REGULATORY
In Biosimilar Analytical Development, Is A CQA Ever Not Critical?
The word "critical" implies a binary signal. The attribute is either existentially important or it's not.
Training AI Models
In this segment from the Bioprocess Online Live, “A Realistic Look At AI/ML In Biomanufacturing,” panelists talk about what makes a good AI model and highlight considerations for training these models.
Facing NASH Therapeutic Skepticism With 89bio's Rohan Palekar
The non-alcoholic steatohepatitis (NASH) therapeutics market has proven to be an 11/10 on the difficulty scale. Despite billions of big biopharma dollars invested in therapeutic development, and a few close calls, no therapeutics has yet reached the finish line.
A CDMO Perspective: Bioprocess Automation And Data Management
Watch this video to understand data management and process automation challenges across single-use bioprocessing applications from a CDMO leader, Paul Jorjorian, VP and GM of Pharma Services at Thermo Fisher Scientific.
Streamline Production With A Final Filling Single-Use Set
Streamline your production with a Final Filling Single-Use Set that installs in under 10 minutes to eliminate cleaning and sterilization while ensuring Annex 1 compliance and full customization.
MES Apps Built For Speed And Seamless Integration
Digitize bioprocess workflows to achieve consistent, paper-free execution that deploys up to 66% quicker than traditional MES with a cloud-based, no-code platform built for single-use bioprocessing.
Process Intensification: Challenges, Trends, And Industry Takeaways
Process intensification is here and transforming industries now. Discover how experts and early adopters are tackling challenges and unlocking new efficiencies through sustainable technologies.
Faciliflex Cleanroom Module For Therapeutic Drug Manufacturing
The Faciliflex Module is a transformational new concept in designing cleanrooms for the production of lifesaving therapeutics.
Strategies To Reduce Regulatory Risks In Gene Therapy
Learn how to mitigate regulatory risk for your gene therapy process.
Executive Roundtable: Cell Therapy Predictions For 2025 And Beyond
In this executive roundtable discussion, Bioprocess Online editor Tyler Menichiello is joined by CEO, co-founder, and president of Ossium Health, Kevin Caldwell, CSO of FibroBiologics, Hamid Khoja, Ph.D., and president and acting CEO of Triumvira Immunologics, Ro...
How Is U.S. Policy Reshaping Global Biomanufacturing Operations?
In this opening segment from the Bioprocess Online Live event, “Protecting Bioprocessing Operations and Supply Chains In A Turbulent Economy,” panelists Adam Golin, Jon Lindbloom, and James Sapirstein speak candidly about how U.S. tariffs are affecting the glo...
Fill And Finish: Your Final Step Is Our First Priority
Fill and finish demands precision, compliance, and adaptability. Learn how flexible solutions and expert support can help you overcome complexity, reduce risk, and ensure quality in this final step.
Dr. Peter Marks Talks a Standardized Playbook for Gene Therapy Manufacturing
In this segment, Dr. Peter Marks shares developments in CMC for advanced therapies in the near future.
Regulatory And Biosafety Testing Expertise
Advancing biologics requires confidence in safety, quality, and compliance. Learn how integrated analytical and biosafety testing, backed by decades of expertise, helps reduce risk.
MilliporeSigma Bio-Expo Live February 2025: Upstream Bioprocessing
Review the benefits of implementing a closed and sterile sampling system, such as NovaSeptum®, to improve sampling procedures and meet regulatory expectations.
Engineering Bacterial Vector-Based Immunotherapies With OS Therapies' Paul Romness and Robert Petit, Ph.D.
In this episode of “Better Biopharma,” host Tyler Menichiello is joined by OS Therapies’ CEO, Paul Romness, and chief medical and scientific officer, Robert Petit, Ph.D. The three discuss the development and manufacturing of the com...
When And How To Implement Process Intensification
Explore when to intensify your processes, what challenges to expect, and how to prepare for a successful transition with expert insights to help guide your strategy and ensure smoother implementation.
A Straightforward Path Toward Regulatory Compliance & Data Integrity With Your Microbial Testing Systems
In this webinar, we will share a variety of strategies for implementing and validating microbial identification systems in the cGMP environment, possible difficulties along the way, and a comprehensive solution that addresses these challenges.
US GMP (21 CFR 820) Manufactured Oligos For Preclinical Research
Learn why Custom cGMP Oligos should be considered to ensure oligo products meet the strict standards of MDx, LDTs, and preclinical research.
Flexibility First: A Fill And Finish Collaboration Story
Learn how Annex 1 is influencing isolator strategies, why standardization is key to efficiency, and how collaboration can simplify integration for reliable drug product filling.
Master The 2-Point Calibration Process To Maintain Data Integrity
Ensure accurate sensor readings with an innovative software by mastering the 2-point calibration process. Learn more about how and why regular calibration supports data integrity and compliance.
Standards' Role In Biosimilarity Assessment
Standards are useful tools for specific purposes, but they represent a one-point target. They do not capture the full range of variability found in reference products on the market.
Select Your Best Downstream Process Intensification Strategy
Intensified and connected processing can cut costs and eliminate bottlenecks in mAb manufacturing. Discover how to identify the most efficient chromatography methods and future-proof your operations.
Simplifying Bioprocess Data Collection
Centralized bioprocess data collection and aggregation lowers the risk of data loss during any manual retrieval process. Discover a solution that helps you meet data storage and reporting requirements.
Comparing Biosimilars To Drifting Reference Product Data
First-time biosimilar developers might be surprised to find significant lot-to-lot quality attribute shifts in their reference product.
How To Avoid A Biosimilar Comparative Efficacy Study, If Possible
Few companies, if any, would ever eagerly volunteer to perform a comparative efficacy study (CES) for their biosimilar candidate. The FDA has been clear all along that compelling a CES remains a tool in its toolbox if the agency believes it's necessary. So what might ...
An Efficient And Reliable Way To Digitalize Your Sterility And QC Testing Data
Watch to learn about the M-Trace™ Electronic Test Record Software, your digital QC companion for trusted and efficient data recording that automizes and digitalizes your sterility and QC testing data.
Levers For Streamlining And Optimizing The Biosimilar Process
New and more advanced production methods mean biosimilar developers can produce their own versions of commercial drugs with greater efficiency. Levers like cell line engineering and bioreactor controls make it easier to increase productivity. Biologics Consulting Group Pr...
Developing Antibodies To Block Neuroinflammation With MindImmune's Stevin Zorn, Ph.D.
In this episode of "Better Biopharma," host Tyler Menichiello is joined by MindImmune's president and CEO, Stevin Zorn, Ph.D. They discuss the development of the company's lead candidate, MITI-101, a monoclonal antibody designed to prevent peripheral imm...
The ICH Q5A Revision, Its New Scope And Guidance
Learn about the ICH Q5A revision addressing viral safety of biotechnology products derived from cell lines of human or animal origin that was recently published for public comment.