Integrated Discovery Biology Services

Molecular Biology

PI Health Sciences Discovery Services offers comprehensive molecular and cell engineering capabilities, supporting drug discovery programs from plasmid design to protein expression validation. Our platforms enable both prokaryotic and mammalian systems, ensuring flexibility across diverse therapeutic targets and modalities.

We specialize in generating custom engineered cell lines, with efficient timelines:

• Stable cell pool: ~4–5 weeks
• Stable cell line: ~10–12 weeks

Our expertise spans advanced transfection and delivery technologies:

• Plasmid, Lentiviral, Adenoviral, and BACMAM vector systems
• Stable and transient transfections
• Electroporation and lipid nanoparticle-based delivery

Plasmid DNA & Molecular Cloning

We provide end-to-end plasmid design and molecular cloning services, enabling reliable construct generation for downstream discovery workflows.

• Plasmid design, transformation workflows, and culture expansion
• Competent cell preparation and bacterial amplification
• Blunt-end and sticky-end cloning strategies
• Site-directed mutagenesis and advanced cloning methods
• Sequence- and ligation-free cloning approaches

Optimized systems across standard bacterial platforms:

• DH5α
• Stbl3
• JM109

Transcript Expression

Our transcript analysis workflows support target validation and pathway characterization through accurate gene expression profiling.

• RNA extraction from cell lines, tissues (fresh/frozen), and FFPE samples
• Quantitative gene expression using SYBR Green and TaqMan qPCR
• Copy number variation (CNV) analysis
• Relative expression profiling

Protein Expression & Quantification

We offer comprehensive protein expression verification and quantification using multiple orthogonal platforms for high-confidence data.

• Native PAGE and SDS-PAGE analysis
• Western blotting and automated systems (JESS)
• ELISA-based quantification
• Flow cytometry (FACS)
• Biacore-based interaction and binding analysis
• Co-immunoprecipitation for mechanistic studies

Cell Engineering

Our advanced cell engineering platforms enable precise functional and mechanistic studies in biologically relevant systems.

• Stable and transient expression systems (plasmid, viral, BACMAM)
• Electroporation and lipid nanoparticle-based delivery
• Reporter gene and promoter-based assays
• IRES-enabled multi-protein expression systems
• siRNA/shRNA-mediated gene knockdown models

Targeted and specialized expression capabilities:

• Tagged protein expression
• Organelle-specific localization (Golgi, ER, nucleus, membrane)

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Target Identification and Validation

PI Health Sciences Discovery Biology provides integrated target identification and validation services to support early discovery programs from hypothesis generation to target confirmation. Leveraging advances in functional genomics, systems biology, and translational disease models, we enable the identification of high-confidence therapeutic targets directly linked to disease biology.

Our platforms establish target relevance, mechanism of action (MoA), and biological tractability, ensuring selected targets are:

• Biologically relevant and disease-linked
• Mechanistically validated
• Druggable and development-ready
• Aligned with downstream therapeutic strategies

Target discovery and validation services include:

Target Selection & Characterization

We support systematic prioritization of targets through integrated biological and druggability assessment frameworks.

• Target prioritization based on disease relevance
• Druggability and tractability evaluation
• Biological characterization aligned with therapeutic strategy
• Selection of high-value targets for downstream development

Disease Mechanism Understanding

We investigate disease-driving biology to establish the causal role of targets in disease progression.

• Functional biology and pathway-linked validation
• Mechanistic studies linking targets to disease phenotype
• Evidence generation to support early discovery decisions

Model Selection & Assay Planning

We design fit-for-purpose assay systems using disease-relevant biological models.

• Cellular and molecular assay design
• Selection of appropriate disease models
• Alignment of assay readouts with validation objectives
• Scalable workflows for screening and validation

Omics (Genomics)

Our genomics-driven platforms enable systematic target identification and prioritization.

