REGULATORY
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...
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.
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...
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.
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.
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.
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.
Building A Comprehensive Control Strategy For Biosimilar Analytics
Like many other biologic drugs, building a comprehensive controls strategy for biosimilars starts with defining critical quality attributes (CQAs), said Vince Narbut, a principal consultant at Biologics Consulting Group, during Bioprocess Online Live: Process Control'...
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...
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.
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.
Criticism Of FDA's Limited Proof-Of-Principle Ignores The Full Breadth Of Biosimilar CQA Understanding
Critics say adalimumab and trastuzumab, two of the most well-characterized antibodies on the market and each with their several approved biosimilars, provide a limited basis for proof of principle. During Bioprocess Online Live: Process Control's Increasing Role In Bi...
Level Up With Product Characterization
In the race to bring a new biotherapeutic to market, unexpected obstacles can slow you down or even knock you back a few steps. But with the right information at the right time, and an experienced partner to provide scientific, regulatory, and bioprocessing guidance and s...
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...
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.
Custom GMP-Grade Oligos
Learn why Custom GMP Oligos should be considered to ensure oligo products meet the strict standards of MDx, LDTs, and preclinical research.
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.
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.
Platforming And The Future Of Standardized Manufacturing Chassis
Platforming downstream processes offers efficiency gains, while upstream processes are standardizing on high-intensity perfusion or fed-batch. Robust analytical data allows for modern efficiencies like single-use systems.
Strategies To Reduce Regulatory Risks In Gene Therapy
Learn how to mitigate regulatory risk for your gene therapy process.
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.
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.
Faciliflex Cleanroom Module For Therapeutic Drug Manufacturing
The Faciliflex Module is a transformational new concept in designing cleanrooms for the production of lifesaving therapeutics.
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.
Creating Technical Debt When Experimenting With 3D Printed Parts
Companies need mature validation paradigms to recognize if and when it's time to transition from a prototype 3D printed part to a sustainable version, likely through a vendor-validated part.
The Burden Of Proof Has Shifted To Analytics For Biosimilar Approval
The FDA's recent and stunning declaration that comparative analytical assessments (CAA) are generally more sensitive than clinical efficacy studies (CES) shows the great degree in which the agency is leaning on analytics rather than clinical data when considering 351(...
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.
Closing The Data Package Gap For In-House 3D Printed Parts
Vendor supplied single-use components come with mostly-complete data packages. That luxury doesn't exist when you make your own parts using a 3D printer.
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.
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 ...