Technologies and Strategies for Bioanalysis of Biopharmaceuticals

Zhang, Yan J; An, Hyun Joo

doi:10.4155/bio-2017-4981

Cited by 6 publications

(4 citation statements)

References 28 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…While it is resource intensive to develop and validate ELISA methods to quantify mAb concentrations in tissues, the PK data generated using this method provides accurate measurement of the PK behaviour of mAbs. 24 Most tissue distribution studies for mAbs report total tissue concentrations. However, total tissue concentrations of mAb may not represent the "effective" concentration at the target site-ofaction (typically in the interstitial space of a tissue), which is required to predict drug efficacy and toxicity.…”

Section: Introductionmentioning

confidence: 99%

Whole-Body Pharmacokinetics of Antibody in Mice Determined using Enzyme-Linked Immunosorbent Assay and Derivation of Tissue Interstitial Concentrations

Chang

Kim

Shah

2021

Journal of Pharmaceutical Sciences

View full text Add to dashboard Cite

Here we have reported whole-body disposition of wild-type IgG and FcRn non-binding IgG in mice, determined using Enzyme-Linked Immunosorbent Assay (ELISA). The disposition data generated using ELISA are compared with previously published biodistribution data generated using radiolabelled IgG. In addition, we introduce a novel concept of ABC IS values, which are defined as percentage ratios of tissue interstitial and plasma AUC values. These values can help in predicting tissue interstitial concentrations of monoclonal antibodies (mAbs) based on the plasma concentrations. Tissue interstitial concentrations derived from our study are also compared with previously reported values measured using microdialysis or centrifugation method. Lastly, the new set of biodistribution data generated using ELISA are used to refine the PBPK model for mAbs.

show abstract

Section: Introductionmentioning

confidence: 99%

Whole-Body Pharmacokinetics of Antibody in Mice Determined using Enzyme-Linked Immunosorbent Assay and Derivation of Tissue Interstitial Concentrations

Chang

Kim

Shah

2021

Journal of Pharmaceutical Sciences

View full text Add to dashboard Cite

show abstract

“…Recommendations for this topic were last provided in the 2017 White Paper in Bioanalysis [17], and re-evaluated after 3 years of additional industry experience [38][39][40][41]. Discussions confirmed that hybrid assays for TE were being used frequently for both small and large molecules for internal decision-making purposes.…”

Section: Extracellular Vesiclesmentioning

confidence: 97%

“…Not only the reagent may cause dissociation of the drug-target complex, other factors include the binding affinity, binding off-rate, incubation conditions, or sample dilution. A small degree of dissociation from the highly abundant drug-target complex can result in significant overestimation of the free target [38,39]. Also, consideration should be given to the endogenous binding partners of the target when measuring free/total target; it is also well established that sample preparation steps can shift the equilibrium of drug binding (just like in LBA).…”

Section: Extracellular Vesiclesmentioning

confidence: 99%

2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome ( Part 1 –Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos)

et al. 2021

View full text Add to dashboard Cite

The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15–29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. The 14th WRIB included three Main Workshops, seven Specialized Workshops that together spanned 11 days in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccine. Moreover, a comprehensive vaccine assays track; an enhanced cytometry track and updated Industry/Regulators consensus on BMV of biotherapeutics by Mass Spectrometry (hybrid assays, LCMS and HRMS) were special features in 2020. As in previous years, this year's WRIB continued to gather a wide diversity of international industry opinion leaders and regulatory authority experts working on both small and large molecules to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance and achieving scientific excellence on bioanalytical issues. This 2020 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the Global Bioanalytical Community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2020 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication covers the recommendations on (Part 1) Hybrid Assays, Innovation in Small Molecules, & Regulated Bioanalysis. Part 2A (BAV, PK LBA, Flow Cytometry Validation and Cytometry Innovation), Part 2B (Regulatory Input) and Part 3 (Vaccine, Gene/Cell Therapy, NAb Harmonization and Immunogenicity) are published in volume 13 of Bioanalysis, issues 5, and 6 (2021), respectively.

show abstract

“…[116]. As biotherapeutic protein examination using LC-MS tool is a developing zone, this distinct focus matter in the presence of advances and deliberations of application of LC-MS for characterization along with quantification of therapeutic proteins [117]. Phenylalanine ammonia lyase has been derived from Rhodotorula rubia yeast, 4-Coumarate CoA ligase from bacteria S. coelicolor enzyme acetyl CoA carboxylase in addition to the stilbene synthase by Arachis hypogea.…”

Section: In Pharmacology and Pharmaceuticalsmentioning

confidence: 99%

Bioengineering tools for the production of pharmaceuticals: current perspective and future outlook

2019

View full text Add to dashboard Cite

The bioengineering tools have significant advantages through less time-consuming and utilized as a promising stage for the production of pharmaceutical bioproducts under the single platform. This review highlighted the advantages and current improvement in the plant, animal and microbial bioengineering tools and outlines feasible approaches by biological and process's bioengineering levels for advancing the economic feasibility of pharmaceutical's production. The critical analysis results revealed that system biology and synthetic biology along with advanced bioengineering tools like transcriptome, proteome, metabolome and nano bioengineering tools have shown a promising impact on the development of pharmaceutical's bioproducts. Tools to overcome and resolve the accompanying encounters of pharmaceutical's production that include nano bioengineering tools are also discussed. As a summary and prospect, it also gives new insight into the challenges and possible breakthrough of the development of pharmaceutical's bioproducts through bioengineering tools.

show abstract

Technologies and Strategies for Bioanalysis of Biopharmaceuticals

Cited by 6 publications

References 28 publications

Whole-Body Pharmacokinetics of Antibody in Mice Determined using Enzyme-Linked Immunosorbent Assay and Derivation of Tissue Interstitial Concentrations

Whole-Body Pharmacokinetics of Antibody in Mice Determined using Enzyme-Linked Immunosorbent Assay and Derivation of Tissue Interstitial Concentrations

Bioengineering tools for the production of pharmaceuticals: current perspective and future outlook

Contact Info

Product

Resources

About