REGULATORY
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.
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.
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.
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.
Faciliflex Cleanroom Module For Therapeutic Drug Manufacturing
The Faciliflex Module is a transformational new concept in designing cleanrooms for the production of lifesaving therapeutics.
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.
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.
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...
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.
Multi-Specific Antibody Development: What Challenges The Need For Speed?
In this segment of the Bioprocess Online Live event, Process Development For A Diverse mAb Pipeline, Bayer’s Sr. Director, Bioprocess Technologies, Amir Goudarzi, Ph.D., addresses why the industry is pursuing faster, more cost-effective multi-specific antib...
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...
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.
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.
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.
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...
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.
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 ...
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.
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.
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.
Strategies To Reduce Regulatory Risks In Gene Therapy
Learn how to mitigate regulatory risk for your gene therapy process.
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.
Legal & Compliance Impact On Speed In The Antibody Market
In this segment of the Bioprocess Online Live event, Process Development For A Diverse mAb Pipeline, Bayer’s Sr. Director, Bioprocess Technologies, Amir Goudarzi, Ph.D., addresses questions on regulatory impacts on multi-specific antibodies’ path to m...
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'...
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.
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.
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...
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.