Detailed Design of Manufacturing Facility, Facility Implementation Variations

Synertec provided a turnkey Engineering, Procurement and Construction Management (EPCM) service, including certification to upgrade Gropep’s Bacterial Fermentation and down stream processing facilities.

“The upgrade to the manufacturing facility will provide GroPep with sufficient capacity to meet demand for Cell Culture Products for at least the next 5 years,” said Dr Chris Goddard, the Company’s Chief Operating Officer.

GroPep is a world leader in the development, manufacture and commercialisation of biologically active proteins for cell culture and biomedical research. The Adelaide-based company has an active biopharmaceutical drug development program that establishes proof of concept for products in humans and partners the later stages of product development and marketing with major pharmaceutical companies.

Synertec project managed the upgrade including the addition of 200m² of Clean Room space and a significantly enhanced Purified Water system as well as an extensive refurbishment of existing manufacturing facilities and an expansion of office facilities.

Gropep’s stated criteria for this project were quality of design and construction, no interruption to manufacturing and a certified outcome that was guaranteed.

Synertec planned the staging of construction activities around the requirements of the Production departments so that no production days were lost. This required extensive communication and coordination with all stake holders from Senior Management, Quality Assurance, Production, Contractors, Subcontractors and the Environmental Protection Agency (EPA).

The quality improvements arising from this project underpin GroPep’s compliance with current Good Manufacturing Practices (cGMP). The facility is of the highest quality and functionality and Gropep was able to satisfy its commitments to continue to supply product throughout the construction period.

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