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last update : 2017-06-14
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Quality Assistance, le support essentiel des grands de la pharma (L'Echo)
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Antibody Drug Conjugates

Facing the most critical challenges of ADCs development:

To find reliable partners able to provide chemical and biological expertise in the same location

With a full analytical package for Biologics, Quality Assistance provides scientific and technical support to biopharmaceutical companies developing Antibody-Drug Conjugates.

Thanks to our combined experience with small molecule cytotoxics and monoclonal antibodies, we can provide full analytical support for your projects. We offer a wide range of services for all payload categories (maytansine derivatives, auristatins, etc.) and all conjugation strategies (lysine, cysteine, site-specific).

Throughout non-clinical and clinical development, our scientific team provides you with customised solutions in terms of analytical protocols and innovative technologies to help you move your product towards registration.

Based on over 30 years’ expertise in NCEs and Cytotoxics and over 15 in Biologics, our capabilities in this area are summarized in the following table :

MCB & WCB
Characterisation FACS / ICC (Immunocytochemistry)
Microbiology Bioburden /  Sterility (filtration, direct inoculation) / Mycoplasma (QPCR)
Plasmid copy number Q-PCR
General Quality
Appearance Properties after reconstitution
pH / Osmolarity (if liquid) Zeta potential
Water content / residual moisture (if lyophilised) KF / Coulometer
Particulate matter Optical microscopy / Light obscuration / Imaging Particle Analysis
Identity
Intact protein molecular weight Mass spectrometry (ESI-QTOF, MALDI-TOF, ESI-IonTrap) / SDS-PAGE / Bioanalyzer
Isoforms Mass spectrometry (ESI-QTOF, MALDI-TOF, ESI-IonTrap) / IEF / (i)cIEF / (U)HPLC (IEX, RP, SEC, HIC) / 2-D gel / Peptide mapping
Peptide mapping UPLC (UV, QTOF, IonTrap) / MALDI-TOF
Immunological identification ELISA / ECL (MSD) / Luminex / Western blotting / RID / Biacore
Identification of linked cytotoxic payload UPLC (UV/MS)
N- and C-terminal sequencing ESI-IonTrap (ETD) / MALDI-TOF (ISD)
Quantity
Protein quantity BCA / Lowry / Bradford / UV / (U)HPLC (UV)
Absolute protein content determination Amino Acid Analysis (AAA) by UPLC (UV or FLUO, ACCQ-TAG Ultra) / ICP/MS (S, isotope dilution)
Determination of extinction coefficient UV + ICP/MS (S, isotope dilution) or AAA (UPLC-UV or FLUO)
Drug Antibody Ratio (DAR) (U)HPLC (UV) / UV/visible / HIC / Mass spectrometry (ESI-QTOF, MALDI-TOF, ESI-IonTrap) / SEC-HPLC (UV, RI, MALS) / A4F (UV, RI, MALS) / icIEF
Detection of free cytotoxic compound (U)HPLC (UV) / UV
Purity & Integrity
Mass distribution profile Mass spectrometry (ESI-QTOF, MALDI-TOF, ESI-IonTrap)
Structural integrity Circular Dichroism (CD)
Isoforms IEF / (i)cIEF / (U)HPLC (IEX, RP, SEC, HIC) / 2-D gel / Peptide mapping / Mass Spectrometry
Aggregation, fragments and particle size distribution SEC-(U)HPLC (UV, RI, MALS) / A4F/HF5 (UV, RI, MALS) / CE / DLS / (SDS-)PAGE / Bioanalyzer / Imaging Particle Analysis
Glycosylation patterns UPLC (FLUO, QTOF, IonTrap) / MALDI-TOF / CE (LIF) / GC (MS)
Disulfide bridges SDS-PAGE / Peptide mapping / Bioanalyzer
Free thiols Fluoresence (NPM) / UV (Ellman, DTNB)
Degradation patterns (oxidation, deamidation, lys-term truncation, etc.) IEX / RP-(U)HPLC / SEC-(U)HPLC / (SDS-)PAGE / (U)HPLC (MS) / CE (icIEF, CE-SDS) / Bioanalyzer / 2D-Gel
Potency
Immunoassays / Cytotoxicitycell ELISA, ECL (MSD) / Luminex / Cell-based assays / FACS / Biacore
Process-related Impurities
Residual solvents HS-GC (FID, MS, ECD)
Residual proteins (incl. HCP, protein A, purification Ab) ELISA / ECL (MSD) / Luminex / UPLC (MS/MS) / Western blotting / 2D-Gel / 2D-DIGE
Buffer components (incl. BSA, Tween, ß-OG, Antibiotics) ELISA / ECL (MSD) / Luminex / Colorimetry / (U)HPLC (UV, MS, RI, ELSD, CAD)
Antifoam agents (PPG, PEG, silicone oil) ICP (MS, OES) / (U)HPLC (ELSD, CAD)
Residual DNA Q-PCR / PicoGreen / Threshold (to be discussed)
Elemental impurities ICP(OES, MS)
Microbiology Bioburden / Sterility (filtration, direct inoculation)
Endotoxins LAL (kinetic, end point)
Packaging
Leachables and extractables GC (FID, ECD, MS) / ICP (OES, MS) / (U)HPLC (UV, ELSD, CAD)
Container Closure System Integrity Bubbling / Dye ingress / Microbial ingress
Cytotoxicity / Biological reactivity Cell-based assays / USP<87>
Pharmacokinetics & Toxicokinetics / Biomarkers / Immunogenicity
 Drug / Metabolites ELISA / ECL (MSD) / Luminex / UPLC (MS/MS) / ICP (OES, MS) / ESI-QTOF
Biomarkers ELISA / ECL (MSD) / Luminex / UPLC (MS/MS)
Vehicles / Buffers ELISA / ECL (MSD) / Luminex / (U)HPLC (UV, RI, DAD, FLUO, ELSD, CAD, MS) / ICP (OES, MS)
Immunogenicity ELISA / ECL (MSD) / Luminex / Cell-based assays (neutralization) / Biacore

 

Events

World ADC
21-22 February 2017
Belrin, Germany

 

 

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Resources

Presentation

Webinar
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Advances in Mass Spectrometry for the Characterisation and Bioanalysof ADCs By Dr Arnaud DELOBEL, R&D Director

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Mass Spectrometry toolkit for the characterisation of ADCs By Dr Arnaud DELOBEL, R&D Director

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News

News

Fast and accurate absolute-quantification of proteins and antibodies using Isotope Dilution-Triple Quadrupole ICP-MS

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2D-LC-MS for the Analysis of Monoclonal Antibodies and Antibody-Drug Conjugates in a Regulated Environment

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News

News

 

State-of-the-Art MS Methods for Structural Assessment of mAbs and ADCs:
From the Research Lab to Routine Characterization

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