP manufacturing GLP services Approved by Norwegian Accreditation for GLP toxicity studies Collaboration with the National Lab Animal Centre Single and Repeated Dose Toxicity Test Professionally sound Reliable Innovative Open Respectful

8. Biopharmaceutical development and GMP manufacturing Formulation & Manufacturing & QC for Scale-up &. Process Design Tech Transfer to Laboratory development Preclinical tests Clinical trials Phase 1, 2 & 3 Commercial production NIPH Services in our customers Product development cycle Professionally sound Reliable Innovative Open Respectful

9. When you need a reliable partner within sterile or aseptic formulation and filling for clinical trials (GMP) advise on formulation, manufacturing process, analytical methods biological, microbiological or chemical tests GLP toxicity studies When you just would like to learn more about us and our services Department of Biopharmaceutical production Truls Simensen, MSc Director Tel: +47 23 07 63 10 / +47 91 72 48 33 Mail: truls.simensen@fhi.no Visiting address: Lovisenberggata 6, Oslo, Norway Post: P.O.Box 4404 Nydalen NO-0403 Oslo Norway Please contact us Biopharmaceutical development and GMP manufacturing Professionally sound Reliable Innovative Open Respectful