Biosciences
Offspring
Engineered for the Drug Development Lifecycle
The Right Data for the Right Decision
Aligned with the AstraZeneca 5R Framework
We don't offer a "one-size-fits-all" menu. Our services are modular, designed to inject Decisive Insights at critical Go/No-Go decision points. Whether you are validating a novel target or filtering lead candidates, we provide the evidence you need to proceed with confidence.
The Logic of Success:
Adapting the 5R Framework for Preclinical Reality
Clinical success starts with preclinical rigor.
We bridge the translational gap by proving the biological fundamentals that determine Phase II success: the Right Target (validated in human disease tissue), the Right Drug (with appropriate target binding properties as demonstrated in relevant human tissues), the Right Mechanism (demonstrated tissue peneration, target engagement and quantified pathway modulation), Right Safety (non‑GLP tissue cross‑reactivity screening to identify potential off‑target risks), and the Right Patient (stratified by molecular phenotype). Our five service modules adapt AstraZeneca’s 5R framework and align with Pfizer’s SOCA principles to create actionable, tissue‑based validation workflows - transforming the subjective microscope into objective, statistically powered decision data.
Module 1: Drug Target Validation
Confirm the Target - Validate the Context
[Right Target]
Before you invest millions in antibody generation, you need to know if your target is expressed in the relevant human disease tissue. Public databases (TCGA/GTEx) are not enough - they lack spatial context.
Human Tissue First: We map and quantify mRNA (ISH) and Protein (IHC) expression in normal vs. diseased human tissues.
Indication Expansion: We screen your target across multiple tumor types or disease indications to identify new therapeutic opportunities.
The Output: High-resolution heatmaps demonstrating that your target is present, accessible, and relevant.
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Module 2: Antibody Selection & Optimization
Don’t Just Select Binders.
Select Winners.
[Right Drug]
High affinity binding in an ELISA or SPR does not guarantee performance in complex tissue. This is where the pharmaceutical "Valley of Death" begins. We screen your hybridoma hits or phage display candidates directly on human tissue to select the clone with the optimal binding profile.
High-Volume Screening: We act as the biological filter for your Design-Make-Test cycles, screening campaigns of up to 100 antibody candidates directly on tissue to identify the best binders early.
Competitive Benchmarking: Is your candidate "Best-in-Class"? We perform side-by-side IHC comparisons of your molecule against competitor antibodies or clinical standards on the same tissue block.
Translational Fitness: We assess epitope stability under various fixation conditions to ensure your lead is robust enough for clinical diagnostics.
Module 3: Efficacy & Mechanism of Action
Quantifying the Biology of Response
[Right Mechanism]
When you run your in vivo efficacy studies, don't leave data on the table. We analyze tissues from your animal models to prove why the drug worked (or didn't).
Visualizing Target Engagement (isPLA): We use in situ Proximity Ligation Assays to prove your antibody has physically accessed and bound its target receptor in the tissue.
PD Biomarker Analysis: Quantitative assessment of downstream effects (e.g., phosphorylation, immune cell recruitment, apoptosis).
The Result: A clear Pharmacodynamic (PD) readout that correlates with efficacy, essential for your Investigator's Brochure (IB).
Module 4: Pre-TCR
(Tissue Cross-Reactivity)
The Agile Insurance Policy
Fail fast here, so you don't fail expensively later
[Right Safety]
Regulatory GLP Tissue Cross-Reactivity (TCR) studies are slow, rigid, and cost upwards of $200k. Don’t send a candidate to the full GLP TCR study until you know it’s clean.
The "Strategic Filter": We offer an ISO 17025-aligned Pre-TCR service. We screen your lead candidate against critical human organs (eg. Heart, Brain, Liver, Kidney) on multi-organ Tissue Microarrays (TMAs).
Speed & Flexibility:
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Timeline: Weeks, not months
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Cost: A fraction of a GLP study
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Utility: Identify off-target binding before cell line development (CLD) is finalized
The Bridge to GLP (Assay Transfer):
We don't just run the screen; we develop and optimize the assay. We establish and validate the rigorous IHC protocol and facilitate a seamless transfer to your GLP partner (or our partner Flagship Biosciences) for the final IND-enabling study.
Module 5: Clinical Biomarkers & Stratification
Extending Capabilities into the Clinic
[Right Patient]
Patient Stratification: We use quantitative IHC/ISH to identify "Responder vs. Non-Responder" profiles, optimizing your clinical trial design.
The Regulatory Bridge: Through our strategic partnership with Flagship Biosciences, we seamlessly transition your assay into a CAP/CLIA-certified environment for regulated clinical sample analysis.
Exploratory Endpoints: Quantitative analysis of mechanistic biomarkers in trial biopsies.
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