CCS Integrated GMP Design for a Multi-product Bio-pharma Facility

AUSTAR engineering design team recently completed a CCS-integrated GMP design project for a Bio-pharma company. The client is a high-tech antibody/recombinant CDMO company and plans to build a multi-product facility including a Mab DS line, sterile filling line, QC lab, PD lab, and warehouse, in compliance with EU and FDA GMP standards.

In the early design phase, our design team learns everything possible about our client’s operation plan, capacity demand, logistics, and quality requirements by clarifying the requirements. The client needs to take the contamination control strategy into consideration in the design phase. Cleaning strategy, production segregation strategy, multi-products facility risk assessment, biosafety risk assessment, etc. are expected to be integrated and documented in the engineering design.

CCS integrated GMP design concept was developed by the AUSTAR design team in consultation with the client’s project team so that the facility could lower operation risk, have high GMP compliance and proper measures to control contamination and be flexible for future expansion.