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Biopharmaceutical Production

Biopharmaceutical development and GMP manufacturing. Biopharmaceutical Production. Professionally sound Reliable Innovative Open Respectful. Biopharmaceutical development and GMP manufacturing. Development, Manufacturing and Quality control

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Biopharmaceutical Production

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

  4. Biopharmaceutical development and GMP manufacturing 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 39 comprehensively educated and trained employees Several hundred years of experience within GMP processing of biological substances Professionally sound Reliable Innovative Open Respectful

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

  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 NIPH Services in our customers Product development cycle Formulation & Manufacturing & QC for Scale-up & . Process Design Tech Transfer to Laboratorydevelopment Preclinical tests Clinical trials Phase 1, 2 & 3 Commercialproduction Professionally sound Reliable Innovative Open Respectful

  9. Biopharmaceutical development and GMP manufacturing Please contact us • 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 Professionally sound Reliable Innovative Open Respectful

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