Figure 1: Process flows for 10-L and 200-L upstream processes using single-use bioreactors from GE
In their pursuit of developing therapeutics, biopharmaceutical companies face many challenges, including pressure to meet aggressive timelines, reduce risk and cost, and increase speed to market. Addressing these challenges is especially critical for biosimilar manufacturers, who face fierce competition and an expanding footprint in emerging markets (1). The global biosimilars market is growing rapidly and is expected to exceed more than US$6 billion by 2020 (2).
This case study describes how Pfizer is collaborating with GE Healthcare to achieve regulatory approval of biosimilars in China by streamlining process transfer strategies and implementing both single-use technologies and flexible, deployable manufacturing solutions.