REGULATORY
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...
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.
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.
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.
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.
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.
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.
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...
In The U.S., Pharmacy-Level Biosimilar Substitution Remains A High Bar
Recent changes in the FDA's biosimilarity assessment guidance do not address the other side of the biosimilar coin, interchangeability. Unique to the U.S., pharmacy-level substitution is allowed only when companies clear an additional regulatory hurdle of receiving an...
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.
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'...
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.
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...
Strategies To Reduce Regulatory Risks In Gene Therapy
Learn how to mitigate regulatory risk for your gene therapy process.
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.
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.
Faciliflex Cleanroom Module For Therapeutic Drug Manufacturing
The Faciliflex Module is a transformational new concept in designing cleanrooms for the production of lifesaving therapeutics.
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...
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(...
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.
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 ...
Cell And Gene Therapy Innovations
This interview with a pharmaceutical analytics expert discusses key insights into advances in cell and gene therapy and the strategies used to support customers in improving their therapeutic development.
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.
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...
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.
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.
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.
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.
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.