This table captures the minimum information required to meet some of our objectives (see 'objectives') and for the database to be of value (see 'value proposition')

Colour coding: Jain et el (2017), Abvance Biotech, GSK, Lilly, MedImmune, Novartis

DEVELOPABILITY ASSESSMENT
Candidate Screening (post-Target Validation) to Lead Candidate Selection (pre-Pre Clinical)

EARLY SELECTION

FINAL PROFILING

ENDPOINT DATA

MOLECULES

From patented, published or 'dead' discovery campaigns. Need molecules with 'interesting' or 'poor' properties

Typical throughput number

x (# organisations), x (# projects)

~50

~5

~1+1

Type

Sequence

3D structure

Structure descriptors

How are we going to quantify this?

ASSAYS

Select assays based on: whether a peer-reviewed publication exists of its use for Ab characterisation, amenable to characterising 100s of Abs, consumes <1mg material, provides decision-making data for the below developability risk factors (ideally part of TPP at Lead Identification)

Chemical stability

cIEF e.g. NanoPro

in silico predictions

Antigen binding by biacore (active concentration & kinetics) - pre/post stress

cIEF

LC-MS

CE-SDS

LC-MS, CZE, CE-SDS

Mass spec (glycan analysis, intact mass, peptide mapping)

cIEF

CGE (capillary gel electrophoresis)

reverse phase HPLC

Antigen binding by biacore (active concentration & kinetics)

(ad hoc testing as needed includes CD, DSC, bioanalyser NGHC, ion exchange chromatography)

LC-MS, CZE, CE-SDS - pre/post stress

Antigen binding by biacore - pre/post serum incubation

Structural stability

Tm, SEC (AS)

DSF, HP-SEC (post-stress)

DSF, aSEC

DSF, aSEC, MALLS

aSEC, DLS, AUC

DSC

AUC

DSC, aSEC

aSEC, DLS, AUC

aSEC

aSEC, turbidity – pre/post incubation in different formulations

(self) Aggregation

AC-SINS, CSI-BLI, PSR binding, BVP, CIC, ELISA, SGAC-SINS, HIC, SMAC

AC-SINS, HP-SEC column interaction

HIC, aSEC

HIC, aSEC, MALLS

HIC, aSEC

PEG-induced precipitation

K-Diff

K-Diff by DLS, aSEC

aSEC, turbidity – pre/post incubation in different formulations (rheometry)

Immunogenicity

in silico predictions

(MAPPS assay)

Cyno PK (non-specific Clearance)

Baculovirus particles, HEK or CHO cells, yeast extracts, Heparin, etc.

HepSO4 chromatogaphy,

FcRN interaction (chromatography or SPR)

FcRN interaction by SPR

ProteinChip to evaluate potential for unspecific interactions

Human PK (non-specific Clearance)

As above

FcRN interaction (chromatography or SPR)

FcRN interaction by SPR

Scope

Basecase scenario

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