ZETA delivers cutting-edge ADC downstream processing system in record 18 months.

Innovative skid-based design and precision engineering enable safe, GMP-compliant production of high-value antibody-drug conjugates in Switzerland.

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Record achieved. Project realization in just 18 months.

ZETA successfully delivered a state-of-the-art downstream processing system to produce antibody-drug conjugates (ADCs) to a client in Switzerland – achieving this milestone in a record-setting timeframe of just 18 months. The project was a perfect example of how a prefabrication and skid concept can be implemented even for 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. Sophisticated technical solutions were necessary to manage both sensitive and hazardous substances and to ensure optimal product integrity and minimize the loss of highly sensitive and exceptionally 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

Downstream technology at its best

The plant includes two production lines, space for another line, a common buffer preparation and storage system, a common freeze and thaw area, plus all the required supporting functions. It is compliant with all safety regulations and GMP standards and features an operator-friendly plant design. Because of the special safety measures required for handling the toxic ingredient, the facility is separated into independent operation units. During the functional FAT, the customer had the opportunity to perform comprehensive tests. ZETA provided a perfect test environment with all the necessary media available. The result was the perfect optimization of software and functions.

Ultimate safety in downstream processing

Carefully thought-out and highly customized solutions allow downstream processing at a supreme level. Controlled freezing, transport, storage and thawing of the sensitive substances were effectively accomplished by a customized solution based on the ZETA Freeze & Thaw Systems. A secure and complete product transfer is ensured by special, magnetically driven pumps. Furthermore, to avoid product losses, a best-in-class vessel geometry was developed for ultrafiltration.

Products Freeze & Thaw

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.

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Andreas Glössl

Senior Director Business Line Customised Systems

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