Higgyhly Potent APIs „Made by Heraeus“
Dr. Friedrich Wissmann Pharmaforum, Frankfurt, Nov. 3rd, 2009
W.C. Heraeus GmbH; Chemicals Division; Business Unit Pharmaceutical Ingredients – Pharmaforum 3.11.2009 Page 1 The Heraeus Group at a Glance Key financial indicators 2008
Heraeus
Product revenue Precious metal trading revenue Employees at year-end €2,920 million €12,994 million 12,830
Dental and Specialty Lighting Precious Metals – Sensors – Medical Products – Quartz Glass – Sources – W. C. Heraeus Heraeus Electro-Nite Heraeus Kulzer Heraeus Quarzglas Heraeus Noblelight
Product revenue in € million
1,881.3 377.3 346.6 213.0 92.5
Employees
4,824 3,462 1,656 1,606 735
W.C. Heraeus GmbH; Chemicals Division; Business Unit Pharmaceutical Ingredients – Pharmaforum 3.11.2009 Seite 3 Organization Structure W. C. Heraeus GmbH
DiiiDivisions
Chemicals Contact Materials Engineered Materials Medical Components Thick Film Materials Thin Film Materials Trading CHD CMD EMD MCD TFD TMD TRD
Business Units Assembly Electro Assemblies & Ceramic Catalysts Electronics CA AM MtMateri ilals ET ThlTechnology AC Co iling CC ClColours ELC
Chemical Bonding Functional Materials & Large Area Photovoltaic CP Products BW Wires FM Materials MM Machining PV LAC Coating
Pharma- Magnetic PkiPackaging Wire ceutical Thick Film Data PI PT Technology WP Processing TH MDS Ingredients Storage Precious RC Recycling PM Metals Technology Special ST Metals Technology
W.C. Heraeus GmbH; Chemicals Division; Business Unit Pharmaceutical Ingredients – Pharmaforum 3.11.2009 Page 4 W. C. Heraeus
Locations Worldwide Sweden: • Sollentuna Germany: Denmark: • Hanau • Hilleroed • Potsdam Czech Republic: Austria: • Prague • Vienna Russia: • Moscow Italy: • St. Petersburg • Milan Ukraine: Japan: Great Britain: •Kiev • Hertfordshire •Tokyo • Stoke-on-Trent Belarus: • Tsukuba •Minsk Ireland: Korea: • Shannon Poland: • Incheon •Warsaw Switzerland: China: • Yverdon Hungary: Turkey: • Changshu • Thalwil • Gödöllö •Izmir • Danyang • Mendrisio Croatia: • Hong Kong France: • Zagreb • Shanghai USA: • Shenzen • Courtaboeuf Romania: • Chandler • Grésy-sur-Aix • Zhaoyuan • Newark / New York • Bucharest Spain: Taiwan: • Santa Fe Springs Bulgaria: India: • Madrid • Taipei • St. Paul •Sofia • Udaipur • West Conshohocken • Varna • Wartburg Indonesia: • Tangerang Puerto Rico: • Serang • Dorado The Brazil: Philippines: • São Paulo •Cavite South Africa: Singapore: • Dunswart • Singapore • Port Elizabeth Production Facility Kazakhstan: • Almaty Sales Facility
W.C. Heraeus GmbH; Chemicals Division; Business Unit Pharmaceutical Ingredients – Pharmaforum 3.11.2009 Page 5 Heraeus Core Competencies in hig hly po ten t API syn thes is
BiBusiness U UitPhnit Pharmaceuti tilIcal Ingredi ditents Our Business Activities
Generic Branded hAPIs hAPIs
Expertise in anti- cancer APIs
Global Process services Development
W.C. Heraeus GmbH; Chemicals Division; Business Unit Pharmaceutical Ingredients – Pharmaforum 3.11.2009 Seite 7 Generic hAPIs
Cisplatin Carboplatin Oxaliplatin
Dacarbazin Thiotepa
Epirubicin Idarubicin
W.C. Heraeus GmbH; Chemicals Division; Business Unit Pharmaceutical Ingredients – Pharmaforum 3.11.2009 Seite 8 Branded hAPIs
Full support through all pre- clinical and clinical phases Exclusive R&D Scale-uppp and pilot-scale under full cGMP CMC-section filing Exclusive commercial production Strict protection of customer IP
W.C. Heraeus GmbH; Chemicals Division; Business Unit Pharmaceutical Ingredients – Pharmaforum 3.11.2009 Seite 9 Global services
Worldwide sales Consultancy services network and for EU, USA and Japan professional logistics All product releases by Qualified Person DMFs and CEPs filed in Europe, USA, JJAtlidapan, Australia and Strong Regulatory further regions Affairs group
