Application Notes & Case Studies
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Successful DPM Manufacturing- Development To Large-Scale cGMP Production
7/25/2024
This study showcases the success of a two-phase scale-up strategy for the production of dry powder medium (DPM).
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Harmonizing Regulatory Guidelines For Assay Validation
7/24/2024
Explore a detailed process for validating ligand-binding assays, particularly for Fcγ receptor binding analytes or other structural isoforms.
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The Digital Transformation Of Catalent's Process Development Laboratory
7/16/2024
Discover how Catalent was able to create a data model for its bioreactors, resulting in easily contextualized data, time savings in manual tasks, and the ability to share insights in real time.
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Part 1: Intuitive Bioprocess Scale-Up From Bench Scale To Pilot Scale
7/10/2024
Transitioning from bench to pilot scale in bioproduction is critical. This study showcases the DynaDrive S.U.B.'s ability to maintain key performance indicators while scaling up from a 3L glass bioreactor to a 50L system.
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What Changes When Your CPV Goes Digital
7/10/2024
Explore the advantages of digitalizing Continued Process Verification (CPV) through the experience of a pharmaceutical company step-by-step.
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Bypassing The Challenges Of Paper-Based Validation
7/10/2024
Gain insight into why a biotechnology startup and CDMO views investment in a digitized validation lifecycle management system as crucial for accelerating innovation and reducing time to market.
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Seizing The Opportunity To Go Paperless
7/10/2024
Learn how specialty pharmaceutical company Noven Pharmaceuticals successfully launched a new computer system validation by upgrading their enterprise resource planning system.
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TFF Cassettes With 100 kDa Membranes For RNA And LNP Applications
7/3/2024
Explore data showcasing the performance of regenerated cellulose flat sheet membranes with a 100 kDa molecular weight cutoff for UF/DF of RNA molecules by TFF.
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Accelerating Bulk Harvest Release Testing With A PCR-Based Solution
7/3/2024
Adventitious agent testing is frequently a bottleneck in downstream processing. Discover a PCR-based solution for manufacturing processes using CHO cells and animal origin-free components.
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Seizing Market Share Pre-Patent Expiry: The Evolution Of A CDMO Partnership In Navigating A Paragraph IV ANDA Submission
6/26/2024
The dynamic pharmaceutical landscape demands agility and strategic foresight. Explore how leveraging a key partnership helped to overcome a looming patent expiry for a second-generation acne medication.