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References - BioPharmaceutical Plants (PDF 1120 KB)
Linde-KCA-Dresden GmbH References in Biotechnology Postal address: Postfach 21 03 53 01265 Dresden, Germany House address: Bodenbacher Straße 80 01277 Dresden, Germany Linde-KCA-Dresden GmbH Section Pharmaceutical Plants Phone: Fax: E-Mail: Internet: +49 3 51 250 3707 +49 3 51 250 4814 lkca.pharma@linde-kca.com www.linde-kca.com Examples of References: Biotechnological Plants Pharmaceutical Plants Project LANTUS ® Insulin, Aventis Pharma ■ Client Aventis Pharma Deutschland GmbH ■ Location Frankfurt/M., Germany ■ Type of Order Plant for the production of the insulin derivative Insulin Glargine (trade name Lantus ®) ■ Product Recombinant insulin derivative with depot effect due to engineered amino acid sequence ■ Scope of Work ◆ ◆ Engineering „Lump sum“ (appr. 25 Mio. €) Basic and detail engineering, procurement (on behalf and on account), civil engineering, mounting, commissioning, qualification ■ Production Process Biotechnological fermentation ■ Total Investment appr. 150 Mio. € ■ Handover 2002 LINDE-KCA-DRESDEN GMBH Pharmaceutical Plants Plant for the Fractionation of Human Blood Plasma ■ Client Aventis Behring GmbH ■ Location planned for Marburg, Germany ■ Type of Plant Plant for the fractionation of human blood plasma ■ Products Basic fractions of human blood plasma and products of down stream processing ■ Total Investment 160 Mio. € ■ Scope of Work Concept and (3,7 Mio. €) basic engineering for process, architecture, civil engineering, infrastructure, IT LINDE-KCA-DRESDEN GMBH 2 Examples of References: Biotechnological Plants Pharmaceutical Plants Biotechnological Production of Recombinant Factor VIII ■ Client Bayer AG, Leverkusen C ■ Location Germany, planned for Wuppertal-Elberfeld +31,30 +30,45 Piping BR- BrandgasVentilator Klappen RA03BA01 Korridor Nat/DV CIPIso. Doppelboden /F90 Piping 35m³ DurchhangRa0M edienLagerung 1PA01 HVAC HVAC HVAC Piping Abgeh. begeh.Decke 2c MediaPrep. 2b Pumpen Skid +17,85 Cubicals +13,65 2a Fermentation 1c Piping ÜBERGABE Büro Ferm/Puri Zentrifugation +9,45 Kor 200L-Fermentation Ver rohrung Isolation TEC 007 Armaturenrack TEC 008 Ver rohrung mit WT A rmatur enrack RA01BA01 4,0m³ RA01FF01 BRKlappen Erntelagerung200L -Ferm. +12,60 +22,05 Be tr.-Ing. Piping +26,45 Reserve 3a BRKlappen RA03BA01 Abgeh.35mb³egeh.Decke Piping BrandgasVentilator 3a MediaPrep. Re serve BrandgasVentilator +16,80 HVAC Med.Prep +22,05 2b 3b HVAC Purifi MedienLagerung Arm atu re nr ack BA07BA01 4,0m³ Arm atu re nr ack Pufferansatz, Isolation 2c HVAC HVAC BA07FG01 Rohrleitungsbere ic h 3a IsoPrep. Arm atu re nr ack RA01BA01 6,3m³ Arm atu re nr ack +26,45 TEC 026 Abgeh. begeh.Decke 3b HVAC 1c 2c 2b Ferm/Puri Betr.-Ing +9,45 +5,25 2a Büro 1c Büro +4,20 Korridor Pumpe Wärmetauscher KL01 EG01 BA01PA02 V644 und V645 BA01PA01 KL03 PA0 2 XX01 KL03 PA0 3 V632 KL01 KL03 PA0 4 KL01PA0 1 ±0,00 KL02PA0 1 +0,10 KL03PA0 1 Kälte- /Wärmeträger 1a Utilities Wassersysteme Pumpe V644 BA01BA01 PA03 BA01PA01 V644 UtilitiesHalle 1a Utilities 1a Parken ±0,00 +0,10 Architectural design: Koppenhöfer ■ Scope of Work ◆ ◆ ■ Product Recombinant blood coagulation factor VIII Know how and technology transfer from production and R&D into design basis Conceptual design for all disciplines ■ Type of Plant Plant for the production of the pharmaceutical ingredient in high-celldensity perfusion cultures of BHK cells and purification of the glycoprotein ■ Total Investment appr. 160 mio. € ■ Planning Period December 2000 - June 2001 LINDE-KCA-DRESDEN GMBH Multipurpose Plant for the Production of Steroid Agents ■ Client Schering-Jenapharm ■ Location Jena / Germany ■ Type of Order Turnkey plant in compliance with GMP regulations; EPCM including qualification ■ Biotechn. Process Steps Stereospecific transformation of steroids, Fermentation and Downstream processing ■ Capacity 2 Pilot fermenter a 500 l, 2 Production fermenter a 10.000 l ■ Commissioning 1995 3 Examples of References: Biotechnological Plants Biotechnological Production of Hepatitis B Surface Antigen (HBsAg) ■ Type of Order Process development ■ Partner and Process Supplier Rhein Biotech, Düsseldorf, Germany ■ Scope of Work Concept for the transfer of the laboratory process to production scale, financing, planning und construction of the pilot plant; assistance during the runs of the pilot plant and in the preparation of the development report; concept of a production process in compliance with GMP ■ Capacity 50 Liters per batch; equivalent to 15 mio doses/a ■ Planning Period 1998 ■ Result Marketable procedure; e.g. license contract issued to Pasteur-Merieux-Connaught; authorisation for Argentina LINDE-KCA-DRESDEN GMBH Plant for Fractionation of Human Blood Plasma ■ Client Biotest Pharma GmbH ■ Location Dreieich / Germany ■ Type of Order New plants for the fractionation of blood plasma and the production of blood coagulation factors ■ Products Immun Globulines, Human Albumines and Blood Coagulation Products ■ Scope of Work Qualification, project management and controlling, engineering, site coordination, controlling ■ Planning Period 2001 and 2002 LINDE-KCA-DRESDEN GMBH 4 Examples of References: Biotechnological Plants Pharmaceutical Plants Biotech Performance Park Leuna ■ Client INFRALEUNA Infrastruktur und Service GmbH ■ Location Leuna / Germany ■ Type of Order Consulting service for a biotech park ■ Result Finished fast track conceptual design with cost estimate ■ Planning Time 3 Weeks in 2002 ■ Scope of Work ◆ Elaboration of user requirements and design basis ◆ Conceptual design studies of two biotech multipurpose plants ◆ Park development concept LINDE-KCA-DRESDEN GMBH Pharmaceutical Plants Plant for the Production and Packaging of Antibiotics ■ Client ENZIM, Ladyzhin ■ Location Ladyzhin / Ukraine ■ Product Antibiotics (lyophilisate) ■ Type of Order New plant, consisting of - product lines for sublimation drying - sterile packaging - water treatment plant (high purity) Preparation of the antibiotic solution ■ Scope of Work Turnkey plant in compliance with GMP ■ Completion 1998 LINDE-KCA-DRESDEN GMBH 5