• Integrated omics data analysis
• Functional genomics-based validation
• Mapping target–disease associations
• Identification of biologically actionable targets

Pathway Analysis

We deliver mechanistic pathway validation to confirm target involvement in biological systems.

• Signaling pathway mapping and profiling
• Biomarker response and downstream effect analysis
• Functional modulation studies
• Strengthening translational relevance of targets

Knock-in/Knock-out Studies

We provide robust genetic perturbation platforms to validate target dependency and function.

• CRISPR-based knock-in and knock-out systems
• RNA interference (siRNA/shRNA) approaches
• Functional impact and pathway consequence analysis
• Mechanistic validation in cellular systems

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In Vitro Biology Assays & Instrumentation

At PI Health Sciences, our in vitro screening and biochemical assay platforms provide the experimental backbone for integrated drug discovery across small molecules, peptides, and biologics, including monoclonal antibodies. Leveraging advanced assay technologies and scalable formats, we enable rapid hit identification, potency confirmation, and mechanistic characterization, supporting confident progression through discovery pipelines.

Our platforms are designed to deliver high-quality, decision-ready data across early discovery stages.

Biochemical Screening Capabilities

We offer comprehensive biochemical screening solutions to evaluate enzyme activity, binding interactions, and dose-response relationships.

• Enzyme activity and affinity-based binding assays
• Dose–response profiling and IC₅₀ determination/li>
• Percent inhibition and full curve generation
• Medium- to high-throughput screening formats

Detection technologies include:

• Fluorescence intensity and fluorescence polarization
• Time-resolved fluorescence (HTRF)
• Luminescence and absorbance
• AlphaLISA assays
• Calcium flux assays

Biophysical Interaction Analysis (SPR)

We provide quantitative Surface Plasmon Resonance (SPR)–based interaction analysis using high-throughput systems such as Biacore, enabling precise characterization of molecular interactions.

• Peptide–protein and protein–protein interactions
• Antigen–antibody binding analysis
• Small molecule–protein interaction profiling

Key outputs include:

• Association rate (k_on)
• Dissociation rate (k_off)
• Binding affinity (K_d)
• Epitope binding and relative potency assessment

Functional & Translational Screening

To enhance biological relevance, we integrate biochemical screening with cell-based and ex vivo functional assays.

• Secondary cell-based assays for cytotoxicity and proliferation
• Phosphorylation and pathway activation studies
• Cytokine release and immune functional assays
• Mechanism-of-action (MoA) validation workflows

Selectivity & Translational Profiling

We strengthen downstream confidence through selectivity and translational validation.

• Selectivity profiling across isoforms and species
• Ex vivo studies using patient-derived tissues
• Immune cell functional profiling and biomarker analysis

In Vitro Screening Services Include

• Primary biochemical screening (enzyme activity and binding assays)
• High-throughput platforms: fluorescence, luminescence, HTRF, AlphaLISA, absorbance, calcium flux
• Secondary functional cell-based assays for mechanistic validation
• SPR-based interaction analysis for kinetics, affinity, and epitope binding
• Selectivity assessment and ex vivo translational studies

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In Vitro Pharmacology

PI Health Sciences Discovery Biology provides integrated or standalone (FFS) in vitro pharmacology services to support programs from target validation through preclinical candidate (PCC) selection. Our platforms enable comprehensive evaluation of target engagement, mechanism of action (MoA), and biomarker responses, generating decision- ready data across discovery stages.

We develop bespoke assays with validation and qualification (QC) in medium- to high- throughput formats to support compound characterization across diverse modalities.

Our capabilities include:

• Target validation and biochemical/biophysical screening
• Cell-based functional assays and MoA exploration
• Target engagement and biomarker profiling
• Assay development, validation, and QC

We bring extensive experience across targets and modalities:

• Small molecules, PROTACs, molecular glues, bicyclics
• Monoclonal and engineered antibodies

Supported therapeutic areas include:

• Oncology and Immuno-oncology
• Autoimmunity and Inflammation
• Neurologic disorders

Small Molecule Screening

We deliver scalable, high-throughput biochemical and functional screening assays to support small molecule discovery, from early hits to optimized leads.

