Helping You Navigate the Path

to BLA and Beyond With Confidence 

Complex therapeutic molecules, proteins, and biologics demand an equally sophisticated approach to testing. For developers navigating regulatory milestones or preparing for a sale ahead of a Biologics License Application (BLA), knowing more about your molecule earlier can make all the difference.

The Eurofins BioPharma Product Testing (BPT) network of laboratories provides comprehensive, cGMP-compliant physico-chemical characterisation for large molecules, including monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), fusion proteins, and biosimilars.

Our detailed analytical testing helps you gain a deeper understanding of the identity, structure, purity, and stability of your therapeutic candidates, supporting informed decisions at every stage of development.

By combining leading instrumentation with expert interpretation, our scientists deliver not just results, but insight that highlights the risks and potential formulation challenges that could impact downstream development or regulatory acceptance.

Demonstrating a well-characterised product can significantly enhance its appeal and valuation to potential partners or acquirers. Eurofins BPT is uniquely positioned to support smaller biotech companies who may seek to license or sell early-stage molecules.  

With access to advanced analytical platforms and proprietary methods, dedicated project management, and scalable support tailored to your molecule and development timeline, partner with Eurofins BPT to unravel the complexities of your large molecule therapies. 

Characterization Testing Capabilities

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Physico-chemical properties

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Intact Molecular weight (ESI-MS, LC-MS, SEC-UV, SEC-MALS, MALDI-TOF MS)

Intact proteins, subunits (reduced form), and domains (IdeS® enzyme)

Glycosylated and deglycosylated proteins

Identification of isoforms and glycoforms

ADCs Drug to Antibody Ratio (DAR) calculation

Proteins and pegylated proteins

Amino acid analysis for concentration determination and Extinction Coefficient Estimation

Protein concentration (Amino Acid Analysis, SoloVPE® system, A280)

Thermal unfolding (Nano-DSC® instrument)

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Primary structures and Post-Translational Modifications

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Peptide mapping including:

Confirmation of amino acid sequence, Sequence coverage, Post translational Modifications evaluation, Disulfide bond mapping

Free Thiol Analysis (Ellman’s)

Glycosylation analysis

Monosaccharide quantitative analysis, Sialic acid quantitative analysis, N- and O-glycan chromatographic profiling, N- and O-glycan mass spectrometry structural elucidation

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High Order Structures: Secondary and Tertiary

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Circular Dichroism (Near and far UV)

FTIR (ATR and Transmission)

Intrinsic and Extrinsic Fluorescence

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Aggregation

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SEC-UV, SEC-RI, SEC-MALS

SV-AUC

DLS (incl. Zeta Potential evaluation)

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Particle analysis

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DLS (incl. Zeta Potential evaluation)

MFI

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Product-related impurity evaluation

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Charges variants by HPLC techniques

Size variants (CE-SDS, CE-LIF, SDS-PAGE, Native-PAGE, SEC-HPLC, SEC-MALS)

Hydrophobic profiles by RP and HIC chromatography

Residual testing

Residual HCP identification and selective quantitation by mass spectrometry

Gel-band identification by proteomics techniques and databases interrogation

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Product-related impurity identification

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Fraction collection and identification of unknown peaks using peptide mapping strategy and NanoLC-MS/MS (High Resolution Mass spectrometry instrument)