CMC Forums

Featured on CMC Forums

BioProcess Insider Interview: Min Park, Chief Business Officer, Aton Biotech
Sponsored Content
BioProcess Insider Interview: Min Park, Chief Business Officer, Aton BiotechBioProcess 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 BiologicsCell Lines Are the Foundation: A Methodical Approach to Derisking Outsourced Development and Improving Manufacturability of Novel Biologics
byJason Condon
Apr 20, 2023
Risk-Based Biologics: CMC Flexibilities in the EU Regulatory System
CMC Forums
Risk-Based Biologics: CMC Flexibilities in the EU Regulatory SystemRisk-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 BispecificsDNA 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
CMC Forums
20 Years of Chemistry, Manufacturing, and Controls Strategy. A Conversation About the CASSS CMC Forum Series20 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 Forums
CMC Strategies for Expedited Program Development — Regulatory Perspectives: Session 1 of a CMC Strategy ForumCMC Strategies for Expedited Program Development — Regulatory Perspectives: Session 1 of a CMC Strategy Forum
byNatalya Ananyeva, David Robbins
May 20, 2022

More from CMC Forums

eBook: Creating CMC Strategies for Pandemics and Beyond — Perspectives on the Impact of the COVID-19 Pandemic
CMC Forums
eBook: Creating CMC Strategies for Pandemics and Beyond — Perspectives on the Impact of the COVID-19 Pandemic
eBook: Creating CMC Strategies for Pandemics and Beyond — Perspectives on the Impact of the COVID-19 Pandemic
Nov 30, 2021
+4
byKim Wolfram, Nina S. Cauchonand 4 more
Implementation of Established Conditions: Learnings from a “Sharing Science Solutions” Workshop
CMC Forums
Implementation of Established Conditions: Learnings from a “Sharing Science Solutions” Workshop
Implementation of Established Conditions: Learnings from a “Sharing Science Solutions” Workshop
Oct 28, 2021
+4
bySarah Kennett, Kristopher Barnthouseand 4 more
Emerging Strategies for Drug-Product Comparability and Process Validation: Part 2 — Validation, Legacy Products, and Lifecycle Management
CMC Forums
Emerging Strategies for Drug-Product Comparability and Process Validation: Part 2 — Validation, Legacy Products, and Lifecycle Management
Emerging Strategies for Drug-Product Comparability and Process Validation: Part 2 — Validation, Legacy Products, and Lifecycle Management
Apr 16, 2021
+7
byZahra Shahrokh, Andrew Weiskopfand 7 more
Automation of Potency Assays: A Strategic Journey
CMC Forums
Automation of Potency Assays: A Strategic Journey
Automation of Potency Assays: A Strategic Journey
Mar 9, 2021
+1
byMaribel Rios, Cheryl Scottand 1 more
Emerging Strategies for Drug Product Comparability and Process Validation: Part 1 — Analytical Tools and Drug Product Comparability
CMC Forums
Emerging Strategies for Drug Product Comparability and Process Validation: Part 1 — Analytical Tools and Drug Product Comparability
Emerging Strategies for Drug Product Comparability and Process Validation: Part 1 — Analytical Tools and Drug Product Comparability
Mar 9, 2021
+7
byZahra Shahrokh, Andrew Weiskopfand 7 more
Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies, Part 2: Process Modeling and Analytics
CMC Forums
Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies, Part 2: Process Modeling and Analytics
Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies, Part 2: Process Modeling and Analytics
Dec 17, 2020
+8
byAnthony Mire-Sluis, Sarah Kennettand 8 more
Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies, Part 1: Upstream and Downstream Strategies
CMC Forums
Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies, Part 1: Upstream and Downstream Strategies
Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies, Part 1: Upstream and Downstream Strategies
Oct 29, 2020
+7
byAnthony Mire-Sluis, Sarah Kennettand 7 more
Development of Patient-Focused Commercial Specifications: Understanding Clinical Relevance and Criticality of Quality Attributes
CMC Forums
Development of Patient-Focused Commercial Specifications: Understanding Clinical Relevance and Criticality of Quality Attributes
Development of Patient-Focused Commercial Specifications: Understanding Clinical Relevance and Criticality of Quality Attributes
Sep 22, 2020
+9
byAnthony Mire-Sluis, Jason Starkeyand 9 more
Trends in Chemistry, Manufacturing, and Controls: Next-Generation Technologies and Product Modalities
CMC Forums
Trends in Chemistry, Manufacturing, and Controls: Next-Generation Technologies and Product Modalities
Trends in Chemistry, Manufacturing, and Controls: Next-Generation Technologies and Product Modalities
Sep 25, 2018
byCheryl Scott
Myths, Risks, and Best Practices: Production Cell Line Development and Control of Product Consistency During Cell Cultivation
Cell Line Development
Myths, Risks, and Best Practices: Production Cell Line Development and Control of Product Consistency During Cell Cultivation
Myths, Risks, and Best Practices: Production Cell Line Development and Control of Product Consistency During Cell Cultivation
Sep 19, 2018
+3
byBarry Cherney, Dieter Schmalzingand 3 more
eBook: Quality By Design for Monoclonal Antibodies — Establishing the Foundations for Process Development, Design Space, and Process Control
QA/QC
eBook: Quality By Design for Monoclonal Antibodies — Establishing the Foundations for Process Development, Design Space, and Process Control Strategies
eBook: Quality By Design for Monoclonal Antibodies — Establishing the Foundations for Process Development, Design Space, and Process Control Strategies
Jun 22, 2018
+1
byBrendan Cooney, Susan Dana Jonesand 1 more
Methods on the Move: Addressing Method Transfer Challenges for the Biopharmaceutical Industry
CMC Forums
Methods on the Move: Addressing Method Transfer Challenges for the Biopharmaceutical Industry
Methods on the Move: Addressing Method Transfer Challenges for the Biopharmaceutical Industry
Jun 20, 2018
+1
byMary Beth Pelletier, Jeffrey Staeckerand 1 more
eBook: Production Cell-Line Development and Control of Product Consistency During Cultivation — Myths, Risks, and Best Practices
Cell Line Development
eBook: Production Cell-Line Development and Control of Product Consistency During Cultivation — Myths, Risks, and Best Practices
eBook: Production Cell-Line Development and Control of Product Consistency During Cultivation — Myths, Risks, and Best Practices
Apr 30, 2018
+3
byBarry Cherney, Dieter Schmalzingand 3 more
Change Happens: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (CMC Forum)
CMC Forums
Change Happens: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (CMC Forum)
