Bridging the gap: facilities and technologies for development of early stage therapeutic mAb candidates.

Abstract:

:Therapeutic monoclonal antibodies (mAbs) currently dominate the biologics marketplace. Development of a new therapeutic mAb candidate is a complex, multistep process and early stages of development typically begin in an academic research environment. Recently, a number of facilities and initiatives have been launched to aid researchers along this difficult path and facilitate progression of the next mAb blockbuster. Complementing this, there has been a renewed interest from the pharmaceutical industry to reconnect with academia in order to boost dwindling pipelines and encourage innovation. In this review, we examine the steps required to take a therapeutic mAb from discovery through early stage preclinical development and toward becoming a feasible clinical candidate. Discussion of the technologies used for mAb discovery, production in mammalian cells and innovations in single-use bioprocessing is included. We also examine regulatory requirements for product quality and characterization that should be considered at the earliest stages of mAb development. We provide details on the facilities available to help researchers and small-biotech build value into early stage product development, and include examples from within our own facility of how technologies are utilized and an analysis of our client base.

journal_name

MAbs

journal_title

mAbs

authors

Munro TP,Mahler SM,Huang EP,Chin DY,Gray PP

doi

10.4161/mabs.3.5.16968

subject

Has Abstract

pub_date

2011-09-01 00:00:00

pages

440-52

issue

5

eissn

1942-0862

issn

1942-0870

pii

16968

journal_volume

3

pub_type

杂志文章,评审

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