Scaling up biological processes from laboratory bench to process scale is complex and requires considering a number of factors to ensure process robustness. Due to variability among raw materials and processes, most process developers use generous safety factors to ensure that their systems are not undersized. Although that method can be reduce process risk, it is inefficient. To improve process efficiency and reduce risk, we conducted a study to identify and quantify key factors that contribute to variability…
Author Archives: Laurelle Sciola
Demonstrating Millipore Express® SHR Filters Mycoplasma Clearance Capability
Mycoplasma is known to be a common source of bioprocessing contamination and one of the most difficult contaminants to detect. The effect of a mycoplasma contamination can be catastrophic, resulting in loss of a batch, loss of future production, down-time for investigation and corrective actions, and the potential risk of therapeutic supply shortages to immunocompromised patients. To demonstrate Millipore Express SHR filters’ mycoplasma clearance capability over extended filtration times, two separate Acholeplasma laidlawii retention studies…