Chemistry, manufacturing, and control postapproval changes are an intrinsic part of the life
cycle of pharmaceutical products. In this paper, the authors examined the potential impact of …

Purpose Throughout the life cycle of a biotechnological drug product, changes and
improvements of manufacturing processes are common. It is required by the regulatory …

The comparability assessment of a biological product after implementing a manufacturing
process change should involve a risk-based approach. Process changes may occur at any …

Biopharmaceuticals have traditionally been defined by their manufacturing processes. Over
the course of a product's life cycle a biopharmaceutical manufacturer often faces the …

To ensure the quality of drug products and patient safety, pharmaceutical companies need
to manage and justify changes in chemistry, manufacturing, and controls (CMC). Analytical …

On February 3–4, 2009, a DIA Workshop was held to review and discuss comparability
challenges and issues for biotechnology-derived pharmaceuticals. The workshop was held …

The objective of this document is to provide principles for assessing the comparability of
biotechnological/biological products before and after changes are made in the …

Biological products are complex mixtures of molecular species. Their individual entities are
difficult to characterize. During development and post-approval, improvements are made in …

The Food and Drug Administration (FDA) is announcing the availability of a guidance
entitled" Q5E Comparability of Biotechnological/Biological Products Subject to Changes in …

Manufacturers need the freedom to make changes for improving their biopharmaceutical
processes, not only during clinical development but also for continuous process …