Change Happens: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (CMC Forum)
Sep 19, 2017
+5
byJoseph Kutza, PhD, Julia Edwardsand 5 more
Strategies for Successful Sample Transfer
QA/QC
Strategies for Successful Sample Transfer
Strategies for Successful Sample Transfer
Apr 17, 2017
+1
byMaribel Rios, S. Anne Montgomeryand 1 more
CMC Strategy Forum on Combination Products for Biopharmaceuticals: Emerging Trends in Development, GMPs, and Regulatory Expectations
CMC Forums
CMC Strategy Forum on Combination Products for Biopharmaceuticals: Emerging Trends in Development, GMPs, and Regulatory Expectations
CMC Strategy Forum on Combination Products for Biopharmaceuticals: Emerging Trends in Development, GMPs, and Regulatory Expectations
Mar 20, 2017
+6
bySiddharth J. Advant, PhD, Jee Chungand 6 more
CMC Forum: Evolution of Biopharmaceutical Control Strategy Through Continued Process Verification
CMC Forums
CMC Forum: Evolution of Biopharmaceutical Control Strategy Through Continued Process Verification
CMC Forum: Evolution of Biopharmaceutical Control Strategy Through Continued Process Verification
Jan 19, 2017
+5
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
CMC Forums
Special Report on Process- and Product-Related Impurities (A CMC Strategy Forum Special Focus Series): Extractables, Leachables, Particles, and Aggregates
Special Report on Process- and Product-Related Impurities (A CMC Strategy Forum Special Focus Series): Extractables, Leachables, Particles, and Aggregates
Nov 17, 2016
+3
byAnthony Mire-Sluis, Stacey Maand 3 more
Science, Risks, and Regulations: Current Perspectives on Host Cell Protein Analysis and Control
CMC Forums
Science, Risks, and Regulations: Current Perspectives on Host Cell Protein Analysis and Control
Science, Risks, and Regulations: Current Perspectives on Host Cell Protein Analysis and Control
Sep 15, 2016
+8
byZahra Shahrokh, Dieter Schmalzingand 8 more
CMC Strategy Forum Special Focus Series: Part 2 Product-Related Impurities, An Overview
CMC Forums
CMC Strategy Forum Special Focus Series: Part 2 Product-Related Impurities, An Overview
CMC Strategy Forum Special Focus Series: Part 2 Product-Related Impurities, An Overview
Apr 12, 2016
+18
byCheryl Scott, Siddharth J. Advant, PhDand 18 more
Defining Your Product Profile and Maintaining Control Over It | A Look Back with Emily Shacter
Bioanalytical Methods
Defining Your Product Profile and Maintaining Control Over It | A Look Back with Emily Shacter
Defining Your Product Profile and Maintaining Control Over It | A Look Back with Emily Shacter
Feb 11, 2016
byLeah Rosin
Process- and Product-Relate Impurities: Part 1 – Process-Related Impurities An Overview
Process Development
Process- and Product-Relate Impurities: Part 1 – Process-Related Impurities An Overview
Process- and Product-Relate Impurities: Part 1 – Process-Related Impurities An Overview
Feb 4, 2016
byHeather Simmerman, Raymond P. Donnelly
Special Report on Assays, Test Methods, and Comparability: The CMC Strategy Forum Series, Part 4, Introduction
CMC Forums
Special Report on Assays, Test Methods, and Comparability: The CMC Strategy Forum Series, Part 4, Introduction
Special Report on Assays, Test Methods, and Comparability: The CMC Strategy Forum Series, Part 4, Introduction
Nov 17, 2015
byCheryl Scott
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, The Role of Higher-Order Structure in Defining logo in a gray background | Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, The Role of Higher-Order Structure in Defining
QA/QC
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, The Role of Higher-Order Structure in Defining Biopharmaceutical Quality
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, The Role of Higher-Order Structure in Defining Biopharmaceutical Quality
Nov 17, 2015
+3
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 logo in a gray background | Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, Demonstrating Comparability for Well-Characterized
QA/QC
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, Demonstrating Comparability for Well-Characterized Biotechnology Products: Early Phase, Late Phase, and Postapproval
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, Demonstrating Comparability for Well-Characterized Biotechnology Products: Early Phase, Late Phase, and Postapproval
Nov 17, 2015
byJohn Towns, Keith Webber
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, The Roles of Bioactivity Assays in Lot Release and logo in a gray background | Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, The Roles of Bioactivity Assays in Lot Release and
Fill/Finish
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, The Roles of Bioactivity Assays in Lot Release and Stability Testing
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, The Roles of Bioactivity Assays in Lot Release and Stability Testing
Nov 17, 2015
+5
byNoel Rieder, Helene Gazzano-Santoroand 5 more
Analysis and Characterization: The CMC Strategy Forum Series, Part 3 — Introduction
CMC Forums
Analysis and Characterization: The CMC Strategy Forum Series, Part 3 — Introduction
Analysis and Characterization: The CMC Strategy Forum Series, Part 3 — Introduction
Sep 23, 2015
byCheryl Scott
Uniting Small-Molecule and Biologic Drug Perspectives: Analytical Characterization and Regulatory Considerations for Antibody–Drug Conjugates
Emerging Therapeutics
Uniting Small-Molecule and Biologic Drug Perspectives: Analytical Characterization and Regulatory Considerations for Antibody–Drug Conjugates
Uniting Small-Molecule and Biologic Drug Perspectives: Analytical Characterization and Regulatory Considerations for Antibody–Drug Conjugates
Sep 23, 2015
+4
byLorna McLeod, Jon Harrisand 4 more
Glycosylation of Therapeutic Proteins: Current Understanding of Structure–Function Relationships logo in a gray background | Glycosylation of Therapeutic Proteins: Current Understanding of Structure–Function Relationships
Product Characterization
Glycosylation of Therapeutic Proteins: Current Understanding of Structure–Function Relationships
Glycosylation of Therapeutic Proteins: Current Understanding of Structure–Function Relationships
Sep 23, 2015
+4
byJoseph Siemiatkoski, Stacey Maand 4 more
Analysis and Structure Characterization of Monoclonal Antibodies logo in a gray background | Analysis and Structure Characterization of Monoclonal Antibodies
Product Characterization
Analysis and Structure Characterization of Monoclonal Antibodies
Analysis and Structure Characterization of Monoclonal Antibodies
Sep 23, 2015
+4
byMark Schenerman, Brooks Sundayand 4 more

