flexible, efficient Non-GMP antibody production services to advance the development of increasing number of therapeutic monoclonal antibody candidates, from process development to aseptic filling https://www.creativebiolabs.net/non-gmp-antibody-production.htm

1. CREATIVE BIOLABS • RECOMBINANT ANTIBODY
45-1 Ramsey Road, Shirley, NY 11967, USA
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Four major mAb types have been developed, murine antibody, chimeric antibody, humanized antibody,
and human antibody, according to its increasing content of human sequence (Fig. 1). Initial therapeutic
antibodies were murine mAbs (suffix –omab). The first marketed antibody drug, muromonab-CD3
(OrthocloneOKT3®), was a fully mouse-derived antibody. It has been shown that these antibodies have
many defect, such asshort half-life time in vivo, limited penetration into tumor sites, high
immunogenicity, etc. To overcome these difficulties, chimeric (suffix - ximab) and humanized mAbs
(suffix - zumab) have been developed from murine mAbs in a modern therapeutic antibody context.
Chimeric mAbs are composed of murine variable regions fused onto human antibody constant regions
and contain approximately 65% human sequences. It significantly reduces immunogenicity and increases
the Fc effector function as well as the serum half-life. Rituximab (Rituxan®), infliximab (Remicade®), and
cetuximab (Erbitux®) are examples of marketed chimeric antibodies. Note that each of their generic
names end in the suffix “- ximab”. Humanized antibodies produced by grafting murine complementarity
determining regions (CDRs) have approximately 95% human origin. Omalizumab (Xolair®), trastuzumab
(Herceptin®) and bevacizumab (Avastin®) are examples of humanized antibodies on the market. Note
that each of their generic names end in the suffix “-zumab.” Complete human mAbs (100% human
sequence, suffix - umab) coding sequences can be obtained from single human B cell PCR, phage display
of human B cell repertoires, or human Ig loci transgenic mouse immunized with the desiredantigen.
Adalimumab (Humira®), panitumumab (Vectabix®), ustekinumab (Stelara®), and golimumab (Simponi®)
are examples of fully human antibodies that have been successfully marketed. Note that each of their
names ends in the suffix “-umab.”
The generic names for the antibodies mentioned above are not random. Antibody drug nomenclature
follows the rule of the World Health Organization’s International Nonproprietary Names (INN). The
general scheme of a generic name for a mAb drug is Prefix–target–source–suffix. The names are
essentially split into four parts: (1) a unique prefix; (2) affix letters identifying the type of target; (3) affix
letters indicating the original source of the variable chains, e.g. human, mouse, etc.; (4) how those V-
regions are engineered, as noted above, e.g. chimeric, humanized, or fully human (Figure. 1) and (iv) the
suffix “mab” (Table. 2). For example, rituximab is the generic name for anti‐CD20 mAb drug Rituxan. Its
name is composed of prefix ri‐, plus target stem ‐tu‐, plus source stem ‐xi‐, plus suffix - mab. These shows
that the drug is a chimeric mAb acting against tumors.
-momab -ximab -zumab -umab
Fig. 1 Classification of therapeutic mAb according to its increasing content of human sequence.
The Classification and Naming of
Therapeutic Monoclonal Antibodies