Tofflon Best Engineering Practice for Large-Scale mAbs Commercial Manufacturing

Monoclonal antibodies (mAbs) have been widely used in various applications in diagnosis and therapy for several diseases such as cancers, autoimmune diseases, sexually transmitted infections (STIs) and others. After COVID-19 Epidemic, many emerging markets and industry leaders speed up biopharmaceutical products manufacturing investment including mAbs for local market and international markets. How to rapidly and successfully build an advanced, high-quality and cost-competitive bio manufacturing facility is high demand for many biopharma companies? In Achema 2024, Tofflon is going to present you Our Best Engineering Practice to demonstrate how we help a customer to build Large-Scale mAbs Commercial Manufacturing Facility.

• Project Pipeline

Multiple commercial products for mAb, recombinant protein and other biopharmaceutical products

• Regulatory Compliance

In compliance with global cGMP regulations like US FDA, EMA and China GMP.

• Cell Culture Capacity

-??????? 60,000L with 12 x 5,000L bioreactors.

-??????? Fully integrated production facility that offers process development, drug substance manufacturing and drug product fill and finish services at a single location.

• Development Stage: Commercial
• From Concept to Completion of Mechanical Work: 12 months
• Tofflon’s Main Scope

-??DS-UPS: 12 x 5,000L main bioreactors and relevant seed bioreactors, Media/Buffer/CIP/TCU Skids as well as Freezing & Thawing System, Waste Water Inactivation System.

-??DS-DPS: Chroma System and Columns and UF/DF/VF Systems.

-???DP: 1 x Liquid Vial Filling Lines with Aseptic Isolator (400VPM@2ml Vial) + 1 x Lyo Vial Filling Line with Aseptic Isolator (400VPM@2ml Vial) + 2 x LYO-25(SIP,CIP) + 2 x Secondary Packaging Lines (400VPM@2ml Vial)

-??Siemens PCS 7 DCS

-??Qualification and Validation ?

• ? Project Demand

-???Global Regulatory Compliance

-???Satisfied Process

-???Successful Engineering

-???Cost-Competitive Production

-???Easy Operation and Maintenance

• Tofflon Strong Technical Suppor

• Tofflon Best Engineering Practice

-?? Gravitational Flow Design To Minimize Production Loss.

-???Black/White Area Separation To Reduce Cleanroom Area.

-??????? CIP/SIP Strategy To Maximize Production Shift Flexibility.

-??????? Media/Buffer Distribution Strategy To Offer Process Flexibility.

-????3D Pipework Design to minimize equipment interface risk and improve efficiency of equipment operation and maintenance.

-???BIM Design For Interconnecting Pipelines To Prevent Pipe Interference And Guarantee Pipe Slope And The lowest Point.

-???Equipment Modular Design and Installation

-?? DCS is used for DS System to realize centralized control and data management.

-????Central SCADA for DP System to realize data collection and data backup.

-?? Qualification and Documentation throughout the whole project lifecycle.

For more detailed information ,weclome to join us on Tofflon Stand Hall3.0 A25, Achema 2024 ,Frankfurt ,Germany.

or send email to [email protected]

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