Webinars

Ask the Expert webcasts
ATE Webcasts
Register Now: Light Boxes and Beyond: Maximizing Confidence in Clone Selection Using the Beacon Optofluidic System
Register Now: Light Boxes and Beyond: Maximizing Confidence in Clone Selection Using the Beacon Optofluidic System
Insider News
See all
Mar 18 - Mar 21, 2025
SLASH TIME FROM BENCH TO BEDSIDE: Cutting-edge biomanufacturing for mAbs, vaccines, and advanced therapies. Bright ideas, bold science, and big innovations—delivering efficiency, precision, and quality through every phase of bioprocessing.
Learn More

Innovative Technology

Thermo Fisher Scientific peptones white paper
Sponsored Content
The Value of Peptones for Enhancing Biopharmaceutical Productivity
The Value of Peptones for Enhancing Biopharmaceutical Productivity

Jan 27, 2025

Nagase Trehalose SG
Sponsored Content
Innovative Impurity Reduction in Harvesting Process With TREHALOSE SG
Innovative Impurity Reduction in Harvesting Process With TREHALOSE SG

Jan 9, 2025

Bruker Tornado Spectroscopy
Sponsored Content
Monitoring and Controlling Upstream Bioprocesses with Raman Spectroscopy
Monitoring and Controlling Upstream Bioprocesses with Raman Spectroscopy

Dec 1, 2024

Subscribe to receive our monthly print or digital publication
Join our 70,000+ readers. And yes, it's completely free.
Subscribe