2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization).

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 companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 17th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines. Moreover, in-depth workshops on "EU IVDR 2017/746 Implementation and impact for the Global Biomarker Community: How to Comply with these NEW Regulations" and on "US FDA/OSIS Remote Regulatory Assessments (RRAs)" were the special features of the 17th edition. As in previous years, WRIB continued to gather a wide diversity of international, industry opinion leaders and regulatory authority experts working on both small and large molecules as well as gene, cell therapies and vaccines to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance, and achieving scientific excellence on bioanalytical issues. This 2023 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the 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 2023 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers the recommendations on Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity. Part 1A (Mass Spectrometry Assays and Regulated Bioanalysis/BMV), P1B (Regulatory Inputs) and Part 2 (Biomarkers, IVD/CDx, LBA and Cell-Based Assays) are published in volume 16 of Bioanalysis, issues 8 and 9 (2024), respectively.

An IQ Consortium Perspective on Best Practices for Bioanalytical and Immunogenicity Assessment Aspects of CAR-T and TCR-T Cellular Therapies Development.

CAR-T therapies have shown remarkable efficacy against hematological malignancies in the clinic over the last decade and new studies indicate that progress is being made to use these novel therapies to target solid tumors as well as treat autoimmune disease. Innovation in the field, including TCR-T, allogeneic or "off the shelf" CAR-T, and autoantigen/armored CAR-Ts are likely to increase the efficacy and applications of these therapies. The unique aspects of these cell-based therapeutics; patient-derived cells, intracellular expression, in vivo expansion, and phenotypic changes provide unique bioanalytical challenges to develop pharmacokinetic and immunogenicity assessments. The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Translational and ADME Sciences Leadership Group (TALG) has brought together a group of industry experts to discuss and consider these challenges. In this white paper, we present the IQ consortium perspective on the best practices and considerations for bioanalytical and immunogenicity aspects toward the optimal development of CAR-T and TCR-T cell therapies.

[Investigation of subjective well-being and influence factors among residents living in old districts in Wuhan, China].

OBJECTIVE: To investigate the subjective well-being and its influence factors among residents living in old districts in Wuhan. METHODS: In June, 2011, a total of 500 residents living in Shanghai Street in Wuhan were recruited as subjects for this study by two-stage stratified random sampling method. The information of demographic features, health status, spare time, family status, interpersonal relationship and social environment were collected by self-made questionnaires naming "survey of satisfaction of residents living in old districts". The results were analyzed by single-factor and multi-factors analysis method. RESULTS: In this study, 448 samples of questionnaire were answered qualified (89.6%, 448/500). The subjects aged (51.3 ± 16.1) years old. The single-factor analysis showed that male and female influence the subjective happiness got 5.43 ± 1.66, 5.77 ± 1.65 (U = -2.32, P < 0.05);the age of 0 - 45, 46 - 59, 60 and above group got 5.12 ± 1.68, 5.47 ± 1.81, 6.29 ± 1.23, respectively (H = 43.07, P < 0.01); the unmarried, married, divorced, loss of spouse and remarriage groups got 5.18 ± 1.94, 5.74 ± 1.54, 4.00 ± 2.04, 5.68 ± 1.91, 6.63 ± 0.92, respectively (H = 17.41, P < 0.01); education background were primary school and blow, junior middle school, senior high school, bachelor degree, master degree and above got 6.30 ± 1.42, 5.55 ± 1.82, 5.90 ± 1.46, 5.07 ± 1.74, 4.75 ± 2.22 (H = 26.99, P < 0.01); monthly household income was ¥0 - 2000, ¥2001 - 4000, ¥4001 - 8000, ¥8001 - 10 000, ¥10 000 and above got 5.34 ± 1.87, 5.68 ± 1.53, 6.20 ± 1.07, 7.33 ± 0.58, 6.00 ± 0.00, respectively (H = 13.85, P < 0.01). The subjective satisfaction of social environment ranked from high to low were: city public security (56.0%, 248/448), traffic environment (44.9%, 199/448), community environment (14.9%, 66/448), housing conditions (13.8%, 61/448) and medical environment (8.2%, 36/448). Multiple regression model suggested that the determinant coefficient was 0.53(P < 0.01), with a good degree of fitting. The model showed that the factors influencing the residents' happiness were ranked: social environment (ß' = 0.34), family status (ß' = 0.32), health status (ß' = 0.21), education background (ß'(0-6) school year = 0.00, ß'(7-9) school year = -0.12, ß'(9-12) school year = 0.04, ß'(>12) school year = -0.14), monthly household income (ß' = 0.07) and marital status (ß'(unmarried) = 0.00, ß'(married) = 0.03, ß'(divorced) = -0.03, ß'(widowed) = 0.01, ß'(remarried) = 0.02). CONCLUSION: The factors that social environment, family status, health status, education background, monthly household income and marital status could influence the subjective happiness of residents living in old districts in Wuhan. A perfect social security system could improve the subjective happiness of residents in old districts in Wuhan.