DEVELOPABILITY ASSESSMENT

Developability AssessmentDevelopability Assessment

As biologics discovery platform technologies mature, most targets now yield multiple candidate molecules with the desired functional activity. Zencore's molecular developability assessment platform provides evaluation services for post-translational modifications, molecular stability and physicochemical properties, helping clients rapidly narrow the pool of candidates early in development, select the candidates with the best activity and greatest developability, reduce downstream development risk and improve the odds of project success.

Post-translational modificationsProtein physicochemical propertiesMolecular stability6 stress conditions
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4 types
Mass spectrometry confirmation of PTMs (isomerization / deamidation / oxidation / glycosylation)
5 types
Physicochemical characterization methods (mass spectrometry / SEC-HPLC / CE-SDS / CEX-iCIEF / DSF)
6 items
Stability assessment under stress conditions
Why Developability

Why perform developability assessmentPlatform Value

Introducing systematic developability assessment early in drug development, moving molecule selection from "activity first" to "developability first."

rapidly narrowing the screening pool

When multiple candidates meet activity targets for the same target, systematic evaluation quickly focuses on the superior molecule, reducing wasted investment.

Reducing downstream development risk

Surfacing developability risks such as post-translational modifications, aggregation, fragmentation and instability early, avoiding costly rework after entering the clinic.

Accelerating IND go/no-go decisions

Delivering a developability ranking and comprehensive assessment report for candidate molecules, supporting rapid identification of the most active and most developable molecule.

Platform Services

Platform developability assessment servicesAssessment Capabilities

From sequence-level risk identification to comprehensive molecular characterization and stress challenges, three layers build a complete developability profile.

Sequence - experiment

Post-translational modificationsPost-translational Modifications

  • Through systematic sequence analysis, locating potential post-translational modification sites that may affect developability (hotspots
  • Confirmation and evaluation of potential sites through experimental approaches such as mass spectrometry
  • Coverageisomerization, deamidation, oxidation, glycosylationand other common modification types
5 methods

Protein physicochemical propertiesPhysicochemical Properties

  • adoptTransient transfectionmethods to estimate protein titer
  • Mass spectrometryAnalyzing molecular integrity and common modifications
  • SEC-HPLC and CE-SDS methods examine protein size heterogeneity
  • CEX or iCIEF methods analyze isoelectric point and charge heterogeneity
  • DSF methods to assess thermal stability
6 conditions

Molecular stabilityMolecular Stability

  • Accelerated stress challenge studies under multiple stress conditions, systematically assessing molecular stability boundaries
40 C accelerated thermal stabilityPhotostabilityShaking stabilityAcid/base stabilityOxidation stabilityFreeze-thaw stability
Workflow

Developability assessment workflowAssessment Workflow

A standardized six-step assessment pathway, from sequence analysis to a comprehensive report, providing a complete basis for candidate selection.

1STEP 01

Sequence analysis

Systematically analyzing candidate molecule sequences to locate potential post-translational modification hotspot sites that may affect developability.

2STEP 02

Modification site confirmation

Confirming and evaluating potential sites of isomerization, deamidation, oxidation and glycosylation using experimental approaches such as mass spectrometry.

3STEP 03

Expression and sample preparation

Estimating protein titer via transient transfection to rapidly prepare samples for comprehensive characterization.

4STEP 04

Physicochemical characterization

mass spectrometry, SEC-HPLC, CE-SDS, CEX/iCIEF and DSF provide multi-dimensional analysis of molecular integrity, size and charge heterogeneity, and thermal stability.

5STEP 05

Stress stability assessment

Molecular stability is examined under 6 stress conditions: 40 C accelerated, light exposure, shaking, acid/base, oxidation and freeze-thaw.

6STEP 06

Comprehensive assessment report

Aggregating data across all dimensions to deliver a candidate developability assessment report and screening recommendations that support go/no-go decisions.

Let the best molecule win at the starting line

Struggling to choose among multiple candidates? Zencore's developability assessment platform helps you identify the most developable molecule early.

Inquire about developability assessment