The history and potential future of monoclonal antibody therapeutics development and manufacturing in four eras

ABSTRACT

Therapeutic monoclonal antibody (mAb) development and the processes for manufacturing drug substance have evolved since the first approval of the mAb in 1986. As the past is often the prologue to the future, the history of these technologies has been classified here into three eras, leading to speculation about what the next era may hold with regard to development and manufacturing strategies, as well as the potential impacts to patients. The substantial increase in production culture titers and bioreactor production volumes and the availability of large-scale contract manufacturing facilities could translate into improved global access for these therapies and an expansion of indications for therapeutic antibodies.

KEYWORDS:

• Cost of goods
• global access
• manufacturing

Acknowledgments

I want to acknowledge the memory of Michael Kamarck, a generational leader who inspired so many to excel at what we do in the biopharmaceutical industry. This paper is also dedicated to the hundreds of classmates, coworkers, colleagues, and friends who accompanied me on various parts of this journey since 1987. A special thanks to those who helped me with the final manuscript edits and content: Raj Gupta and Kristen Douglas.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Abbreviations

mAb	=	Monoclonal antibody
COGs	=	Cost of goods
TNF	=	Tissue necrosis factor
VLS	=	Very large scale
LMIC	=	Low and middle income countries

Additional information

Funding

The author(s) reported that there is no funding associated with the work featured in this article.