Review for ADC production, quality control and functional assay
Virus-like particles (VLP) Platforms for immunogens, vaccines and drug carriers
Antibody-drug Conjugate (ADC): Pre-made ADC benchmark, MOA, Production and QC
Neutralizing antibodies of virus (SARS2, HIV, HBV, Rabies, RSV, Ebola, Influenza)
Immunoglobulin Fc receptors for Fc&Fc Receptor binding assay
ILIBRA-HuEasy Monoclonal antibody (mab) humanization service (fully humanized ab)
Single domain antibody (Nanobody)
SOCAIL MEDIA
SDS-PAGE
We need run SDS-PAGE(reducing and non-reducing DTT) to see the integrity of antibody and Preliminary observation of the connection of small molecules. In general, we can see that the conjugated antibody will shift upward compared with the naked antibody
DAR (methods and standard)
ADC drugs are essentially a mixture, which is composed of mAbs connecting different numbers of small molecule drugs. Dar represents the average number of small molecule drugs connected to each mAb. Dar directly affects the efficacy and safety of ADC drugs. In the drug development stage, the variation range of DAR value should be minimized. The coupling sites of ADC drugs are divided into amino groups on lysine residues and sulfhydryl groups on cysteine residues. The DAR coupled by lysine is often small, but there are many potential coupling sites. The coupling reaction is random and the product heterogeneity is large; There are 4 pairs of inter chain disulfide bonds used in the development of ADC drugs. The antibody converts the inter chain disulfide bond into free cysteine residues through partial reduction. The sulfhydryl group in the cysteine residues reacts with the maleimide group in the linker to form ADC. Currently, most ADCs in use or under development rely on interchain disulfide cysteines for conjugation, in which the 4 (IgG1 and IgG4) or 6 (IgG2) interchain disulfide bonds are reduced by an excess reducing agent, namely tris(2-carboxyethyl)phosphine or dithiothreitol.153 This spares disruption of intrachain disulfide bonds while freeing sulfhydryl groups from cysteine residues participating in interchain disulfide bonds (Figure 3e). The resulting product is a mixture of ADCs containing 0–8 drugs per parent IgG1 or IgG4 and 0– 12 per IgG2, with predominantly even numbered DAR (0, 2, 4, 6, 8, 10, 12) species within the ADC mixture.
Ultraviolet / visible spectroscopy (UV / VIS)
UV / Vis spectroscopy is the simplest and stable method to detect Dar value. This method requires antibodies and small molecule drugs to have different maximum absorption wavelengths, and calculate their concentrations respectively to obtain the DAR value of ADC, which is suitable for a variety of ADCs.
Chromatography
Chromatography includes hydrophobic interaction chromatography (HIC) and reverse phase high performance liquid chromatography (RP-HPLC), which are suitable for the determination of cysteine coupled ADC. Hydrophobic interaction chromatography can separate the components with different Dar values according to the difference of hydrophobicity, and maintain the structural integrity of ADC molecules; Reversed phase high performance liquid chromatography needs to reduce the antibody to obtain light and heavy chains before analysis. It can be used to supplement and verify the results of hydrophobic interaction chromatography, and is suitable for mass spectrometry.
Mass spectrometry
Mass spectrometry is suitable for the determination of DAR value of lysine coupled ADC, including liquid chromatography tandem mass spectrometry and MALDI-TOF-MS. Lysine coupled ADC has strong heterogeneity, which increases the difficulty of mass spectrum analysis. Usually, additional pretreatment of ADC is required before determination, such as deglycosylation and removal of C-terminal lysine heterogeneity.
Cytotoxity assay of ADC
After the DAR of antibody is determined, the cytotoxicity experiment of ADC needs to be carried out. The cells are treated with different doses of ADC and their EC50 is analyzed. In the cytotoxicity experiment in vitro, the cells in the control group knocked out the target gene, so the antibody lost the role of localization and could not kill tumor cells, so it did not have the regularity of dose. However, from the treatment results of cells that have never been knocked out, they generally have better killing and EC50.