• Enzyme activity, binding, and kinetic characterization
• Assay formats: fluorescence, absorbance, FP, luminescence
• FRET/TR-FRET, AlphaScreen, NanoBRET
• Scalable platforms: 96-, 384-, and 1536-well formats

Specialized GPCR and signaling assays:

• SPR/Biacore and FACS-based binding studies
• Functional readouts: calcium flux, cAMP, β-arrestin, IP-1

Targeted protein degradation (TPD) support:

• Binding and ternary complex assays
• Protein degradation confirmation (WB/JESS)
• Ubiquitination profiling

Large Molecule Screening

We provide integrated screening platforms for peptides, monoclonal antibodies, and engineered biologics, enabling rapid progression through early discovery.

• Affinity and kinetic profiling (Biacore 8K SPR)
• FACS-based binding assays
• ELISA-driven specificity testing
• High-content flow cytometry workflows

Therapeutic Area Specific Cell-Based Functional Assays

We design disease-relevant cellular models to support MoA exploration and translational screening across key therapeutic areas.

Autoimmunity & Inflammation

• Immune cell activation and differentiation (T, B, NK, macrophages, DCs, MDSCs, Tregs)
• Cytokine profiling and mixed lymphocyte reactions
• Cytotoxicity systems and immune functional assays
• Antibody-mediated effector assays: ADCC, CDC, ADCP

Oncology & Immuno-Oncology

• Cytotoxicity and proliferation assays (e.g., Incucyte)
• Angiogenesis, apoptosis, and invasion/motility studies
• Phosphorylation pathway analysis (WB/JESS)
• Cell cycle and cell death profiling

Tumor microenvironment (TME) models:

• Immune cell population mapping
• Checkpoint marker evaluation
• Immune–tumor co-culture systems

Fibrosis

• Epithelial–mesenchymal transition (EMT) models
• Biomarker-linked gene expression (qPCR)

Ex Vivo Immunophenotyping & Immune Profiling

To enhance translational relevance, we offer advanced ex vivo immune profiling using patient-derived and primary biological systems.

• Sample types: patient tissues, lymphoid samples, peripheral blood
• Flow cytometry-based immune subset profiling: CD4/CD8, NK, B cells, DCs, MDSCs, macrophages
• Immune activation, exhaustion, and checkpoint analysis: PD-1, TIM-3, LAG-3, OX40, 4-1BB

Functional immune readouts:

• Cytokine and chemokine profiling (ELISA, intracellular flow)
• Lymphoid tissue response assays
• T cell–dependent antibody response (TDAR) studies

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Organoids

At PI Health Sciences, our organoid-based translational platforms enable physiologically relevant disease modeling and predictive drug response assessment beyond conventional 2D systems. By capturing tissue-level architecture, cellular heterogeneity, and functional responses, our 3D models bridge early discovery with translational biology.

These platforms support mechanism exploration, therapeutic screening, and patient-relevant validation, improving confidence in downstream decision-making.

3D Modeling & Translational Capabilities

We develop scalable organoid and 3D cell culture systems to better reflect in vivo biology and enhance predictive accuracy.

• Advanced 3D cell culture systems surpassing traditional monolayer assays
• Improved physiological relevance and translational predictivity
• Support for mechanism-of-action (MoA) and functional studies
• Scalable formats for screening and validation

Organoid Platforms & Applications

Cell Line–Derived Spheroids

We generate reproducible spheroid models to enable robust and scalable drug screening.

• Tumor-like architecture and microenvironment simulation
• High-throughput drug response testing
• Reproducible systems for comparative studies

iPSC-Derived Organoids

Our induced pluripotent stem cell (iPSC)–based organoids model patient-relevant biology and disease-specific phenotypes.

