Lonza expands biologics manufacturing capacity
Practice-compliant facility for the production of microbially
derived biopharmaceuticals at its largest worldwide production
centre in Visp, Switzerland.
Following the completion of construction and successful qualification and validation, commercial production activities commenced in mid-September, said the company.
The single-train facility, which has a working fermentation volume of 1,000 liters, has been designed to be adapted to multi product requirements. The heart of the installation consists of a 1,000 liter bioreactor plus primary product recovery and protein purification facilities. The installation is equipped to handle products secreted by microorganisms as well as intracellular products, and is also suitable for culturing microorganisms that require organic solvents.
Essential items of infrastructure, such as ultra pure water and ultra pure steam supplies, have been expanded, and supporting functions such as quality management, quality control and research & development have also been extended.
The facility meets the requirements of both the US and European regulatory authorities for the production of biotherapeutics and will enable Lonza to supply customers with products for all clinical phases as well as for commercial requirements, the company said.
In addition, Lonza recently filed an application for the modification of its establishment license, issued by the Swiss regulatory authority Swissmedic. The modification will enable the manufacture of recombinant vaccines by fermentation.
By expanding its biotech capabilities, Lonza said it is responding to increasing customer demands for microbially-produced biopharmaceuticals. The investment in the facility has cost over SF 30 million (€20m).