Cat No. | Products Name (INN Index) | INN Name | Previous Name | Target | Format | Order |
|---|---|---|---|---|---|---|
Pre-Made Telimomab Aritox Biosimilar, Whole Mab Adc, Anti-Cd5 Antibody: Anti-LEU1/T1 therapeutic antibody |
telimomab aritox |
NA |
CD5 |
ADC |
||
Pre-Made Telisotuzumab Vedotin Biosimilar, Whole Mab Adc, Anti-Met Antibody: Anti-AUTS9/DFNB97/HGFR/RCCP2/c-Met therapeutic antibody Drug Conjugate |
telisotuzumab vedotin |
NA |
MET |
Whole mAb ADC |
||
Pre-Made Tisotumab Vedotin Biosimilar, Whole Mab Adc, Anti-F3 Antibody: Anti-CD142/TF/TFA therapeutic antibody Drug Conjugate |
tisotumab vedotin |
NA |
F3 |
Whole mAb ADC |
||
Pre-Made Trastuzumab Deruxtecan Biosimilar, Whole Mab Adc, Anti-ERBB2/HER2 Antibody: Anti-CD340/neu/MLN 19/NEU/NGL/TKR1/VSCN2/c-ERB-2/c-ERB2 therapeutic antibody Drug Conjugate |
trastuzumab deruxtecan |
NA |
ERBB2 |
Whole mAb ADC |
||
Pre-Made Trastuzumab Duocarmazine Biosimilar, Whole Mab Adc, Anti-ERBB2/HER2 Antibody: Anti-CD340/neu/MLN 19/NEU/NGL/TKR1/VSCN2/c-ERB-2/c-ERB2 therapeutic antibody Drug Conjugate |
trastuzumab duocarmazine |
NA |
ERBB2 |
Whole mAb ADC |
||
Pre-Made Trastuzumab Emtansine Biosimilar, Whole Mab Adc, Anti-ERBB2/HER2 Antibody: Anti-CD340/neu/MLN 19/NEU/NGL/TKR1/VSCN2/c-ERB-2/c-ERB2 therapeutic antibody Drug Conjugate |
trastuzumab emtansine |
NA |
ERBB2 |
Whole mAb ADC |
||
Pre-Made Tusamitamab Ravtansine Biosimilar, Whole Mab Adc, Anti-CEACAM5/CD66e Antibody: Anti-CEA therapeutic antibody Drug Conjugate |
tusamitamab ravtansine |
NA |
CEACAM5 |
Whole mAb ADC |
||
Pre-Made Upifitamab Rilsodotin Biosimilar, Whole Mab Adc, Anti-Slc34A2 Antibody: Anti-NAPI-3B/NAPI-IIb/NPTIIb/PULAM therapeutic antibody Drug Conjugate |
upifitamab rilsodotin |
NA |
SLC34A2 |
Whole mAb ADC |
||
Pre-Made Vadastuximab Talirine Biosimilar, Whole Mab Adc, Anti-Cd33 Antibody: Anti-SIGLEC-3/SIGLEC3/p67 therapeutic antibody Drug Conjugate |
vadastuximab talirine |
NA |
CD33 |
Whole mAb ADC |
||
Pre-Made Vandortuzumab Vedotin Biosimilar, Whole Mab Adc, Anti-Steap1 Antibody: Anti-PRSS24/STEAP therapeutic antibody Drug Conjugate |
vandortuzumab vedotin |
NA |
STEAP1 |
Whole mAb ADC |
||
Pre-Made Vorsetuzumab Mafodotin Biosimilar, Whole Mab Adc, Anti-CD70/CD27-L Antibody: Anti-CD27LG/LPFS3/TNFSF7/TNLG8A therapeutic antibody Drug Conjugate |
vorsetuzumab mafodotin |
NA |
CD70 |
Whole mAb ADC |
||
Pre-Made Zilovertamab Vedotin Biosimilar, Whole Mab Adc, Anti-Ror1 Antibody: Anti-NTRKR1/dJ537F10.1 therapeutic antibody Drug Conjugate |
zilovertamab vedotin |
NA |
ROR1 |
Whole mAb ADC |
||
Pre-Made Zolimomab Aritox Biosimilar, Whole Mab Adc, Anti-Cd5 Antibody: Anti-LEU1/T1 therapeutic antibody |
zolimomab aritox |
NA |
CD5 |
ADC |
||
Pre-Made Actinium (225Ac) Lintuzumab Satetraxetan Biosimilar, Whole Mab Adc, Anti-Cd33 Antibody: Anti-SIGLEC-3/SIGLEC3/p67 therapeutic antibody Drug Conjugate |
