Dieter Schmalzing, Author at BioProcess InternationalBioProcess International

Myths, Risks, and Best Practices: Production Cell Line Development and Control of Product Consistency During Cell Cultivation

by Barry Cherney, Dieter Schmalzing, Steffen Gross, Juhong Liu and Christopher Frye

Health authorities are requesting substantial details from sponsors regarding practices used to generate production cell lines for recombinant DNA–(rDNA) derived biopharmaceuticals. Authorities also are asking for information about the clonality of master cell banks (MCBs) and control strategies to minimize genetic heterogeneity. Such requests are prompted by recent reports indicating “nonclonality” for certain production cell lines. To address these and related issues, the CASSS CMC Strategy Forum on “Production Cell Line Development and Control of Product Consistency During Cell Cultivation:…

eBook: Production Cell-Line Development and Control of Product Consistency During Cultivation — Myths, Risks, and Best Practices

by Barry Cherney, Dieter Schmalzing, Steffen Gross, Juhong Liu and Christopher Frye

Health authorities are requesting substantial details from sponsors regarding practices used to generate production cell lines for recombinant DNA–(rDNA) derived biopharmaceuticals. Authorities also are asking for information about the clonality of master cell banks (MCBs) and control strategies to minimize genetic heterogeneity. Such requests are prompted by recent reports indicating “nonclonality” for certain production cell lines. To address these and related issues, the CASSS CMC Strategy Forum on “Production Cell Line Development and Control of Product Consistency During Cell Cultivation:…

Science, Risks, and Regulations: Current Perspectives on Host Cell Protein Analysis and Control

by Zahra Shahrokh, Dieter Schmalzing, Rashmi Rawat, Victoria Sluzky, Kowid Ho, Jorg Engelbergs, John Bishop, Erika Friedl, Bruce Meiklejohn and Nadine Ritter

State-of-the-art analytics guide process development by providing companies with thorough understanding, effective removal, suitable control, and comparability assessment after process changes of host cell proteins (HCPs) in recombinant biotechnology products. An array of analytical techniques and approaches can be used to establish control strategies for host cell proteins. Techniques used for HCP characterization and comparability include two-dimensional (2D) gel electrophoresis with a range of stains, 2D immunoblotting, 2D high-performance liquid chromatography (HPLC), 2D difference gel electrophoresis (DIGE), and increasingly mass…

CMC Strategy Forum Special Focus Series: Part 2 Product-Related Impurities, An Overview

by Cheryl Scott, Siddharth J. Advant, Yves Aubin, John Bishop, Barry Cherney, Anthony Mire-Sluis, JR Dobbins, Julia Edwards, Sarah Kennett, Joseph Kutza, PhD, Timothy Schofield, Kimberly May, Stefanie Pluschkell, Nadine Ritter, Reb Russell, Oscar Salas-Solano, PhD, Dieter Schmalzing, Zahra Shahrokh, Jeffrey Staecker and Andrew Weiskopf

Introduction by Cheryl Scott The CMC Strategy Forums focus on relevant chemistry, manufacturing, and controls (CMC) issues throughout the life cycle of a therapeutic and thereby foster collaborative technical and regulatory interaction. Forum chairs share information with regulatory agencies to help them merge good scientific and regulatory practices. Outcomes of forum meetings are published in BioProcess International and on the CASSS website. This process is meant to help ensure that biopharmaceutical products manufactured with advancing technologies in a regulated environment…

Bridging Analytical Methods for Release and Stability Testing: Technical, Quality and Regulatory Considerations

by Nadine Ritter, Reb Russell, Timothy Schofield, Laurie Graham, Paul Dillon, Frank Maggio, Lokesh Bhattacharyya, Dieter Schmalzing, Wei-Meng Zhou, Kenneth Miller and Harry Yang

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.…

Reference Standards for Therapeutic Proteins: Current Regulatory and Scientific Best Practices

by Anthony Mire- Sluis, Nadine Ritter, Barry Cherney, Dieter Schmalzing and Markus Blumel

Sponsors developing and manufacturing protein therapeutic products use a variety of analytical tests (e.g., cell-based potency and chromatographic assays) to assess quality attributes of their active ingredients and drug products. Those tests are used to assess product quality in a number of activities, including characterization, comparability, lot release, and confirmation product quality and stability. Reference standards play a critical role in calibrating and confirming the suitability of such tests and in helping analysts to draw scientifically sound conclusions from data…

Covering the whole development process for the global biotechnology industry