Therapeutic Fc‐Fusion Proteins 2013
DOI: 10.1002/9783527675272.ch01
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Introduction: Antibody Structure and Function

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Cited by 7 publications
(10 citation statements)
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“…Fcfusion products have demonstrated inferior stability compared to naturally existing antibodies and thus require additional stabilizers in their lyophilized formulations. The structural compatibility between Tc and Fc regions has been discussed among possible sources of instability [6,19]. Likewise, the conjugation of antibodies with small molecule pharmaceuticals results in less stable molecules than the original antibodies.…”
Section: Strategy For Different Modality Of Biologicsmentioning
confidence: 98%
See 1 more Smart Citation
“…Fcfusion products have demonstrated inferior stability compared to naturally existing antibodies and thus require additional stabilizers in their lyophilized formulations. The structural compatibility between Tc and Fc regions has been discussed among possible sources of instability [6,19]. Likewise, the conjugation of antibodies with small molecule pharmaceuticals results in less stable molecules than the original antibodies.…”
Section: Strategy For Different Modality Of Biologicsmentioning
confidence: 98%
“…These justifications must be based on relevant methods and results to evaluate the effect of the change as related to the product's safety or effectiveness (Appendix Regulatory Documents [18][19][20]. Although changes in degradation profiles after formulation modifications are undesirable, if the degradation profile changes qualitatively or quantitatively it is recommended to follow the impurity-related guidelines (Appendix Regulatory Documents 2,3).…”
Section: Strategy To Switch Formulationsmentioning
confidence: 99%
“…Antibodies are composed of two light chains and two heavy chains that assemble into two antigen-binding regions and a single constant region in a Y-shaped configuration . There are two types of light chains (λ and κ) and five types of heavy chains (α, δ, ε, γ, and μ) .…”
Section: Introductionmentioning
confidence: 99%
“…FAB is the antigen binding fragment which consists of variable region of heavy chain and light chain (VH and VL) and constant region [5]. Complementary determining region of variable region have loops involve in the interaction to the antigen [6,7].…”
Section: Introduction Vdj Recombinationmentioning
confidence: 99%