actinium (225Ac) lintuzumab satetraxetan |
NA |
CD33 |
Whole mAb ADC |
||
Pre-Made Anetumab Corixetan Biosimilar, Whole Mab Adc, Anti-Msln Antibody: Anti-MPF/SMRP therapeutic antibody Drug Conjugate |
anetumab corixetan |
NA |
MSLN |
Whole mAb ADC |
||
Pre-Made Anetumab Ravtansine Biosimilar, Whole Mab Adc, Anti-Msln Antibody: Anti-MPF/SMRP therapeutic antibody Drug Conjugate |
anetumab ravtansine |
NA |
MSLN |
Whole mAb ADC |
||
Pre-Made Aprutumab Ixadotin Biosimilar, Whole Mab Adc, Anti-Fgfr2 Antibody: Anti-BBDS/BEK/BFR-1/CD332/CEK3/CFD1/ECT1/JWS/K-SAM/KGFR/TK14/TK25 therapeutic antibody Drug Conjugate |
aprutumab ixadotin |
NA |
FGFR2 |
Whole mAb ADC |
||
Pre-Made Azintuxizumab Vedotin Biosimilar, Whole Mab Adc, Anti-SLAMF7/CS1 Antibody: Anti-19A/CD319/CRACC therapeutic antibody Drug Conjugate |
azintuxizumab vedotin |
NA |
SLAMF7 |
Whole mAb ADC |
||
Pre-Made Belantamab Mafodotin Biosimilar, Whole Mab Adc, Anti-Tnfrsf17 Antibody: Anti-BCM/BCMA/CD269/TNFRSF13A therapeutic antibody Drug Conjugate |
belantamab mafodotin |
NA |
TNFRSF17 |
Whole mAb ADC |
||
Pre-Made Brentuximab Vedotin Biosimilar, Whole Mab Adc, Anti-Tnfrsf8 Antibody: Anti-CD30/D1S166E/Ki-1 therapeutic antibody Drug Conjugate |
brentuximab vedotin |
NA |
TNFRSF8 |
Whole mAb ADC |
||
Pre-Made Camidanlumab Tesirine Biosimilar, Whole Mab Adc, Anti-Il2Ra Antibody: Anti-CD25/IDDM10/IL2R/IMD41/TCGFR/p55 therapeutic antibody Drug Conjugate |
camidanlumab tesirine |
NA |
IL2RA |
Whole mAb ADC |
||
Pre-Made Cantuzumab Mertansine Biosimilar, Whole Mab Adc, Anti-Muc1 Antibody: Anti-ADMCKD/ADMCKD1/ADTKD2/CA 15-3/CD227/Ca15-3/EMA/H23AG/KL-6/MAM6/MCD/MCKD/MCKD1/SEC/X/ZD/PEM/PEMT/PUM therapeutic anti |
cantuzumab mertansine |
NA |
MUC1 |
Whole mAb ADC |
||
Pre-Made Cantuzumab Ravtansine Biosimilar, Whole Mab Adc, Anti-Muc1 Antibody: Anti-ADMCKD/ADMCKD1/ADTKD2/CA 15-3/CD227/Ca15-3/EMA/H23AG/KL-6/MAM6/MCD/MCKD/MCKD1/SEC/X/ZD/PEM/PEMT/PUM therapeutic anti |
cantuzumab ravtansine |
NA |
MUC1 |
Whole mAb ADC |
||
Pre-Made Cetuximab Sarotalocan Biosimilar, Whole Mab Adc, Anti-Egfr Antibody: Anti-ERBB/ERBB1/ERRP/HER1/NISBD2/PIG61/mENA therapeutic antibody Drug Conjugate |
cetuximab sarotalocan |
NA |
EGFR |
Whole mAb ADC |
||
Pre-Made Clivatuzumab Tetraxetan Biosimilar, Whole Mab Adc, Anti-Muc1 Antibody: Anti-ADMCKD/ADMCKD1/ADTKD2/CA 15-3/CD227/Ca15-3/EMA/H23AG/KL-6/MAM6/MCD/MCKD/MCKD1/SEC/X/ZD/PEM/PEMT/PUM therapeutic an |
clivatuzumab tetraxetan |
NA |
MUC1 |
Whole mAb ADC |
||
Pre-Made Cofetuzumab Pelidotin Biosimilar, Whole Mab Adc, Anti-Ptk7 Antibody: Anti-CCK-4/CCK4 therapeutic antibody Drug Conjugate |
cofetuzumab pelidotin |
NA |
PTK7 |
Whole mAb ADC |
||
Pre-Made Coltuximab Ravtansine Biosimilar, Whole Mab Adc, Anti-Cd19 Antibody: Anti-B4/CVID3 therapeutic antibody Drug Conjugate |
coltuximab ravtansine |
NA |
CD19 |
Whole mAb ADC |