• Generation of functional mini-tissues
• Disease modeling and pathway exploration
• Support for personalized and precision medicine approaches

Patient-Derived Organoids (PDOs)

We establish clinically relevant models directly from patient samples to enhance translational relevance.

• Patient-specific drug response profiling
• Personalized therapeutic evaluation
• Translational biomarker identification and validation
• Improved prediction of clinical outcomes

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Large Molecules

At PI Health Sciences, we provide specialized Discovery Biology workflows for screening and characterization of large molecule therapeutics, including monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), and bi-specific platforms.
Our integrated screening cascade is designed to generate early, decision-ready evidence across:

• Target binding and affinity strength
• Internalization and cell-surface engagement
• Immune-mediated functional activity
• Mechanistic and translational relevance

By combining scalable assay formats with biologically meaningful readouts, we enable confident selection and progression of biologic candidates across diverse therapeutic programs.

Binding Activity Assessment

PI Health Sciences initiates large molecule screening through robust binding activity assays to confirm antigen engagement and functional targeting. Our platforms support both recombinant antigen-based and cell-based binding evaluation.

Key capabilities include:

• Sandwich ELISA binding assays using Fc-tagged recombinant antigens
• FACS-based binding analysis using antigen-overexpressing CHO cell systems
• Binding assessment across varying expression levels (high, medium, low)
• Bi-specific binding assays across both tumor antigen and T-cell arms

Affinity Determination and Kinetic Profiling

To advance screening hits, we perform quantitative affinity determination using Biacore-based kinetic analysis. These studies provide critical insights into interaction strength and binding dynamics.

Services include:

• SPR-based affinity characterization of lead molecules
• Association and dissociation kinetic profiling
• Comparative ranking of candidate antibodies and constructs

Internalization and ADC Functionality Assays

For ADC and targeted biologic modalities, PI Health Sciences conducts internalization assays to quantify cellular uptake and target-driven internal trafficking, supporting payload delivery evaluation.

Capabilities include:

• High-throughput MMAF internalization assays
• Internalization kinetics using pH-sensitive dye methodologies
• Cellular uptake profiling to support ADC optimization

Immunology and Bispecific Functional Assays

For bi-specific molecules, screening extends into immune-mediated functional biology, enabling evaluation of T-cell redirection, conjugation formation, and target-specific cytotoxicity.

Key assays include:

• Bi-specific mediated T-cell and target cell conjugation analysis
• Cytotoxicity profiling in relevant co-culture systems
• Specificity assessment through selective effector cell depletion studies

Translational Extension and Cell Line Validation

PI Health Sciences further supports translational progression by extending cytotoxicity and functional assays across diverse suspension and adherent cell line models, ensuring activity consistency across clinically relevant contexts.

Applications include:

• Functional validation across multiple tumor and immune cell origins
• Translational relevance assessment beyond engineered systems
• Lead optimization support through expanded cell-based profiling

Throughput and Deliverables

Our large molecule screening platforms are scalable across:

• 24, 96, and 384-well assay formats
• Approx. ~100 molecules per week per FTE

Deliverables include:

• Percent inhibition
• Dose-response relationships
• IC₅₀ determination
• Binding, affinity, and internalization profiling
• Functional immune-mediated activity assessment

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Therapeutic Areas

PI Health Sciences Discovery Biology delivers end-to-end assay expertise across key therapeutic areas, supporting integrated drug discovery from early screening through translational validation. Our platforms span biochemical, cellular, genomic, proteomic, and advanced tumor model systems, enabling robust evaluation across diverse therapeutic modalities.

We support:

• Small molecules, peptides
• Monoclonal antibodies, bispecifics, engineered antibodies
• Emerging therapeutic modalities

Our integrated platforms ensure mechanism-driven insights and clinically relevant data generation.

Assays

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