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ZETA USA| Success Stories | High-Tech Plant for Antibody-Drug Conjugation
From to ZETA
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High-Tech Plant for Antibody-Drug Conjugation

ZETA delivers an ADC downstream processing system in 18 months.
Skid-based design and precision engineering support safe, GMP-compliant production of antibody-drug conjugates in Switzerland.
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Record achieved. Project realization in 18 months.

ZETA delivered a downstream processing system for antibody-drug conjugate (ADC) production to a client in Switzerland within 18 months. The project demonstrates how a prefabrication and skid-based concept can be applied to complex monoclonal antibody and cytotoxin downstream processes.

The challenge

The production of ADCs must meet the most exacting demands on process technology – especially with regard to the critical conjugation step between antibody and toxin. Technical solutions were required to manage sensitive and hazardous substances, ensure product integrity, and minimize loss of valuable compounds.

 

 

Mastered challenges.

Customized solution

Controlled freezing, transport, storage and thawing of the sensitive substances effectively accomplished.

Efficient cooling

Development of a specific vessel geometry for ultrafiltration.

Vessel cleanability

Spray ball design and cleaning procedure ensured complete toxin removal.

The solution

3D-image of production plant, including platform with stairs, vessels, piping, cabinets
Complexity in design is managed by streamlining 3D modeling – basic design elements are created, duplicated, and individually adapted to optimize efficiency and flexibility.
Large production skids made of stainless steel in fabrication hall, including vessels and complicated piping and wiring
The user-friendly plant design enables easy access to process units and fast maintenance via dedicated workshop platforms.

Downstream processing technology

The system includes two production lines, space for an additional line, a shared buffer preparation and storage system, a common freeze and thaw area, and supporting functions. It is compliant with all safety regulations and GMP standards and features an operator-friendly plant design. Due to safety requirements for handling toxic components, the system is organized into independent operational units. During the functional FAT, the customer had the opportunity to perform comprehensive tests. ZETA provided a test environment with the necessary media available. The result was optimized software performance and system functionality.

Ultimate safety in downstream processing

Customized solutions support advanced downstream processing. Controlled freezing, transport, storage and thawing of the sensitive substances were effectively accomplished by a customized solution based on the ZETA Freeze & Thaw Systems. Secure product transfer is supported by magnetically driven pumps. Furthermore, to avoid product losses, an optimized vessel geometry was developed for ultrafiltration.

Download the Full Article Freeze & Thaw Systems

Engineering Safe and Scalable ADC Manufacturing Systems

Integrated downstream processing systems for high-containment biopharmaceutical manufacturing environments.
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