||
Pre-Made Dafsolimab Setaritox Biosimilar, Whole Mab Adc, Anti-Cd3E Antibody: Anti-CD3epsilon/IMD18/T3E/TCRE therapeutic antibody Drug Conjugate |
dafsolimab setaritox |
NA |
CD3E |
Whole mAb ADC |
||
Pre-Made Datopotamab Deruxtecan Biosimilar, Whole Mab Adc, Anti-Tacstd2 Antibody: Anti-EGP-1/EGP1/GA733-1/GA7331/GP50/M1S1/TROP2 therapeutic antibody Drug Conjugate |
datopotamab deruxtecan |
NA |
TACSTD2 |
Whole mAb ADC |
||
Pre-Made Denintuzumab Mafodotin Biosimilar, Whole Mab Adc, Anti-Cd19 Antibody: Anti-B4/CVID3 therapeutic antibody Drug Conjugate |
denintuzumab mafodotin |
NA |
CD19 |
Whole mAb ADC |
||
Pre-Made Depatuxizumab Mafodotin Biosimilar, Whole Mab Adc, Anti-Egfr Antibody: Anti-ERBB/ERBB1/ERRP/HER1/NISBD2/PIG61/mENA therapeutic antibody Drug Conjugate |
depatuxizumab mafodotin |
NA |
EGFR |
Whole mAb ADC |
||
Pre-Made Disitamab Vedotin Biosimilar, Whole Mab Adc, Anti-ERBB2/HER2 Antibody: Anti-CD340/neu/MLN 19/NEU/NGL/TKR1/VSCN2/c-ERB-2/c-ERB2 therapeutic antibody Drug Conjugate |
disitamab vedotin |
NA |
ERBB2 |
Whole mAb ADC |
||
Pre-Made Dorlimomab Aritox Biosimilar, Whole Mab Adc: Anti-40S Ribosomal Protein S18 therapeutic antibody |
dorlimomab aritox |
NA |
40S ribosomal protein S18 |
ADC |
||
Pre-Made Enapotamab Vedotin Biosimilar, Whole Mab Adc, Anti-Axl Antibody: Anti-ARK/JTK11/Tyro7/UFO therapeutic antibody Drug Conjugate |
enapotamab vedotin |
NA |
AXL |
Whole mAb ADC |
||
Pre-Made Enfortumab Vedotin Biosimilar, Whole Mab Adc, Anti-PVRL4/NECTIN4 Antibody: Anti-EDSS1/LNIR/PRR4/nectin-4 therapeutic antibody Drug Conjugate |
enfortumab vedotin |
NA |
PVRL4 |
Whole mAb ADC |
||
Pre-Made Farletuzumab Ecteribulin Biosimilar, Whole Mab Adc, Anti-Folr1 Antibody: Anti-FBP/FOLR/FRalpha/NCFTD therapeutic antibody Drug Conjugate |
farletuzumab ecteribulin |
NA |
FOLR1 |
Whole mAb ADC |
||
Pre-Made Gemtuzumab Ozogamicin Biosimilar, Whole Mab Adc, Anti-Cd33 Antibody: Anti-SIGLEC-3/SIGLEC3/p67 therapeutic antibody Drug Conjugate |
gemtuzumab ozogamicin |
NA |
CD33 |
Whole mAb ADC |
||
Pre-Made Glembatumumab Vedotin Biosimilar, Whole Mab Adc, Anti-Gpnmb Antibody: Anti-HGFIN/NMB/PLCA3 therapeutic antibody Drug Conjugate |
glembatumumab vedotin |
NA |
GPNMB |
Whole mAb ADC |
||
Pre-Made Grisnilimab Setaritox Biosimilar, Whole Mab Adc, Anti-Cd7 Antibody: Anti-GP40/LEU-9/TP41/Tp40 therapeutic antibody Drug Conjugate |
grisnilimab setaritox |
NA |
CD7 |
Whole mAb ADC |
||
Pre-Made Iladatuzumab Vedotin Biosimilar, Whole Mab Adc, Anti-Cd79B Antibody: Anti-AGM6/B29/IGB therapeutic antibody Drug Conjugate |
iladatuzumab vedotin |
NA |
CD79B |
Whole mAb ADC |
||
Pre-Made Indatuximab Ravtansine Biosimilar, Whole Mab Adc, Anti-Sdc1 Antibody: Anti-CD138/SDC/SYND1/syndecan therapeutic antibody Drug Conjugate |
indatuximab ravtansine |
NA |
SDC1 |
Whole mAb ADC |
||
