Author Archives: Parrish Galliher
Global Evolution of Biomanufacturing
Biomanufacturing of human therapeutics is beginning a global transformation. New technologies, improved processes, the emergence of biosimilars, and growing worldwide demand for vaccines and biologic drugs to serve local populations are driving this transformation. Over the next few years, diverse new markets will open, creating opportunities for a range of companies seeking to enter the field while putting pressure on established biomanufacturers to reassess their operating models. Many traditional barriers-to-entry in biomanufacturing are diminishing. Yet other challenges — including access…
Scaling Up a CHO-Produced Hormone–Protein Fusion Product
Many biotechnology companies recognize the powerful benefits of increasing product titer early in product development as a strategy to minimize manufacturing costs, scale, and the duration necessary to produce clinical supplies and achieve product commercialization. Additional benefits include minimizing or completely avoiding significant regulatory delays to market that can be caused by major process technology changes (such as cell line and product quality changes). Recently, another significant benefit has been realized too: Smaller, more productive and efficient 2,000-L…