Outsourced Pharma App Notes & Case Studies
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Evaluating Milling Conditions For Scaling Up A Nanosuspension Drug Product
1/9/2024
Aiming to obtain a target particle size to support Phase 3 clinical trials, uncover how this study contributed insights on nanosuspension drug product production at escalated scales.
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Next Generation Sequencing For Adventitious Agent Detection In Cell Banks
2/23/2023
NGS-based methods for agnostic broad range detection are suitable options to augment or replace current virus testing methodology. Explore a NGS AAT method for cell line characterization and more.
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Advancing Your API To First Human Dose Trials More Efficiently
2/7/2024
Learn how end-to-end support for development and manufacturing, clinical trial services, advanced drug delivery, and commercial packaging can accelerate drug development and time to market.
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Development Of A Novel Cell Culture Medium For AAV Production
9/26/2023
Explore the medium development process of a novel cell culture medium for AAV production with multiple HEK293 lineages, which was performed with three different HEK293 cell lines to maximize AAV titers.
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Establishing A Robust Workflow To Identify High-Performing Clones
1/13/2023
Cell line development is a complex, labor intensive, and multistep process. Learn about a platform and host cell line that minimize the risk and timeline to develop high-performing clones.
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Optimizing The Formulation For A Monoclonal Antibody
8/21/2023
An emerging biotech company sought help developing a formulation for a monoclonal antibody. Explore how MilliporeSigma delivered an optimized formulation within an aggressive timeline and budget.
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Risk Mitigation Through Dual Sourcing Strategy
8/22/2022
A global biopharmaceutical company with a high value, highly potent drug product for a rare disease indication approached a CDMO to secure supply for a life-changing commercial drug product.
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Nanomilling From Screening To Scale-Up
1/8/2024
This investigation highlights the strategic use of nanotechnology to overcome formulation challenges and optimize the therapeutic potential of the drug in preparation for clinical trials.
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Understanding The Microfluidic Platforms For Scaling Nanoparticle Production
10/13/2022
Learn about the benefits of microfluidics for nanoparticle production over traditional methods as well as scaling nanoparticle production for clinical or industrial use.
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Recombinant Adeno-Associated Virus Type 5 Production Process
10/12/2022
Learn about a scalable process for the production of rAAV using triple plasmid transfection of suspension cells in an animal-derived component-free medium.