Solving the Separation Challenge for a Life-Saving Vaccine

Valneva, a biotech company developing innovative vaccines for infectious diseases, is working on a new Lyme borreliosis vaccine. ZETA contributed to the production of the active ingredient by providing a technical solution to a complex downstream separation problem, supporting the development of an urgently needed vaccine. Based on this solution, ZETA engineered and delivered an industrial-scale separation system for operation at a CMO in Amsterdam.

As clinical trials progress, the need for a pure product increased. At laboratory scale, the water-insoluble product is extracted by phase separation with a detergent before further purification by chromatography. However, the phase separation step proved to be problematic even at the 10 L laboratory scale. Water would break through the detergent phase, preventing further downstream processing. Valneva approached ZETA with this phase separation problem.

The ZETA Tech Center was involved to find a technical solution to this problem and to develop a draining strategy suitable for industrial scale production. The efficiency of the separation was monitored by conductivity measurements. A series of draining tests for various special technical installations led to the best technical solution for the separation problem: the use of a peristaltic pump for draining. Initial trials showed stable and reproducible results.

Valneva engaged ZETA to engineer an industrial-scale separation system based on the developed solution to overcome phase separation challenges. Feasibility studies at the ZETA Tech Center enabled scale-up from 120 L pilot to 1,500 L industrial scale. To meet the customer’s need for flexibility, ZETA designed and built a mobile skid consisting of two 750 L vessels. ZETA engineers used 3D modelling to integrate the skid into the existing production area. The skid was equipped with a temperature control unit (TCU), easy to clean agitators and a harvesting system.