Validation of the Recombinant Coagulation Factor IX Purification Process for the Removal of Host Cell DNA

Leonard, Mark; Sefton, Louise; Costigan, Ruth; Shi, Lichen; Hubbard, Brian; Bonam, Duane; Kelley, Brian; Foster, Bernard; Charlebois, Timothy S.

doi:10.1021/bk-1998-0698.ch005

Cited by 6 publications

(1 citation statement)

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“…Kelley et al [12] have also used this approach for robustness testing of an ion‐exchange capture step during recombinant Factor IX purification. Leonard et al [13] used a DOE approach to validate DNA clearance in the Factor IX purification process. Despite these studies, use of a DOE approach is far from widespread in the biopharmaceutical industry for the characterization and validation of purification processes.…”

Section: Introductionmentioning

confidence: 99%

Process characterization for metal‐affinity chromatography of an Fc fusion protein: a design‐of‐experiments approach

Shukla

Sorge

Boldman

et al. 2001

Biotech and App Biochem

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The utility of a design-of-experiments approach was investigated for process characterization of a metal-affinity chromatographic purification process for an Fc fusion protein. This approach gave a better understanding of some of the key process variables as well as robustness for this step in the purification process. Single-variable experiments were employed to screen some of the potentially important variables in this step. Ranges for these variables were set based on prior experience in clinical manufacturing with similar processes. Following these experiments, a fractional factorial study was employed to further investigate the most important variables and their interactions. Key operational variables that had an impact on step yield and eluate purity were identified. In addition, the study helped identify a worst-case scenario for the step purity and helped assure that the rest of the process would successfully purify the product. This paper demonstrates the utility of a design-of-experiments approach for the characterization and validation of process chromatography steps in downstream processing. In addition, this study emphasizes the utility of robustness studies early in process development and establishes a strategy for future robustness studies.

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Section: Introductionmentioning

confidence: 99%

Process characterization for metal‐affinity chromatography of an Fc fusion protein: a design‐of‐experiments approach

Shukla

Sorge

Boldman

et al. 2001

Biotech and App Biochem

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Scaledown of Biopharmaceutical Purification Operations

Rathore

Joshi

2013

Encyclopedia of Industrial Biotechnology

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Biotech‐based therapeutics have emerged as the growth engine for the pharmaceutical industry. Successful development and commercialization of biotech processes require the understanding of the relationships between the various attributes of the product and the product's clinical safety and efficacy, as well as, the effect of the different process parameters on the product's attributes. The complexity of the biotech products and the requirement for rigorous experimentation justify working at small scales. This article presents general guidelines and relevant parameters affecting scale‐down of the various unit operations involved in purification of proteins. The key parameters, assessment methods, assessment techniques, and challenges involved in scale‐down are discussed.

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Protein Subunit Vaccine Purification

Yang

D’Amore

2014

Vaccine Development and Manufacturing

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Validation of the Recombinant Coagulation Factor IX Purification Process for the Removal of Host Cell DNA

Cited by 6 publications

References 0 publications

Process characterization for metal‐affinity chromatography of an Fc fusion protein: a design‐of‐experiments approach

Process characterization for metal‐affinity chromatography of an Fc fusion protein: a design‐of‐experiments approach

Scaledown of Biopharmaceutical Purification Operations

Protein Subunit Vaccine Purification

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