Category: Manufacturing and Bioprocessing
Purpose: Freeze drying, also known as lyophilization, is a dehydration process aimed to prolong the shelf life of injectable drug products. In an effort to assist sponsors of drug products in submitting high-quality applications, this report presents considerations and recommendations for basic processes involved in manufacturing lyophilized drug products.
Methods: As such, a general discussion on each unit operation such as compounding, filtration, filling, and lyophilization is provided to help sponsors of drug products establish reliable manufacturing processes from a regulatory perspective.
Results: In addition, a list of common deficiencies identified from a total of 226 drug applications including New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) received since 2015 is provided.
Conclusion: The information provided here will be helpful to build quality into a product, insomuch that lack of either justification or scientific rationale backed by data while addressing manufacturing related deficiencies has been found to lead to delay in approval of applications. In light of the information gleaned from this report, it is expected that a desired standard of quality in future submissions can be achieved to ensure the quality, efficacy, and safety of lyophilized drug products. This will, in turn, immensely benefit the pharmaceutical industry as well as the American public health.