A5058448395- Protein purification and stability
- Viral Infectious Diseases and Gene Expression in Insects
- Monoclonal and Polyclonal Antibodies Research
- Virus-based gene therapy research
- Viral gastroenteritis research and epidemiology
- Microfluidic and Capillary Electrophoresis Applications
- Protein Structure and Dynamics
- Analytical Chemistry and Chromatography
- Innovative Microfluidic and Catalytic Techniques Innovation
- Bacteriophages and microbial interactions
- Nanopore and Nanochannel Transport Studies
- SARS-CoV-2 detection and testing
- Microbial Metabolic Engineering and Bioproduction
- Chromatography in Natural Products
- Protein Interaction Studies and Fluorescence Analysis
- Microfluidic and Bio-sensing Technologies
- Transgenic Plants and Applications
- Computational Drug Discovery Methods
- Construction Engineering and Safety
- Membrane Separation Technologies
- Viral Infections and Immunology Research
- Fluid Dynamics and Mixing
- Lattice Boltzmann Simulation Studies
- Crystallization and Solubility Studies
- BIM and Construction Integration
Merck & Co., Inc., Rahway, NJ, USA (United States)
2016-2025
Bioprocess Control (Sweden)
2023
Cell Biotech (South Korea)
2020
Weatherford College
2016
MSD K.K. (Japan)
2015
Villanova University
2005
University of Houston
1993-1995
The emergence of monoclonal antibody (mAb) therapies has created a need for faster and more efficient bioprocess development strategies in order to meet timeline material demands. In this work, high‐throughput process (HTPD) strategy implementing several chromatography purification techniques is described. Namely, batch incubations are used scout feasible operating conditions, miniature columns then determine separation impurities, and, finally, limited number lab scale tested confirm the...
Abstract Host‐cell proteins (HCPs) are the foremost class of process‐related impurities to be controlled and removed in downstream processing steps monoclonal antibody (mAb) manufacturing. However, some HCPs may evade clearance multiple purification reach final drug product, potentially threatening stability patient safety. This study extends prior work on HCP characterization persistence mAb process streams by using mass spectrometry (MS)‐based methods track through for seven mAbs that were...
Abstract Product association of host‐cell proteins (HCPs) to monoclonal antibodies (mAbs) is widely regarded as a mechanism that can enable HCP persistence through multiple purification steps and even into the final drug substance. Discussion this often implies existence or extent directly related strength binding but actual measurements affinity such interactions remain sparse. Two separate avenues investigation HCP‐mAb are reported here. One measurement individual, commonly persistent...
The growth of advanced analytics in manufacturing monoclonal antibodies (mAbs) has highlighted the challenges associated with clearance host cell proteins (HCPs). Of special concern is removal "persistent" HCPs, including immunogenic and mAb-degrading proteins, that co-elute from Protein A resin can escape polishing steps. Responding to this challenge, we introduced an ensemble peptide ligands target HCPs Chinese hamster ovary (CHO) culture fluids enable mAb purification via flow-through...
ADVERTISEMENT RETURN TO ISSUEPREVArticleNEXTProtein Adsorption Kinetics Drastically Altered by Repositioning a Single ChargeJ. J. Ramsden, D. Roush, S. Gill, R. Kurrat, and C. WillsonCite this: Am. Chem. Soc. 1995, 117, 33, 8511–8516Publication Date (Print):August 1, 1995Publication History Published online1 May 2002Published inissue 1 August 1995https://pubs.acs.org/doi/10.1021/ja00138a003https://doi.org/10.1021/ja00138a003research-articleACS PublicationsRequest reuse permissionsArticle...
Abstract The large scale production of monoclonal antibodies presents a challenge to design efficient and cost effective downstream purification processes. We explored two stage resin screening approach identify the best candidates be utilized for platform antibodies. study focused on commercially available affinity resins including Protein A, mimetic mixed‐mode interaction as well ion exchangers used in polishing steps. An initial using pure proteins was followed by final where selected...
Clearance of aggregates during protein purification is increasingly paramount as represent one the major impurities in biopharmaceutical products. Aggregates, especially dimer species, a significant challenge for processing since aggregate separation coupled with high purity recovery can be difficult to accomplish. Biochemical characterization species from hydrophobic interaction and cation exchange chromatography elution peaks revealed two different charged populations, i.e. heterogeneous...
Considerable resources are spent within the biopharmaceutical industry to perform viral clearance studies, which conducted for widely used unit operations that known have robust and effective retrovirus capability. The collaborative analysis from members of BioPhorum Development Group Viral Clearance Working Team considers two common virus reduction steps in processes: low-pH inactivation filtration. Analysis included eight parameters nine extensive data set presented this paper provides...
Abstract The increased cell density and product titer in biomanufacturing have led to greater use of depth filtration as part the initial clarification culture fluid, either a stand‐alone unit operation or after centrifugation. Several recent studies shown that filters can also reduce concentration smaller impurities like host proteins (HCP) DNA, decreasing burden on subsequent chromatographic operations. objective this study was evaluate HCP removal properties Pall PDH4 filter media, model...
Abstract In the production of biopharmaceuticals such as monoclonal antibodies (mAbs) and vaccines, residual amounts host‐cell proteins (HCPs) are among critical quality attributes. addition to overall HCP levels, individual HCPs may elude purification, potentially causing issues in product stability or patient safety. Such persistence has been attributed mainly biophysical interactions between product, resin media, chromatin particles. Based on measurements process streams from seven mAb...
Abstract The fifth modeling workshop (5MW) was held in June 2023 at Favrholm, Denmark and sponsored by Recovery of Biological Products Conference Series. goal the to assemble practitioners review discuss current state, progress since last fourth mini (4MMW), gaps opportunities for development, deployment maintenance models bioprocess applications. Areas focus were four categories: biophysics molecular modeling, mechanistic computational fluid dynamics (CFD) plant modeling. Highlights...
The ability to process high-concentration monoclonal antibody solutions (> 10 g/L) through small-pore membranes typically used for virus removal can improve current purification processes by eliminating the need feed stream dilution, and reducing filter area, cycle-time, costs. In this work, we present screening of filters varying configurations materials construction using MAb with a concentration range 4-20 g/L. For our MAbs interest-two different humanized IgG1s-flux decay was not...
Controlling viral contamination is an important issue in the process development of monoclonal antibodies (MAbs) produced from mammalian cell lines. Virus filtration (VF) has been demonstrated to be a robust and effective clearance step which can provide ≥4 logs reduction via size exclusion. The minimization VF area by increasing flux filter loading critical achieving cost targets as VFs are single use often represent up 10% total purification costs. research presented this publication...