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…

Although the demographic of orphan therapies is small, making therapies for rare diseases available has a huge impact for the affected patients. Cooperation to expand capacity and expertise during process development and manufacturing for preclinical and clinical phase studies is one way to increase speed to market. This case study shares the work of GE’s Fast Trak Services team to help accelerate development of a process for cGMP production of material for toxicology studies. Frequent communication between the Fast Trak…

Biosimilars represent an innovative solution that can benefit both patients and healthcare systems by reducing the burden of rising treatment costs. To improve the availability, price, and access of medicines, many countries are implementing strategies to establish their own production capacity. To support such development, MAbxience (a Spanish biotechnology company specialized in research, development, and manufacture of biosimilar drugs) is committed to provide the manufacturing of high-quality products and processes that meet regulatory and technical requirements in all countries where…