Filtration Methods for Use in Purification Processes (Concentration and Buffer Exchange)

Liderfelt, Jakob; Royce, Jonathan

doi:10.1016/b978-0-08-100623-8.00023-2

Cited by 2 publications

(1 citation statement)

References 22 publications

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“…The additional chromatographic steps unavoidably apply the mAb product to buffers of varying ionic strength and high concentrations, which can again induce mild mAb instability and aggregation. Post polishing steps, the purified mAb product undergoes a further viral removal step, such as filtration, and then it undergoes buffer exchange and concentration through ultrafiltration or diafiltration methods to prepare the bulk mAb product for formulation [100,105].…”

Section: Mab Discovery and Manufacture Technologiesmentioning

confidence: 99%

Current Advancements in Addressing Key Challenges of Therapeutic Antibody Design, Manufacture, and Formulation

et al. 2019

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Therapeutic antibody technology heavily dominates the biologics market and continues to present as a significant industrial interest in developing novel and improved antibody treatment strategies. Many noteworthy advancements in the last decades have propelled the success of antibody development; however, there are still opportunities for improvement. In considering such interest to develop antibody therapies, this review summarizes the array of challenges and considerations faced in the design, manufacture, and formulation of therapeutic antibodies, such as stability, bioavailability and immunological engagement. We discuss the advancement of technologies that address these challenges, highlighting key antibody engineered formats that have been adapted. Furthermore, we examine the implication of novel formulation technologies such as nanocarrier delivery systems for the potential to formulate for pulmonary delivery. Finally, we comprehensively discuss developments in computational approaches for the strategic design of antibodies with modulated functions.

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Section: Mab Discovery and Manufacture Technologiesmentioning

confidence: 99%

Current Advancements in Addressing Key Challenges of Therapeutic Antibody Design, Manufacture, and Formulation

et al. 2019

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Selective Plate-Based Assay for Trace EDTA Analysis via Boron Trifluoride-methanol Derivatization UHPLC-QqQ-MS/MS Enabling Biologic and Vaccine Processes

et al. 2021

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The employment of ethylenediaminetetraacetic acid (EDTA) across several fields in chemistry and biology has required the creation of a high number of quantitative assays. Nonetheless, the determination of trace EDTA, especially in biologics and vaccines, remains challenging. Herein, we introduce an automated high-throughput approach based on EDTA esterification in 96-well plates using boron trifluoride-methanol combined with rapid analysis by ultra-high-performance liquid chromatography–triple quadrupole tandem mass spectrometry (UHPLC-QqQ-MS/MS). Derivatization of EDTA to its methyl ester (Me-EDTA) serves to significantly improve chromatographic performance (retention, peak shape, and selectivity), while also delivering a tremendous enhancement of sensitivity in the positive ion mode electrospray ionization (ESI+). This procedure, in contrast to previous EDTA methods based on complexation with metal ions, is not affected by high concentration of other metals, buffers, and related salts abundantly present in biopharmaceutical processes (e.g., iron, copper, citrate, etc.). Validation of this assay for the determination of ng·mL–1 level EDTA in monoclonal antibody and vaccine products demonstrated excellent performance (repeatability, precision, and linear range) with high recovery from small sample volumes while also providing an advantageous automation-friendly workflow for high-throughput analysis.

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Filtration Methods for Use in Purification Processes (Concentration and Buffer Exchange)

Cited by 2 publications

References 22 publications

Current Advancements in Addressing Key Challenges of Therapeutic Antibody Design, Manufacture, and Formulation

Current Advancements in Addressing Key Challenges of Therapeutic Antibody Design, Manufacture, and Formulation

Selective Plate-Based Assay for Trace EDTA Analysis via Boron Trifluoride-methanol Derivatization UHPLC-QqQ-MS/MS Enabling Biologic and Vaccine Processes

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