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BioProcess Insider Interview: Min Park, Chief Business Officer, Aton Biotech

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BioProcess Insider Interview: Min Park, Chief Business Officer, Aton Biotech BioProcess Insider Interview: Min Park, Chief Business Officer, Aton Biotech

byBPI Contributor

Aug 21, 2023

Cell Lines Are the Foundation: A Methodical Approach to Derisking Outsourced Development and Improving Manufacturability of Novel Biologics

Cell Line Development

Cell Lines Are the Foundation: A Methodical Approach to Derisking Outsourced Development and Improving Manufacturability of Novel Biologics Cell Lines Are the Foundation: A Methodical Approach to Derisking Outsourced Development and Improving Manufacturability of Novel Biologics

Apr 20, 2023

Risk-Based Biologics: CMC Flexibilities in the EU Regulatory System

Risk-Based Biologics: CMC Flexibilities in the EU Regulatory System Risk-Based Biologics: CMC Flexibilities in the EU Regulatory System

byDavid W. Murray

Mar 21, 2023

DNA to IND in 13 Months: A CMC Strategy for Bispecifics

Sponsored Content

DNA to IND in 13 Months: A CMC Strategy for Bispecifics DNA to IND in 13 Months: A CMC Strategy for Bispecifics

byAndrew Brown, PhD

Nov 16, 2022

20 Years of Chemistry, Manufacturing, and Controls Strategy. A Conversation About the CASSS CMC Forum Series

20 Years of Chemistry, Manufacturing, and Controls Strategy. A Conversation About the CASSS CMC Forum Series 20 Years of Chemistry, Manufacturing, and Controls Strategy. A Conversation About the CASSS CMC Forum Series

byCheryl Scott, Nadine M. Ritterand 1 more

Aug 19, 2022

CMC Strategies for Expedited Program Development — Regulatory Perspectives: Session 1 of a CMC Strategy Forum

CMC Strategies for Expedited Program Development — Regulatory Perspectives: Session 1 of a CMC Strategy Forum CMC Strategies for Expedited Program Development — Regulatory Perspectives: Session 1 of a CMC Strategy Forum

byNatalya Ananyeva, David Robbins

May 20, 2022

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eBook: Creating CMC Strategies for Pandemics and Beyond — Perspectives on the Impact of the COVID-19 Pandemic

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Implementation of Established Conditions: Learnings from a “Sharing Science Solutions” Workshop

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Emerging Strategies for Drug-Product Comparability and Process Validation: Part 2 — Validation, Legacy Products, and Lifecycle Management

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Emerging Strategies for Drug Product Comparability and Process Validation: Part 1 — Analytical Tools and Drug Product Comparability

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Development of Patient-Focused Commercial Specifications: Understanding Clinical Relevance and Criticality of Quality Attributes

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Trends in Chemistry, Manufacturing, and Controls: Next-Generation Technologies and Product Modalities

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

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byBrendan Cooney, Susan Dana Jonesand 1 more

Methods on the Move: Addressing Method Transfer Challenges for the Biopharmaceutical Industry

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byMaribel Rios, S. Anne Montgomeryand 1 more

CMC Strategy Forum on Combination Products for Biopharmaceuticals: Emerging Trends in Development, GMPs, and Regulatory Expectations

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bySiddharth J. Advant, PhD, Jee Chungand 6 more

CMC Forum: Evolution of Biopharmaceutical Control Strategy Through Continued Process Verification

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byJR Dobbins, Stefanie Pluschkelland 5 more

Special Report on Process- and Product-Related Impurities (A CMC Strategy Forum Special Focus Series): Extractables, Leachables, Particles, and

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byAnthony Mire-Sluis, Stacey Maand 3 more

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byCheryl Scott, Siddharth J. Advant, PhDand 18 more

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byZiping Wei, Emily Shacterand 3 more

Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, Demonstrating Comparability for Well-Characterized

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byJohn Towns, Keith Webber

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byNoel Rieder, Helene Gazzano-Santoroand 5 more

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Uniting Small-Molecule and Biologic Drug Perspectives: Analytical Characterization and Regulatory Considerations for Antibody–Drug Conjugates

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byLorna McLeod, Jon Harrisand 4 more

Glycosylation of Therapeutic Proteins: Current Understanding of Structure–Function Relationships

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byJoseph Siemiatkoski, Stacey Maand 4 more

Analysis and Structure Characterization of Monoclonal Antibodies

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byMark Schenerman, Brooks Sundayand 4 more