Scope

In scope

Out of scope

>Molecules: standard and non-standard mAbs (i.e. bi-/multi-specific's, ADCs, IgG/Fc fusions).

>Data: Chemical & structural stability, Aggregation, Toxicity, PK and Immunogenicity.

>Assays: early selection (high-throughput), detailed profiling (bespoke, low-throughput) and endpoint (pre-candidate nomination).

>Data: Manufacturability (expression yields).

Basecase scenario

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')

	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	<standard mAbs, bi-multi specifics, ADC's, IgG/Fc fusions>	<standard mAbs, bi-multi specifics, ADC's, IgG/Fc fusions>	<standard mAbs, bi-multi specifics, ADC's, IgG/Fc fusions>
Sequence	<Yes/No>	<Yes/No>	<Yes/No>
3D structure	<Yes/No (homology model)>	<Yes/No (homology model)>	<Yes/No (homology model)>
Structure descriptors	How are we going to quantify this?	<list which>	<list which>

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 <definition>	cIEF e.g. NanoPro
Structural stability <definition>	DSF, HP-SEC (post-stress)
(self) Aggregation <definition>	AC-SINS, HP-SEC column interaction
Toxicity <definition>
Immunogenicity <definition>
Cyno PK (non-specific Clearance) <definition>	Baculovirus particles, HEK or CHO cells, yeast extracts, Heparin, etc.
Human PK (non-specific Clearance) <definition>	As above