Plants for the Pharmaceutical Biotechnology

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

Location

Type of plant

Product

Production process

Scope of work

	Detail engineering
	Procurement
	Construction management
	Commissioning
	Qualification

Planning period

Example 3
Biotechnological plant for the production of EPO

Client

Location

Type of plant

Product

Scope of work

	Concept design
	Basic design
	Detail design
	Support in procurement
	Design support during construction
	Qualification support

Commissioning

Example 4
One of the world's largest bio­pharmaceutical capital investments - Wyeth BioPharma Campus Dublin

Client

Location

Product

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
	-	Improved control of execution
	-	Risk reduction

Planning period

Example 5
Insulin plant

Client

Location

Type of plant

Product

Production process

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

Further references

Vaccines

Planning of a new plant for the biotechnological production of three vaccines for GlaxoSmith Kline Biologicals Kft. in Gödöllö (Hungary), 2003

Recombinant coagulation factors

Planning of a plant for the production of the pharmaceutical ingredient in high-cell-density perfusion cultures of BHK cells and purification of the glycoprotein for the Bayer AG in Wuppertal (Germany), know how and technology transfer from production and R&D into design basis, conceptual design for all disciplines, 2001

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