Bio Deutschland CEO & CFO-Meeting 29. November Unternehmertum in den Life Sciences am Beispiel der Geschichte von Miltenyi Biotec
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1 Bio Deutschland CEO & CFO-Meeting 29. November 2012 Unternehmertum in den Life Sciences am Beispiel der Geschichte von Miltenyi Biotec
2 Major locations Köln
3 Our Passion SHARING OUR PASSION FOR CELLS We are committed to advancing scientific understanding and medicine by providing tools for biomedical research and cellular therapy. Miltenyi Biotec is a truly translational research company
4 Company milestones Foundation of Miltenyi Biotec GmbH
5 Key facts Miltenyi Biotec Germany s largest independent, privately owned Biotech Company Founded in 1989 by Dipl. Phys. Stefan Miltenyi More than 1350 employees in 18 countries More than 250 employees in R&D reagents, engineering & clinical development > 180 Mio. US$ in 2012
6 Key facts Miltenyi Biotec Innovative reagents & instruments for R&D and clinical use Integrated, automated workflow for cell separation, cell analysis and cell culture Cellular therapies for unmet clinical need
7 Key facts Miltenyi Biotec a fully integrated Biotech Company Interdisciplinary R&D teams Physics, Chemistry, Biology, Pharmacy, Veterinary, Medicine, Bioinformatics, Engineering State of the art GMP-manufacturing, Quality Control, Quality Assurance organization Globally operating regulatory affairs, marketing & sales, and technical services organization
8 MACS Technology: The Gold Standard for Magnetic Cell Separation Magnetic labeling Magnetic Separation (elution of the nonlabeled cell fraction) Elution of the labeled cell fraction
9 MACS Technology: The Gold Standard for Cell Separation MACS nanoparticles are approximately 50 nm about the size of a virus
10 Worlwide market leader with > 70 % market share OctoMACS AutoMACS Pro
11 Market expansion Foundation of Miltenyi Biotec GmbH Miltenyi Biotec Inc., Auburn / USA Miltenyi Biotec Ltd., London / UK Teterow Germany Miltenyi Biotec SAS, Paris / France Miltenyi Biotec Srl., Bologna / Italy Miltenyi Biotec S.L., Madrid / Spain Miltenyi Biotec B.V., Leiden / Netherlands Miltenyi Biotec Pty.Ltd., Sydney / Australia Miltenyi Biotec K.K., Tokyo / Japan Miltenyi Biotec Asia Pacific Ptd.Ltd. / Singapore
12 Market expansion Miltenyi Biotec Inc. Boston / USA Miltenyi Biotec Norden A.B., Lund / Sweden Miltenyi Biotec S. Korea Miltenyi Biotec Swiss Miltenyi Biotec China Shanghai / Beijing / Guangdong Miltenyi Biotec Inc. San Diego / USA
13 Miltenyi Biotec - Worldwide Presence & Distribution Direct Sales in 22 Countries Sales through Distributors in additional 34 Countries
14 Employee- and revenue increase
15 Current revenue distribution by regions
16 Portfolio expansion Foundation of Miltenyi Biotec GmbH Amcell Corp. Joint Venture with Amgen Corp. CE-Mark for the CliniMACS System in Europe Aquisition of the branch office in Teterow / Germany incl. Apheresis business Acqusition of the Memorec Stoffel GmbH
17 Portfolio expansion Acquisition of Medic Tools AG, Switzerland Minority investment in nanopet GmbH Distribution contract Viscover Imaging Products Minority investment in Stemgent Inc. with distribution contract Purchase of all substantial assets and employees of Coley, Germany
18 Instrument portfolio the complete solution automacs Pro Separator Sample Preparation Cell Separation gentlemacs Dissociator MultiMACS Cell24 Separator Cell Culture MultiMACS M96 (thermo) Separator MACSQuant Analyzer Cell Analysis Bio-molecule Separation Full integration
19 Optimizing workflows - adding value Sample Preparation gentlemacs tubes & MACSmix Tube Rotator OctoMACS Starting Kit Cell Separation MACS Media & Cytokines MACS Reagents Biomolecule Separation mrna isolation Kit Genomic Services KIR Typing Kit
20 Translational approach in cellular therapy CryoMACS Freezing Bags CliniMACS Reagents MACS GMP Cytokines MACS GMP Media Cryopreservation Cell Material Cell selection Cell expansion or differentiation Quality control Administration to patient Cell culture bags Donor / patient Cell differentiation bags
21 MACS Cell Therapy Clinical Scale Cell Selection: The CliniMACS System Automated sterile cell selection system based on MACS Technology Over cell separation procedures performed More than 800 instruments in the field CE marked since December 1997 for enrichment of CD34 + cells Wide variety of CE-marked reagents for cell enrichment or depletion
22 MACS Cell Therapy Cellular Therapy using the CliniMACS System Hematology / Graft engineering (blood & marrow transplantation) Adoptive immunotherapy Regulatory T cell therapy Ag specific T cell therapy Dendritic cell therapy Regenerative medicine (heart, liver, bone, nervous system, )
23 MACS Cell Therapy Clinical & Regulatory Track Record >200 INDs at US FDA >150 clinical studies in EU & ROW 19 Type II Masterfiles at US FDA > 40 Product dossiers in EU Ongoing HDE registration for CD34 system at US FDA Several ongoing sponsored clinical trials, (most advanced: at Phase III)
24 MACS Cell Therapy Next generation Cell Processing Platform
25 MACS Cell Therapy - the CliniMACS Prodigy Automated cell processing system for GMP cell manufacturing Integrated cell processing from starting material to final cellular product Sample preparation Cell washing & density gradient separation MACS cell separation Genetic modification Cell culture Final product formulation Enabling complex processes Automated & controlled system Closed single-use tubing set Confidential
26 Designed to CliniMACS Prodigy platform =
27 CliniMACS Prodigy platform replace or integrate: =
28 CliniMACS Prodigy platform Closed, sterile, single-use Tubing Set Sophisticated packaging design with mounting aids Straps
29 CliniMACS Prodigy platform Bone marrow-derived CD133 + cells in less than 3 hours 35 min. centrifugation 30 min. incubation 2x35 min. centrifugation 70 min. separation 20 min. centrifugation 35 min. 65 min. 135 min. 205 min. 225 min. Total time 270 min.
30 CliniMACS Prodigy platform Summary Performs complex manufacturing processes in a closed system Integrated cell processing from initial sample to final product Many protocols in development Will make new cellular therapies commercially feasible First projects with major pharmaceutical companies
31 CliniMACS Prodigy Cell Factory
32 CliniMACS Prodigy Cell Factory
33 Complete Tool Box for Cellular Therapy CliniMACS Instruments MACS GMP Antigens CryoMACS Freezing Bags Blood Bone marrow Leukapheresis CliniMACS Reagents MACS GMP Cytokines MACS GMP Media Cryopreservation Donor / patient Cell separation Cell expansion or differentiation Quality Control Flow Cytometry Administration to patient Tissue Sample Dissociation Cell culture bags MACSQuant GentleMACS Cell differentiation bags
34 into 2013 you are all welcome!
35 The Miltenyi team wishes you a peaceful Christmas season and a successful and healthy 2013! Thank you for your attention
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