Bioconjugate therapeutics comprise a fast-growing class of drugs with applications in various disease areas. In the past years, particularly antibody-drug conjugates (ADCs) have undergone a period of great success with eight products approved by the Food and Drug Administration (FDA) between 2019-2022 alone. The rapid emergence of novel bioconjugation technologies, payloads and linkers as well as their application on different protein modalities has made bioconjugate development and manufacturing increasingly complex. Clinical success of bioconjugates depends on the delicate interplay between the protein, linker and payload, which is often not readily predictable. Therefore, it is important to consider a range of different technologies when designing a bioconjugate drug. Since navigation of a constantly evolving technology landscape is challenging, it may be beneficial for many biotech companies to enter partnerships with a contract development and manufacturing organization (CDMO) that can help realize the drug concept by providing access to a range of tools for the development of bioconjugates. Partnering with a CDMO at an early-stage of drug development can greatly de-risk the program as the right CDMO can give guidance on how to design a conjugation process that not only fulfills the requirements in terms of product attributes but that is also robust enough to streamline further process development and upscale for moving towards an IND filing.
Authors: Nina Hentzen Ph.D.1, Abbas El Sahili, Ph.D.,2, Prof. Julien Lescar, Ph.D.,2 Prof. Chuan Fa Liu, Ph,D., 2 & Raphael Frey, Ph.D.1
Corresponding Author: Raphael Frey, Ph.D.
Key terms: ADC, bioconjugation, bioconjugation techniques, early development
Published In: ADC Review| Journal of Antibody-drug Conjugates
How to cite:
Nina Hentzen1, Abbas El Sahili2, Julien Lescar2, Chuan Fa Liu2 & Raphael Frey1
Bioconjugation Technology Selection during Early-Stage Development – A Strategy to Streamline IND and Manufacturing Timelines – J. ADC. May 26, 2023. DOI: 10.14229/jadc.2023.07.10.002.
1 Early Development Bioconjugates Services, Lonza, Switzerland
2 Singzyme Pte. Ltd., Singapore
Last Editorial Review: June 16, 2023
- Original Manuscript Received May 11, 2023
- Review results received June 19, 2022
- Manuscript accepted for publication July 3, 2023
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