This is Part 1 of a two-part article covering important considerations when developing devices for combination products — and why they need to be addressed early in development. In this installment, we'll discuss primary container, device development, device selection, and design control.
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By Matthew Olsen,Sartorius Stedim Biotech
Familiarity and experience with single-use products are leading to a grassroots demand for advancement in the science and technology of single-use bioprocessing. This article discusses four key topics related to single-use bioprocessing that are commonly cited by end users as amenable to future development.
While some are waiting for mandates for traceability, serialization, and aggregation, others are recognizing the inevitability of these strategies. Does your CMO have a dedicated traceability operation in place?
By Andrew Kelly and Graeme Proctor,Parker Bioscience
Is your bioprocess adequately protected against the risks associated with single-use technology (SUT)? Discover the seven key areas of risk in SUT and learn the strategies to protect against each risk.
MilliporeSigma scientists, ranging in specialty from analytical to immuno-focused, give the listener an understanding of how an antibody’s molecular structure, of which there are many measurable properties that can be measured, influences its binding and affects potency of a therapeutic biologic.