Polpharma centralized their biotech activities at the Biologics R&D centre located in the Gdańsk Science and Technology Park. In the facility, the company develops biosimilar medicines in order to ensure better access to effective therapies for patients suffering from serious diseases. The Polpharma Centre with an area of 2,600 m² houses R&D laboratories and a GMP pilot plant for the production of biopharmaceuticals.
Polpharma contracted io-consultants for project management and process engineering to retrofit an existing facility with process equipment for drug substance production. Process equipment is almost exclusively single use technology.
After completion of concept and basic design, the main scope of work was to specify and procure process systems and equipment for drug substance manufacturing operations.
io-consultants implemented one 1.000 L bioreactor with an option for a second 1.000L bioreactor. Consecutively, a validation master plan was created, and qualification services were provided jointly with Polpharma biologics’ staff. In order to efficiently integrate the specified single use equipment, io-consultants designed a disposable assembly kit. The Single Use Assembly Kit was designed in a modular concept to fit a generic production process and helped to minimize manual configuration of process assemblies during production.
Furthermore io-consulltants developed a storage and manufacturing logistics concept including a suitable IT architecture.
io-consultants was contracted to specify and procure the required process equipment for drug substance manufacturing operations.