CREATE Bio Example: Antibody Agent Profile Table

The following table represents example categories to consider in describing your current results/status and desired results at the end of the funding period.

 

Category

Parameters

Structure/Identity

Class and sub-class

Light Chain Composition

Amino acid (AA) sequence

Carbohydrate content

AA-sequence confirmed by peptide mapping

3D structure

Epitope mapping

In vitro  activity

Target binding: affinity/saturation

Bioactivity/potency

Stimulation of biological cascade

Tissue Selectivity

Selectivity/off-target effect to related target

In vivo activity (such as target engagement/proximal downstream effect or efficacy)  Indicate dose and route of administration

Concentrations of testing agent in the serum and target tissue

Brain penetration

Serum half-life, AUC or other pharmacokinetic properties

Optimize Dose Selection and Schedule

ED50, Minimal effective dose, and Optimal effective dose

Treatment duration optimization

Treatment window optimization

Interactions with standard of care

Selectivity/off-target effect in vivo

 Safety

Tolerability

Antibodies to product

Tumorigenesis

Assess host immune response

Tissue Cross-Reactivity

Local reactogenicity

Cardiovascular, respiratory, renal and CNS safety pharmacology studies if any

CMC

Master/Working Virus Bank Status

Process development status

Analytical Assays for release testing with specifications

Scale-up feasibility

Formulation needs/development

Stability Analysis

Potency assays (in vitro/in vivo)

Delivery devices

GLP analytical method development/validation

Potency assays, assays for purity, pharmacokinetics and pharmacodynamics etc

Interactions with regulatory agencies

Pre-IND

Patent protection?