FEE&C: Accelerating the Commercialization of Innovative Biologics

Project Background：

As one of the most rapidly aging countries globally, China is facing an increasingly severe challenge with osteoporosis. Osteoporosis is not only one of the leading causes of fractures and other skeletal injuries in the elderly, but its prevalence is also rising rapidly due to the aging population. Traditional treatment methods primarily rely on drugs like bisphosphonates and calcitonin, which have certain limitations, while effective in improving bone density and reducing fracture risk. With continuous advancements in biopharmaceutical technology, innovative therapies are gradually becoming the focal point for osteoporosis treatment.

The client's R&D platform has successfully developed several recombinant monoclonal antibody drugs with potential clinical applications. The emergence of these next-generation treatment options not only provides patients with better choices but also offers a new direction for the medical industry.

Project Info：

• Project Name：Innovative Biopharmaceutical R&D and commercial production project

• Product：Mabs

• Facility type：Greenfield

• Project area：21000 m2

• Project-Driven：Efficiency, Compliance, and Safety

Service Scope：

• Process Design Consulting

• CU & CIP Engineering Consulting

• CCS Strategy

Expectation & Challenges：

• Reliability and Compliance: GMP compliance and high efficiency

• Scalable Production Capacity: 3×3000L SSB + 3×5000L SSB

• Multi-Product Line Evaluation

• Flexible design based on different cell expression

AUSTAR Value：

• Aseptic Engineering Solutions Based on EMA GMP Annex 1

• Class B/C cleaning  classified area layout optimization, HVAC initial investment  control and operating cost control

• CAPEX v.s. OPEX