Biosimilar App Notes & Case Studies
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Optimizing Recovery On The Sepax™ Cell Processing System
7/21/2022
Using a model T-cell line, we demonstrate the impact of varying rinse volume, intermediate volume, and manual extraction parameters on overall cell recovery with a final product dose volume of 20 mL.
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How To Protect A Modern Silicone Oil-Sensitive Biologic Drug For Self-Injection Of 2.25mL
4/25/2023
A customer experienced expensive project delays when they selected their “tried and tested” large volume, glass syringe system to package a drug to be used in an auto-injector for self-administration.
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Capture Of Bispecific Antibodies And Removal Of Product-Related Impurities
11/17/2022
Many antibody variants are prone to aggregation or to forming product-related impurities. Explore the application of a resin with novel selectivity to purify challenging entities.
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Alkaline Stability Of Modern Protein A Chromatography Resins
7/12/2023
Explore results from a resin lifetime study with over 150 cycles, using clarified cell harvest in every cycle, which has been performed to evaluate the alkaline stability of three protein A resins.
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Simplifying CHO Cell Line Genetic Stability Testing
4/11/2024
Here, we describe the use of whole genome sequencing to perform a comprehensive assessment of genetic stability in clonally derived CHO cell banks using the Aptegra™ CHO genetic stability assay.
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Natural Killer Cells Manufacturing
7/22/2022
Follow the feasibility of xeno‑free NK cell expansion, closure of key unit operations, and how future work could focus on fine‑tuning each step to generate a robust, scalable process.
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Process Control And Performance Of A Depth Filtration System
1/24/2023
Explore a demonstration of strategic process control in terms of flow and pressure, by utilizing a depth filtration system, for effective depth filter processing and recovery of excess product.
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Process Optimization And Scalability Evaluation Of Pellicon® Capsules For SPTFF Of mAb-Based Biomolecules
6/17/2022
This document describes the principles of SPTFF and how to determine operating conditions to achieve the target concentration factor with single-use Pellicon® Capsules.
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Characterization Of Host Cell Proteins By Liquid Chromatography - Mass Spectrometry
2/26/2024
Explore an established liquid chromatography – tandem mass spectrometry (LC-MS/MS) method for characterization of residual HCPs in monoclonal antibody (mAb) products.
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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.