|
|
|
|
| Regulators are shifting the biosimilar approval paradigm — prioritizing deep process understanding over large clinical trials. In this evolving landscape, defining and controlling CPPs is essential to demonstrating high similarity. Join Bioprocess Online’s Jon O’Connell on March 24th at 11 am Eastern for a live Q&A with Sarfaraz Niazi, Ph.D., Vince Narbut, and Diana Colleluori, Ph.D., as they explore how QbD and CQA insight can streamline development and regulatory success.. Register for free today thanks to support from sponsor Cytiva. |
|
|
|
|
By Better Biopharma | In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Richard Moroney, Ph.D., managing director at Stat Consulting. | |
|
|
|
|
FOCUS ON QUALITY/ANALYTICAL METHODS |
|
|
|
| Modeling Colorectal Cancer Progression | Webinar | Emulate | Gain a better understanding of the microenvironment's role in colorectal cancer progression by reviewing the integration of Organ-Chip models with high-content imaging and mass spectrometry. |
|
|
| AI Implementation To Enhance Quality | White Paper | By Seongil Cho, Hyeokgeon Kwon, and Kisung Shim, Samsung Biologics | Examine how solutions driven by artificial intelligence can enhance compliance, optimize workflows, and drive efficiency in biopharma operations. |
|
|
|
|
|
| Safeguarding Quality In Parenteral Drug Manufacturing | Article | InQuest Science | Observe how vision inspection software helps injectable drug manufacturers meet USP <790> standards by improving defect detection, ensuring data integrity, and eliminating paper-based risks. |
|
|
|
| PAT Monitoring And Control Roadmap | E-Book | BioPhorum | Learn how to implement PAT effectively with a roadmap that covers techniques, validation, data integrity, and lifecycle strategies to help teams improve quality, control, and productivity. |
|
|
| Using SEC For Reliable Biotherapeutic Peptide Analysis | Poster | By Philip Wuthrich, Stephan M. Koza, Stephen J. Shiner, et al., Waters Corporation | Uncover a breakthrough in analytical performance that delivers unmatched precision, faster results, and reduced waste. This innovation sets a new standard for sustainable, high-resolution analysis. |
|
|
|
| Logical Scale Out Before Scale Up | Article | RoosterBio | Read about how synthetic biology and a "scale-out" biomanufacturing strategy can unlock "infinite diversity in infinite combinations," optimizing MSC functionality for superior outcomes. |
|
|
|
| A Comparison Of Sizing And Quantification Performance | Application Note | Agilent Technologies | Review how automated electrophoretic analysis improves protein QC by delivering sharper sizing accuracy, stronger quantitative linearity, and greater consistency than conventional gel workflows. |
|
|
QUALITY/ANALYTICAL METHODS SOLUTIONS |
|
|
|
|
|
|
|
|
| Connect With Bioprocess Online: |
|
|
|