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Roche Pharma Biotech Production Basel / Facility of the Year Award Winner - Project Execution

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Headquartered in Basel, Switzerland, Roche is one of the world/s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. Their Monoclonal Anti Bodies (MAB) 95 Facility was conceived to provide additional production capacity for the API of Avastin®, a successful new treatment medication used in the fight against cancer.

The primary business driver of this ultra fast-track project was to make this innovative product available to patients as quickly as possible. To do so, Roche expertly planned, designed, and constructed a unique vertical MAB facility on the site of a former chemical production plant in a busy residential area of Basel. By industry standards, the timelines were exceptional for a project of comparable size, complexity, and environmental sensitivity. Standing 40 meters tall with eight floors above ground and two floors underground, the small building footprint and absence of adjacent construction lay-down areas tested the ingenuity of the project team at every turn. (For example, the construction staff occupied a project office located on an elevated platform over the main public roadway.) To reduce congestion in and around the already tight project site, cutting-edge communication technology was applied whenever possible in the day-to-day running of the project. Extensive use was made of video conferencing, documentation was exchanged via the Internet prior to joint reviews, site access was restricted to key personnel, and all project participants were encouraged to conduct as much communication as possible through electronic media. As the facility had to be arranged vertically, and as all systems are fully integrated, the normal option of sequential completion proved to be too slow when modeled in the schedule. This forced the project team to develop the tactics necessary to complete the whole facility as a single entity (i.e., work on everything in parallel). The project team competently faced this and other project challenges with a "no blame, fix the problem" mentality.

Through teamwork, innovative design, and precise construction management, this state-of-the-art project was successfully realized in only 35 months, six weeks ahead of an already aggressive schedule and nine percent under budget.

Blogs

The Tale of Two Deviations

The Tale of Two Deviations

Apr 23 | The QA Pharm

It stands to reason that pharmaceutical companies in compliance trouble also have problems with their Deviation Management and Corrective and Preventive Action (CAPA) System(s).

Can the Combination of Creative Destruction and “Steve Jobs’ Traits” Lead to a “Pharma QbD Spring”?

Can the Combination of Creative Destruction and “Steve Jobs’ Traits” Lead to a “Pharma QbD Spring”?

Apr 16 | Girish Malhotra, PE, President, EPCOT International

The answer is an unequivocal yes but we need some outsiders who can conspire with the insiders who will be the flag bearers within the companies. Outsiders can be the counsels/co-conspirators to the insiders for the coup d'etat.

Multimedia

Lung Cancer Drug Treats Rare Lymphoma Tumors

Lung Cancer Drug Treats Rare Lymphoma Tumors

May 17 | Video

A new study found Xalkori effective in treating anaplastic lymphoma among children, an encouraging development for gene-targeted therapy.

Merck - 2012 Facility of the Year Award - Facility Integration

Merck - 2012 Facility of the Year Award - Facility Integration

May 14 | Video

Brian Morrissey, Senior Project Engineer, Merck Manufacturing Division, talks to Pharmaceutical Processing's Editor In Chief Mike Auerbach during INTERPHEX 2012 about the company's Vaccine Bulk Manufacturing Facility Program of Projects. The facility has won the Facility Integration award in the 2012 Facility of the Year Award competition sponsored by ISPE, INTERPHEX and Pharmaceutical Processing magazine.

Medicine from a Vending Machine?

Medicine from a Vending Machine?

May 3 | Video

A Chinese company is pushing for acceptance of traditional Chinese medicine with a machine that can dispense herbs.

Taking Precautions to Prevent Contagion

Taking Precautions to Prevent Contagion

Apr 29 | Video

With the recent outbreak of viruses such as SARS, bird flu and swine flu, officials and travelers are being extra careful about preventing the illnesses from being transmitted.

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