Plants for the Pharmaceutical Biotechnology
The production of active pharmaceutical ingredients using biotechnological processes, including genetic engineering, is a young, dynamically developing branch of the industry.
The biotechnological process steps of synthesis (fermentation), processing and high-purification (down-stream processing) of active substances differ considerably from the chemical syntheses. The technological solutions are as innovative and new as the branch of industry is. With the Biotechnology, a completely new area of dimensioning in process engineering and plant design has been generated now shaping a whole generation of engineers.
As from the beginning of the growing importance of the industrial scale application of biotechnology in the European pharma industry, Linde-KCA-Dresden has played a pioneer role. The biotechnology demands an extremely close connection of product and plant development. Linde-KCA-Dresden was prepared to cope with this trend. That way, Linde-KCA-Dresden cooperated in the process development for the production of Hepatitis-B-Vaccine and developed a specific "Front-End Engineering" approach (PDF, 269,5Kb), that constitutes an efficient approach to minimize the risk of biotechnology projects.
Our engineers have gained experience in planning of biotechnological plants, in particular gene technological plants that are characterized by the key criterion sterility beginning from processes based on yeast and bacteria up to processes on the basis of animal cell cultures modified by genetic engineering.
Selected references
Example 1
Cell culture plant for production of MAB
Client:
F. Hoffmann-La Roche AG
Location:
Basle / Switzerland
Type of plant:
New cell culture plant for production of monoclonal antibodies (MAB)
Product:
Anticancer drug Avastin
Scope of work: Project coordination Concept design, basic design, detail design Support in procurement Engineering support during installation and commissioning |
Commissioning:
2007
Example 2
Revamp of an Insulin plant
Client:
Novo Nordisk A / S
Location:
Kalundborg / Denmark
Type of plant:
Plant for the final Purification of an Insulin Analogue (PIA)
Product:
Recombinant insulin analogue
Production process:
Insulin purification
Scope of work: Detail-Engineering Procurement Construction Management Commissioning Qualification |
Planning Period :
2006 / 2007
Example 3
Biotechnological plant for the production of EPO
Client:
Roche Diagnostics GmbH
Location:
Penzberg / Germany
Type of plant :
New cell culture plant on a scale of 5.000 l
Product:
EPO (Erythropoietin)
Scope of work: Concept design Basic design Detail design Support in procurement Design support during construction Qualification support |
Commissioning:
2005
Example 4
One of the world's largest biopharmaceutical capital investments - Wyeth BioPharma Campus Dublin
Client:
Wyeth Medica Ireland
Location:
Grange Castle Campus, Dublin / Ireland
Product:
ENBREL® Pneumococcal Conjugate Vaccine
Type of plant: Drug development Drug substance Finished products |
Scope of work: Consulting during Integrated Construction and Validation (ICV) Work on Acceleration program, introduction of shift work up to 24/7, de-bottlenecking Set-up of overall real time tracking system for all ICV activities |
Planning period :
2003 / 2004
Example 5
Insulin plant
Client:
Aventis Pharma Deutschland GmbH
Location:
Frankfurt (Main) / Germany
Type of plant:
General planner for design and construction of the plant for the production of insulin glargine (trade name Lantus®)
Product:
Recombinant insulin analogon with depot effect
Production process:
Biotechnological fermentation
Scope of work: General planner for design and construction, engineering „Lump sum“ Basic and detail engineering, procurement (on behalf and on account), civil and construction, commissioning, qualification |
Start-up:
2002
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Weitere Referenzen
Impfstoffe
Planung einer neuen Anlage zur biotechnologischen Herstellung von drei Impfstoffen für GlaxoSmithKline Biologicals Kft in Gödöllö (Ungarn), 2003
Rekombinante Blutgerinnungfaktoren
Planung einer Produktionsanlage zur Herstellung des rekombinanten Blutgerinnungfaktors VIII durch die Bayer AG in Wuppertal (Deutschland), Know-how- und Technologietransfer aus Forschung/Entwicklung/Produktion in kleinem Maßstab auf eine industrielle Großanlage, Konzeptstudie, 2001
