Considerations for operational space definition and optimization of a no ‐salt flowthrough hydrophobic interaction chromatography purification step
AbstractNo-salt flowthrough hydrophobic interaction chromatography (HIC) has been shown to effectively remove process and product-related impurities from bioprocess streams. In this publication, a panel of six antibodies has been used to demonstrate operating principles for the application of no-salt flowthrough HIC in antibody purification processes. The results indicate that no-salt flowthrough HIC provides robust aggregate clearance across operating conditions including flow rate, and variations in resin ligand density. Additionally, HMW reduction has an optimal pH range relative to the isoelectric point of each molecul...
Source: Biotechnology Progress - April 28, 2023 Category: Biotechnology Authors: Allyson Tucker Dilks,
Joanne Gilchrist,
Yik Lam,
Nathan Nicholes,
Brad Stanley Tags: RESEARCH ARTICLE Source Type: research
An adaptive modeling approach using spiking ‐augmentation method to improve chemometric model performance in bioprocess monitoring
In this study, we developed an adaptive modeling strategy: the model was initially built using a calibration set of available perfusate and CB samples and then updated by augmenting spiking samples of the new molecules to the calibration set to make the model robust against perfusate or CB harvest of the new molecule. This strategy substantially improved the model performance and significantly reduced the modeling effort for new molecules. (Source: Biotechnology Progress)
Source: Biotechnology Progress - April 27, 2023 Category: Biotechnology Authors: Yuxiang Zhao,
Yawen Tang,
Dhanuka Wasalathanthri,
Jianlin Xu,
Julia Ding Tags: RESEARCH ARTICLE Source Type: research
Real time on ‐line amino acid analysis to explore amino acid trends and link to glycosylation outcomes of a model monoclonal antibody
AbstractBioreactor parameters can have significant effects on the quantity and quality of biotherapeutics. Monoclonal antibody products have one particularly important critical quality attribute being the distribution of product glycoforms. N-linked glycosylation affects the therapeutic properties of the antibody including effector function, immunogenicity, stability, and clearance rate. Our past work revealed that feeding different amino acids to bioreactors altered the productivity and glycan profiles. To facilitate real-time analysis of bioreactor parameters and the glycosylation of antibody products, we developed an on...
Source: Biotechnology Progress - April 27, 2023 Category: Biotechnology Authors: Nicole Azer,
Nicholas Trunfio,
Erica J. Fratz ‐Berilla,
Jin Sung Hong,
Jackie Cullinan,
Talia Faison,
Cyrus D. Agarabi,
David N. Powers Tags: RESEARCH ARTICLE Source Type: research
Use of ultrafiltration/diafiltration for the processing of antisense oligonucleotides
AbstractUltrafiltration/diafiltration (UF/DF) has been the hallmark for concentrating and buffer exchange of protein and peptide-based therapeutics for years. Here we examine the capabilities and limitations of UF/DF membranes to process oligonucleotides using antisense oligonucleotides (ASOs) as a model. Using a 3 kDa UF/DF membrane, oligonucleotides as small as 6 kDa are shown to have low sieving coefficients (<0.008) and thus can be concentrated to high concentrations ( ≤200 mg/mL) with high yield (≥95%) and low viscosity (<15 centipoise), provided the oligonucleotide is designed not to undergo self-hyb...
Source: Biotechnology Progress - April 27, 2023 Category: Biotechnology Authors: Robert S. Gronke,
Krisada Ruanjaikaen,
Armin Delavari,
Jonas P. Immel ‐Brown,
Joseph C. Penrod,
Yik Lam,
Firoz D. Antia Tags: RESEARCH ARTICLE Source Type: research
Methods for identifying precipitates and improving stability of chemically defined highly concentrated cell culture media
AbstractCurrently, within the biopharmaceutical industry, media development is a key area of development as the ratios and concentrations of media components such as amino acids, metals, vitamins, sugars, salts, and buffering agents play arguably the largest role in cellular productivity and product quality. However, optimizing media for these targets often conflicts with solubility limitations and slow-rate chemical reactions that result in precipitation formation. Here we present methods such as inductively coupled plasma mass spectrometry (ICP-MS), X-ray fluorescence (XRF), colorimetry, and turbidity to identify multipl...
Source: Biotechnology Progress - April 17, 2023 Category: Biotechnology Authors: Taylor Forte,
Chris Grinnell,
An Zhang,
Brian Polilli,
John Leshinski,
Sarwat Khattak Tags: RESEARCH ARTICLE Source Type: research
Issue Information
(Source: Biotechnology Progress)
Source: Biotechnology Progress - April 16, 2023 Category: Biotechnology Tags: ISSUE INFORMATION Source Type: research
Modification of microstructure and selected physicochemical properties of bacterial cellulose produced by bacterial isolate using hydrocolloid ‐fortified Hestrin–Schramm medium
In this study, various hydrocolloids including modified starches (oxidized starch —1404 and hydroxypropyl starch—1440), locust bean gum, xanthan gum (XG), guar gum, and carboxymethyl cellulose were added to the Hestrin-Schramm medium to improve the production performance and microstructure of BC byGluconacetobacter entanii isolated from coconut water. After 14-day fermentation, medium supplemented with 0.1% carboxymethyl cellulose and 0.1% XG resulted in the highest BC yield with dry BC content of 9.82 and 6.06 g/L, respectively. In addition, scanning electron microscopy showed that all modified films have the chara...
Source: Biotechnology Progress - April 12, 2023 Category: Biotechnology Authors: Nhu ‐Ngoc Nguyen,
Thi Tuong Vi Tran,
Quoc‐Duy Nguyen,
Tran‐Phong Nguyen,
Tuyet‐Ngan Lien Tags: RESEARCH ARTICLE Source Type: research
Analytical characterization of host ‐cell‐protein‐rich aggregates in monoclonal antibody solutions
AbstractHost-cell proteins (HCPs) and high molecular weight (HMW) species have historically been treated as independent classes of impurities in the downstream processing of monoclonal antibodies (mAbs), but recent indications suggest that they may be partially linked. We have explored this connection with a shotgun proteomic analysis of HMW impurities that were isolated from harvest cell culture fluid (HCCF) and protein A eluate using size-exclusion chromatography (SEC). As part of the proteomic analysis, a cross-digest study was performed in which samples were analyzed using both the standard and native digest techniques...
Source: Biotechnology Progress - April 6, 2023 Category: Biotechnology Authors: Chase E. Herman,
Lie Min,
Leila H. Choe,
Ronald W. Maurer,
Xuankuo Xu,
Sanchayita Ghose,
Kelvin H. Lee,
Abraham M. Lenhoff Tags: RESEARCH ARTICLE Source Type: research
