51ÁÔÆæ

Background

A biological drug development company based in Europe came to 51ÁÔÆæ as their facility expansion was under construction. A team of 51ÁÔÆæ experts engaged in guiding this company through the entirety of its planning, qualification, engineering and management stages. 51ÁÔÆæ was challenged with bringing this facility to effective operation while meeting all US, EU and other international compliance requirements, within project timeline.

51ÁÔÆæ Approach

51ÁÔÆæ experts collaborated with the client engineers to support and assist in a customized design and build out of a microbiology and physical chemistry laboratory, in which its up-and down-steam fermentation processes were used. 51ÁÔÆæ reviewed conceptual designs for the following areas including Facilities and utilities, Environmental Monitoring, Building Management System, and Extension of Clean Media Automation System.

51ÁÔÆæ ensured all design specifications and qualifications for Technical Systems and USP processes were in place to support this design of the facility.

51ÁÔÆæ provided the client with a design review and documented findings, with a list of compliance statuses and risks. All items were addressed with the client, action plan developed and executed including recommendations for:

• Segregation of manufacturing activities, including pre- and post-viral inactivation sections.
• GMP Water systems supporting each stage of the manufacturing process.
• GMP Clean Steam systems supporting each stage of the manufacturing and sanitation processes.
• Steam In Place system.
• Site Validation Master Plan.

51ÁÔÆæ provided the guidance and technical management roles, to support the Quality Management System requirements for FAT/SAT/IQ/OQ/PQ.

Results

51ÁÔÆæ assisted in leading this client through a very enduring design and build of a Biologics Facility. With QA, cGMP and Validation expertise provided by 51ÁÔÆæ this client was able to navigate through all compliance and regulatory challenges. Aligning strategy, leadership and proven industry experts to address FDA, global regulatory and operational related issues, 51ÁÔÆæ provided a customized plan of action with experienced resources to meet our client’s specific requirements and goals.