Bioanalytical strategy for the characterization and bioanalysis of biologics: a global, nonregulated bioanalytical lab perspective
H Sarvaiya, S Niu, DT Ladror, Y Wang, D Maji… - Bioanalysis, 2023 - Taylor & Francis
Over the past two decades, we have seen an increase in the complexity and diversity of
biotherapeutic modalities pursued by biopharmaceutical companies. These biologics are …
biotherapeutic modalities pursued by biopharmaceutical companies. These biologics are …
Advances and opportunities in process analytical technologies for viral vector manufacturing
SA Sripada, M Hosseini, S Ramesh, J Wang… - Biotechnology …, 2024 - Elsevier
Viral vectors are an emerging, exciting class of biologics whose application in vaccines,
oncology, and gene therapy has grown exponentially in recent years. Following first …
oncology, and gene therapy has grown exponentially in recent years. Following first …
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors …
L Pan, J Mora, K Walravens, L Wagner, S Hopper… - Bioanalysis, 2023 - Taylor & Francis
Abstract The 2022 16th Workshop on Recent Issues in Bioanalysis (WRIB) took place in
Atlanta, GA, USA on September 26–30, 2022. Over 1000 professionals representing …
Atlanta, GA, USA on September 26–30, 2022. Over 1000 professionals representing …
2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare …
M Szapacs, W Jian, D Spellman, J Cunliffe… - Bioanalysis, 2023 - Taylor & Francis
Abstract The 16th Workshop on Recent Issues in Bioanalysis (16th WRIB) took place in
Atlanta, GA, USA on September 26–30, 2022. Over 1000 professionals representing …
Atlanta, GA, USA on September 26–30, 2022. Over 1000 professionals representing …
2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in …
G Sumner, S Keller, J Huleatt, RF Staack, L Wagner… - Bioanalysis, 2023 - Taylor & Francis
The 16th Workshop on Recent Issues in Bioanalysis (16th WRIB) took place in Atlanta, GA,
USA on September 26–30, 2022. Over 1000 professionals representing pharma/biotech …
USA on September 26–30, 2022. Over 1000 professionals representing pharma/biotech …
Enhanced Pharmacokinetic Bioanalysis of Antibody–drug Conjugates using Hybrid Immunoaffinity Capture and Microflow LC-MS/MS
M Suh, JB Powers, CM Daniels, Y Wu - The AAPS Journal, 2023 - Springer
The increasing complexity and diversity of antibody–drug conjugates (ADCs) have led to a
need for comprehensive and informative bioanalytical methods to enhance pharmacokinetic …
need for comprehensive and informative bioanalytical methods to enhance pharmacokinetic …
Absolute quantitation of binding antibodies from clinical samples
C Tang, A Verwilligen, J Sadoff, B Brandenburg… - npj Vaccines, 2024 - nature.com
The quantitation of antibody responses is a critical requirement for the successful
development of vaccines and therapeutics that often relies on the use of standardized …
development of vaccines and therapeutics that often relies on the use of standardized …
Criteria of slope and endogenous level for selection of matrix in the quantitation of endogenous compounds by LC-MS/MS
AJ Ji, G Xu, L Tao, HJ Jiao, RE Palmer - Bioanalysis, 2022 - Taylor & Francis
Selection of the appropriate matrix for standard curve is critical for an accurate and sensitive
biomarker method. Slope of a standard curve is the key factor for parallelism assessment …
biomarker method. Slope of a standard curve is the key factor for parallelism assessment …
2023 White Paper on Recent Issues in Bioanalysis: Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral …
M Baratta, W Jian, S Hengel, S Kaur, J Cunliffe… - Bioanalysis, 2024 - Taylor & Francis
The 17th Workshop on Recent Issues in Bioanalysis (17th WRIB) took place in Orlando, FL,
USA on June 19–23, 2023. Over 1000 professionals representing pharma/biotech …
USA on June 19–23, 2023. Over 1000 professionals representing pharma/biotech …
2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry …
O Kholmanskikh, YM Wang, S Hersey, M Wadhwa… - Bioanalysis, 2024 - Taylor & Francis
The 17th Workshop on Recent Issues in Bioanalysis (17th WRIB) took place in Orlando, FL,
USA on 19–23 June 2023. Over 1000 professionals representing pharma/biotech …
USA on 19–23 June 2023. Over 1000 professionals representing pharma/biotech …