Biosimilars are more challenging to manufacture than traditional generic versions of patent drugs, because they are larger and more complex molecules than generics. They cannot be produced using conventional chemical processes, but instead are developed in living cells. These cells are very sensitive to conditions during their synthesis and handling, and even minor changes in the manufacturing process can cause significant changes in efficacy. Purification rooms house the various stages of protein extraction, filtration and chromatography needed to produce a consistent, high-quality active ingredient, while a media preparation laboratory contains the large bioreactor in which cells grow and proliferate.
To ensure consistency of product, these spaces need to be precisely controlled environments, which provided some challenges for design and construction. Contamination is minimized by separating the path between people and materials, and WSP reviewed the design and construction of the water treatment system and clean room procedures. The performance of the heating and ventilation system was also critical – the energy-efficient solution relies on a thermal wheel that recovers heat from ventilated air and transfers it to the incoming fresh air.
The other challenge that WSP had to overcome was one of speed: the Phase One research facility had to be built and operational within a ten-month program. To help meet this target, the building uses a cold-formed steel frame of prefabricated components that required no on-site welding.
The facility is now operational and has begun production of a second biosimilar for the treatment of colon and rectal cancer. An antibody drug for pancreatic cancer – the first of its kind – is also in development.