Pre-Made Indusatumab Vedotin Biosimilar, Whole Mab Adc, Anti-Gucy2C Antibody: Anti-DIAR6/GC-C/GUC2C/MECILIL/STAR therapeutic antibody Drug Conjugate |
indusatumab vedotin |
NA |
GUCY2C |
Whole mAb ADC |
||
Pre-Made Inotuzumab Ozogamicin Biosimilar, Whole Mab Adc, Anti-Cd22 Antibody: Anti-SIGLEC-2/SIGLEC2 therapeutic antibody Drug Conjugate |
inotuzumab ozogamicin |
NA |
CD22 |
Whole mAb ADC |
||
Pre-Made Labetuzumab Govitecan Biosimilar, Whole Mab Adc, Anti-CEACAM5/CD66e Antibody: Anti-CEA therapeutic antibody Drug Conjugate |
labetuzumab govitecan |
NA |
CEACAM5 |
Whole mAb ADC |
||
Pre-Made Ladiratuzumab Vedotin Biosimilar, Whole Mab Adc, Anti-Slc39A6 Antibody: Anti-LIV-1/LIV1/ZIP6 therapeutic antibody Drug Conjugate |
ladiratuzumab vedotin |
NA |
SLC39A6 |
Whole mAb ADC |
||
Pre-Made Laprituximab Emtansine Biosimilar, Whole Mab Adc, Anti-Egfr Antibody: Anti-ERBB/ERBB1/ERRP/HER1/NISBD2/PIG61/mENA therapeutic antibody Drug Conjugate |
laprituximab emtansine |
NA |
EGFR |
Whole mAb ADC |
||
Pre-Made Lifastuzumab Vedotin Biosimilar, Whole Mab Adc, Anti-Slc34A2 Antibody: Anti-NAPI-3B/NAPI-IIb/NPTIIb/PULAM therapeutic antibody Drug Conjugate |
lifastuzumab vedotin |
NA |
SLC34A2 |
Whole mAb ADC |
||
Pre-Made Loncastuximab Tesirine Biosimilar, Whole Mab Adc, Anti-Cd19 Antibody: Anti-B4/CVID3 therapeutic antibody Drug Conjugate |
loncastuximab tesirine |
NA |
CD19 |
Whole mAb ADC |
||
Pre-Made Lonigutamab Ugodotin Biosimilar, Whole Mab Adc, Anti-Igf1R Antibody: Anti-CD221/IGFIR/IGFR/JTK13 therapeutic antibody Drug Conjugate |
lonigutamab ugodotin |
NA |
IGF1R |
Whole mAb ADC |
||
Pre-Made Lorvotuzumab Mertansine Biosimilar, Whole Mab Adc, Anti-Ncam1 Antibody: Anti-CD56/MSK39/NCAM therapeutic antibody Drug Conjugate |
lorvotuzumab mertansine |
NA |
NCAM1 |
Whole mAb ADC |
View the Knowledge base of Antibody-drug Conjugate (ADC):
– What is antibody-drug conjugate (ADC)?
– Antibody-drug conjugate (ADC) in clinical application (Approved/BLA, phaseI/II/III)
– Main elements of antibody-drug conjugate (ADC)： Antibodies and their targets
– Main elements of antibody-drug conjugate (ADC)：Linker (cleavable/non-cleavable, structure and mechanism)
– Main elements of antibody-drug conjugate (ADC)：Toxins/Payloads (Classification and function)
– Toxins/Payloads (Classification and function) of Microtubule destroying drug
– Toxins/Payloads (Classification and function) of DNA damage drugs
– Toxins/Payloads (Classification and function) of Innovative drugs
– Biological coupling technology Chemical based specific in situ antibody modification
– Endogenous coupling of amino acids and Disulfide re bridging strategy
– Glycan coupling
– Site specific biological coupling of engineered antibodies and Enzymatic method
– Biological coupling with engineered unnatural amino acids
– Review for ADC production, quality control and functional assay
– Product data of ADC