W.C. Heraeus GmbH; Chemicals Division; Business Unit Pharmaceutical Ingredients – Pharmaforum 3.11.2009 Seite 10 Development services
All R&D in fully glove boxed systems Working range from ml to 70 L in R&D for chemical and mircobiological processes All R&D under full cGMP Analytical development and validation inhouse Qualification of reference standards
W.C. Heraeus GmbH; Chemicals Division; Business Unit Pharmaceutical Ingredients – Pharmaforum 3.11.2009 Seite 11 Technology platforms
Precious metal Organic chemistry chemistry
Expertise in anti- cancer APIs
Downstream Fermentation processing
W.C. Heraeus GmbH; Chemicals Division; Business Unit Pharmaceutical Ingredients – Pharmaforum 3.11.2009 Seite 12 Heraeus – Expertise in hAPI Synthesis Technology Portfolio
Beg 70s 1982 1996 2009
Cisplatin (tech.) Production
Pt based Anticancer hAPI Production
Organic Anticancer hAPI Manufacturing
Fermentation Based hAPI Manufacturing
W.C. Heraeus GmbH; Chemicals Division; Business Unit Pharmaceutical Ingredients – Pharmaforum 3.11.2009 Page 13 Precious metal chemistry
Worldwide leader for generic platinum APIs
Production capacities exceeds ton-scale
All production in class D cleanrooms
Safe supply by multiple producti on f aciliti es
Professional precious metal handling incl . internal refining services
W.C. Heraeus GmbH; Chemicals Division; Business Unit Pharmaceutical Ingredients – Pharmaforum 3.11.2009 Seite 14 Organic chemistry
Fully closed reactor trains to meet highest safety standards
Production capacities from 20 L to 2 cbm; all glass-lined equipment
Capable to handle chlorinated solvents and highly corrosive reagents
Equipment designed to be combined with fermentation up- or/and downstream
W.C. Heraeus GmbH; Chemicals Division; Business Unit Pharmaceutical Ingredients – Pharmaforum 3.11.2009 Seite 15 Fermentation
Han dling of modifi ed organi sms (class S2)
Master cell banks from our biotech cooperation partners indvidually stored (-70°C) at muutpeltiple locatio ns
Fermenter volumes ranging from 10 L to 3000L (total: > 6000 L)
Development and testing laboratory up to Risk Class S2
„Herstellerlaubnis“ issued by the RP Darmstadt in 2009
W.C. Heraeus GmbH; Chemicals Division; Business Unit Pharmaceutical Ingredients – Pharmaforum 3.11.2009 Seite 16 Downstream proccesing
All handling in closed systems or glove boxes to meet highest ppqrotection requirements
Fermentation products purified by extraction, cristallization, and reverse osmosis
GL equipment for chemical modification of intermediates
Preparative HPLC for polishing intermediates or final product (30 cm columns)
Working permit for chlorinated solvents
W.C. Heraeus GmbH; Chemicals Division; Business Unit Pharmaceutical Ingredients – Pharmaforum 3.11.2009 Seite 17 Overall Summary
Heraeus is the expert for the synthesis of highly potent APIs by chemical or microbial pathways.
We meet the industries needs for gram amounts as well as for full scale commercial supply. All work is performed under full cGMP.
Weperform chilhemical / mibilicrobial process dldevelopment under high est safety and cGMP requirements. Analytical development is done in- house.
We back our products by support in all technical, regulatory and IP matters.
All our products are well accepted in EU, USA, Japan and Australia. We are FDA approved since 1988.
W.C. Heraeus GmbH; Chemicals Division; Business Unit Pharmaceutical Ingredients – Pharmaforum 3.11.2009 Seite 18 Thanks for your attention!
W.C. Heraeus GmbH Chemicals Division Business Unit Pharmaceutical Ingredients Heraeusstr. 12-14 63450 Hanau / Germany
Phone: +49 6181 35 5445 Mail: [email protected]
www.heraeus-pharma.com
W.C. Heraeus GmbH; Chemicals Division; Business Unit Pharmaceutical Ingredients – Pharmaforum 3.11.2009 Page 19