Author Archives: Andrew Kelly

Application of QbD Concepts to a Final Sterile Filtration Step

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The International Committee for Harmonization (ICH) defines quality by design (QbD) as “a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.†When implementing a QbD approach, biomanufacturers need to identify a product’s critical quality attributes (CQAs) from which a reliable manufacturing process capable of delivering the CQAs can then be developed. This is achieved by performing a risk assessment on each attribute…

November 17, 2015

Successful Filtration Scale-Up for an Automated, Single-Use, Final Bulk-Fill System

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This application note describes a case study of the correct sizing for a filter involved in an automated final bulk-fill system for a biopharmaceutical product. It demonstrates how customer batch-processing requirements can be attained with a robust experimental design. Scale-Up Methodology Figure 1 shows a process for successful scale-up. Once the desired process has been defined, filter performance can be determined by either constant flow or constant pressure testing on disc formats. The data can be scaled-up easily to determine…

August 15, 2014

PROPOR MR

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      Microbial contamination of cell cultures is a major process risk that leads to lost production batches with considerable economic impact for a biopharmaceutical manufacturer. Incidences of penetration of typical 0.2-µm sterilizing-grade membranes by mycoplasma species have led to higher-retention 0.1-µm–rated filters becoming commonplace for filtering mammalian cell culture media.   Increasing Retention without Slowing Down Processing   There are a number of 0.1-µm–rated filters available, and although many are effective at removing mycoplasma contamination, the tighter filtration…

August 1, 2012