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

Author:

Gokemeijer Jochem1ORCID,Balasubramanian Nanda2,Ogasawara Ken2ORCID,Grudzinska‐Goebel Joanna3,Upreti Vijay V.4,Mody Hardik5,Kasar Siddha6,Vepachedu Venkata R.7ORCID,Xu Weifeng8,Gupta Swati9ORCID,Tarcsa Edit10ORCID,Dodge Robert11,Herr Kate7,Yang Tong‐Yuan7ORCID,Tourdot Sophie12,Jawa Vibha2

Affiliation:

1. Discovery Biotherapeutics, Bristol Myers Squibb Cambridge Massachusetts USA

2. Clinical Pharmacology, Pharmacometrics & Bioanalysis, Bristol Myers Squibb Lawrenceville New Jersey USA

3. Pharmaceuticals R&D, Bayer AG Berlin Germany

4. Clinical Pharmacology, Modeling & Simulation, Amgen, Inc. South San Francisco California USA

5. Clinical Pharmacology, Genentech Inc. South San Francisco California USA

6. Oncology Precision & Translational Medicine, Takeda Pharmaceuticals Cambridge Massachusetts USA

7. Bioanalytical Discovery & Development Sciences, Johnson & Johnson Innovative Medicine Spring House Pennsylvania USA

8. Preclinical Development, Bioanalytical, Merck & Co., Inc. Rahway New Jersey USA

9. Development Biological Sciences, Immunology, AbbVie Irvine California USA

10. Abbvie Bioresearch Center Worcester Massachusetts USA

11. Novartis Institutes for BioMedical Research, One Health Plaza East Hanover New Jersey USA

12. BioMedicine Design, Pfizer Inc. Andover Massachusetts USA

Abstract

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.

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Cited by 1 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

1. Best Practices for Pharmacokinetic Studies of New Chemical Entities;Clinical Pharmacology & Therapeutics;2024-04-17

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