FOUNDING PARTNER PROGRAM / Exploring early developability studies Scope a pilot
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EXPERIMENTAL CAPABILITIES

A complete analytical view.
Built around your molecule.

Customize a program from expression and binding through aggregation, stability and fit-for-purpose sample readiness. Every measurement serves a specific research decision.

EXPRESSIONSPR / BLISEC / DLSnanoDSFCANDIDATE DOSSIER
01

Expression, identity & purity

Establish whether the candidate can be produced and analytically identified at the quality needed for the planned characterization.

Method / servicePrimary outputApplicabilityScientific considerations
Sequence assessmentSequence, predicted charge/mass, liability flagsAll supported modalitiesIn silico prioritization; does not replace experimental characterization
Construct strategy & synthesisConstruct description, tags and expression designVHH, scFv, Fab, IgG, proteinsFinal scope depends on intellectual property and expression feasibility
Small-scale expression & purificationYield, recovery, molecular mass and sample inventoryModality-specific platformsMammalian expression may be needed for appropriate PTMs
SEC-HPLC / SEC-UPLCMonomer, high-molecular-weight and fragment fractionsSoluble proteinsDetection and interpretation depend on column, buffer and concentration
CE-SDS / SDS-PAGESize, purity, subunit integrity as applicableAntibody and protein formatsReduced/non-reduced format selected case-by-case
Intact mass / peptide mappingIdentity, heterogeneity and selected liabilitiesOptional / extendedOrthogonal characterization; not universally required
02

Binding kinetics & selectivity

Go beyond a binary hit by quantifying relevant binding behavior and prioritizing specificity risk.

Method / servicePrimary outputApplicabilityScientific considerations
BLI/SPR screeningBinding response and preliminary rankSmall binder librariesBinary detection is not necessarily a reliable quantitative Kd
Full SPR/BLI kineticsk_on, k_off, Kd, curves and fit qualityPurified protein and suitable antigenLigand configuration, avidity and mass transport need review
Competition / epitope binningCompetition relationships and candidate groupingSelected antibody programsAssay feasibility and target reagent requirements vary
Cross-species / cross-reactivitySpecies target binding and selected off-target panelsIn vivo planningRequires appropriate reference proteins and context
Cell-surface binding / functionTarget engagement or functional readoutSelected programsOptional, needs validated cells and assay-specific controls
03

Stability, aggregation & interactions

Understand early physical stability and solution behavior before scaling into the next study.

Method / servicePrimary outputApplicabilityScientific considerations
nanoDSF / DSFTm, transition traces, Tonset where robustCompatible protein and bufferInterpretation can be format-dependent
DLSHydrodynamic size / polydispersitySolution-formulated proteinsConcentration and scattering artifacts require review
SEC stress assessmentMonomer change under defined stressesEarly stability programsTime / temperature / agitation must be specified
HIC / hydrophobicityHydrophobicity-related interaction profileOptionalScreening proxy, not a direct PK prediction
AC-SINS / self-interactionColloidal / self-association risk flagsFormat-dependentMay need orthogonal confirmation
Short-term stabilityChanges in potency / monomer / purityStudy-specificStorage and handling profile agreed with sponsor
04

Study material & handoff

Prepare material with explicit requirements for the next research study, without implying regulatory grade.

Method / servicePrimary outputApplicabilityScientific considerations
Research protein preparationAvailable inventory, formulation and concentrationProject-specificSpecification must be agreed in advance
Endotoxin / bioburden where indicatedSample QC versus animal-protocol criteriaIn vivo preparationAcceptance limits depend on dose, route and study
Storage / shipping guidanceHandling notes and tested short-term stabilityWhere relevantShipping is not itself evidence of product stability
Integrated candidate dossierRaw data, methods, interpretation, risk matrixAll full programsDoes not replace nonclinical regulatory package