|
|
|
FOCUS ON ANALYTICS & QUALITY |
|
|
|
By Matthew Pillar, Editor, Bioprocess Online
| Scale-up in all its iterations from bench to commercial readiness, tech transfer to an outsourced manufacturing partner, product acquisition, manufacturing equipment or consumables change, and even process development personnel turnover place analytical decisions made early on under a microscope. |
|
|
|
|
ANALYTICS & QUALITY SOLUTIONS |
|
|
|
|
|
| Webinar: How to Plan for Trouble-Free Filter Validation | Join Cytiva as they discuss regulatory expectations for process-specific filter validation in drug products requiring sterile filtration. Learn best practices for conducting process-specific filter studies, essential for marketing authorization applications such as NDA and MMA. Participants will learn about timing for validation, laboratory requirements, and strategies for successful implementation across various drug types, including monoclonal antibodies and advanced therapy medicinal products. Click here to learn more. |
|
|
|
|
By Minghua Liu, Ph.D., Eliquent Life Sciences | A CMC consultant shares learnings from recent interactions with FDA regulators. The discussion primarily addresses prophylactic mRNA-LNP vaccines, though many considerations apply equally to therapeutic mRNA-LNP applications. |
|
|
| Top 6 Reasons To Digitize Your Data | Infographic | IDBS UK HQ | Here are six reasons why digitizing your data is worth the time and effort needed to adjust to the vernacular and understand which steps to take first. |
|
|
|
|
|
| Connect With Bioprocess Online: |
|
|
|
