nadine ritter - Academia.edu (original) (raw)

Papers by nadine ritter

S ponsors developing and manufacturing protein therapeutic products use a number of analytical te... more S ponsors developing and manufacturing protein therapeutic products use a number of analytical tests (e.g., cell-based potency and chromatographic assays) to assess quality attributes of their active ingredients and drug products. Tests are conducted for a number of purposes, including characterization, comparability, lot release, and confirmation of stability. This two-part article includes the findings of the California Separation Science Society (CASSS) Chemistry, Manufacturing, and Controls (CMC) Strategy Forum titled “Reference Standards for Therapeutic Proteins: Current Regulatory and Scientific Best Practices and Remaining Needs,” held in Gaithersburg, MD, on 15–16 July 2013. The discussion also is based on findings of previous CASSS reference standard meetings, two workshops held during the WCBP conferences in 2012 and 2013, and the conference “Reference Standards for Therapeutic Proteins: Their Relevance, Development, Qualification and Replacement” (1–5). The latter was coo...

Determining protein concentration: Part 1: Methodology

Biopharm International, Apr 1, 2002

Determining protein concentration is one of the most Important analytical methods used in the dis... more Determining protein concentration is one of the most Important analytical methods used in the discovery, development, and manufacturing of protein products. Part 1 discusses a number of methods for analyzing samples ranging from complex mixtures to highly purified proteins.

Analytical Test Methods for Biological and Biotechnological Products

Guidelines, Current Practices, and Industrial Case Studies, 2005

8.1 Analytical Characterization of Biomolecular Products 278 8.2 Physiochemical Profile of Biotec... more 8.1 Analytical Characterization of Biomolecular Products 278 8.2 Physiochemical Profile of Biotechnological/ Biological Products 280 8.3 Analytical Methods Used in Production Operations 282 8.3.1 Raw Material Methods 283 8.3.2 In-Process Methods 284 8.3.3 Drug Substance and Drug Product Methods 286 8.4 Methods Used for Product Characterization, Release, and Stability Testing 286 8.4.1 QC Release Tests — Thumbs Up or Thumbs Down? 289

Analytical Test Methods for Well-Characterized Biological and Biotechnological Products

Biotechnology and Bioprocessing, 2012

To monitor the control and consistency of products derived from biological systems, a broad array... more To monitor the control and consistency of products derived from biological systems, a broad array of analytical methods are used for biopharmaceutical release and stability testing. These methods include both classical and state-of-the-art technologies as well as new technologies as they emerge over time.During the life cycle of a product, several reasons can arise for making changes in existing analytical methods: e.g., improved sensitivity, specificity, or accuracy; increased operational robustness; streamlined workflows; shortened testing times; and lowered cost of testing. Note that replacing an existing method is not the same as adding a new method to a release or stability test panel. An added method has no previous data sets, so there is nothing to be “bridged.” But an existing method is tied to the historical data sets it produced (e.g., for Certificate of Analysis tests) and may still be producing (e.g., for ongoing stability protocols). Thus, significant changes in the met...

S ponsors developing and manufacturing protein therapeutic products use a number of analytical te... more S ponsors developing and manufacturing protein therapeutic products use a number of analytical tests (e.g., cell-based potency and chromatographic assays) to assess quality attributes of their active ingredients and drug products. Tests are conducted for a number of purposes, including characterization, comparability, lot release, and confirmation of stability. This two-part article includes the findings of the California Separation Science Society (CASSS) Chemistry, Manufacturing, and Controls (CMC) Strategy Forum titled “Reference Standards for Therapeutic Proteins: Current Regulatory and Scientific Best Practices and Remaining Needs,” held in Gaithersburg, MD, on 15–16 July 2013. The discussion also is based on findings of previous CASSS reference standard meetings, two workshops held during the WCBP conferences in 2012 and 2013, and the conference “Reference Standards for Therapeutic Proteins: Their Relevance, Development, Qualification and Replacement” (1–5). The latter was coo...

Determining protein concentration: Part 1: Methodology

Biopharm International, Apr 1, 2002

Determining protein concentration is one of the most Important analytical methods used in the dis... more Determining protein concentration is one of the most Important analytical methods used in the discovery, development, and manufacturing of protein products. Part 1 discusses a number of methods for analyzing samples ranging from complex mixtures to highly purified proteins.

Analytical Test Methods for Biological and Biotechnological Products

Guidelines, Current Practices, and Industrial Case Studies, 2005

8.1 Analytical Characterization of Biomolecular Products 278 8.2 Physiochemical Profile of Biotec... more 8.1 Analytical Characterization of Biomolecular Products 278 8.2 Physiochemical Profile of Biotechnological/ Biological Products 280 8.3 Analytical Methods Used in Production Operations 282 8.3.1 Raw Material Methods 283 8.3.2 In-Process Methods 284 8.3.3 Drug Substance and Drug Product Methods 286 8.4 Methods Used for Product Characterization, Release, and Stability Testing 286 8.4.1 QC Release Tests — Thumbs Up or Thumbs Down? 289

Analytical Test Methods for Well-Characterized Biological and Biotechnological Products

Biotechnology and Bioprocessing, 2012

To monitor the control and consistency of products derived from biological systems, a broad array... more To monitor the control and consistency of products derived from biological systems, a broad array of analytical methods are used for biopharmaceutical release and stability testing. These methods include both classical and state-of-the-art technologies as well as new technologies as they emerge over time.During the life cycle of a product, several reasons can arise for making changes in existing analytical methods: e.g., improved sensitivity, specificity, or accuracy; increased operational robustness; streamlined workflows; shortened testing times; and lowered cost of testing. Note that replacing an existing method is not the same as adding a new method to a release or stability test panel. An added method has no previous data sets, so there is nothing to be “bridged.” But an existing method is tied to the historical data sets it produced (e.g., for Certificate of Analysis tests) and may still be producing (e.g., for ongoing stability protocols). Thus, significant changes in the met...