Company Profile

GlaxoSmithKline Biologicals is a leading company in modern biotechnology. At the Dresden site, formerly the Sächsisches Serumwerk Dresden (SSW), traditional vaccines are manufactured including the flu vaccine, which plays a particularly important role.

Project

In the first phase, LSMW was appointed as the general planning company to design, produce plans, and acquire the approvals required by the Federal Immission Protection Act for a new plant to produce the flu vaccine at the Dresden site.

The factory should be compliant with the EU, GMP, and FDA guidelines. The goal was to increase manufacturing capacity from 35 million to 70 million flu vaccine doses with the new production buildings. In the second phase, LSMW was instructed with the implementation planning, the tenders, the allocation of the technical teams on behalf of the builders, construction management, and also the qualification (IQ / OQ and implementation / monitoring).

The project consists of two L-shaped buildings.

1. The production building in which the flu vaccine is manufactured using egg-based technology. This building houses the complete media generation area in the basement.
2. Building "F" includes logistics (including a high-level warehouse with around 1000 pallet spaces), offices, laboratories, underground parking, as well as an employee canteen.

Key Data

* Branch of SmithKline Beecham Pharma GmbH Co. KG

Measures

• Concept planning
• Draft and approval planning (Bimsch (Federal Emission Protection Act) application)
• Cost calculation +/-15%
• Implementation planning
• Creation of tender documents and allocation on behalf of the builders
• Construction and project management
• Commercial project settlement
• Qualification (IQ / OQ implementation / monitoring)

The above services were used for the following technical teams:

• Process / process equipment
• Clean media
• Process automation
• Ventilation / LAF'S
• Monitoring

Particular Challenges

LSMW could again prove its abilities with the fasttrack implementation of demanding and complex projects.

The ambitious schedule was observed; the plant was constructed in a significantly shorter time than previously comparable GSK projects:

• The concept plan was created within 8 weeks
• The Basic Design, including the overall approval planning in accordance with BImSchG (Federal Immission Protection Act), was completed within 4 months
• The temporary weatherproof building shell was constructed in 7 months
• Total project period from start, concept to end OQ: 36 months

With this investment, GSK's production capacity at the Dresden site was doubled. Flu vaccines are produced in campaigns and must be available on time before the start of the flu season. With the timely operation start in February 2008, all requirements for the Southern Hemisphere flu season 2008 will be met.