Antibody & Protein Pharmacology Services
Creative Biolabs provides the scientific clarity required to navigate the complexities of large molecule development, converting preclinical data into actionable, regulatory-compliant human dose predictions. Our core capability lies in accurately characterizing unique biologic challenges like target-mediated drug disposition (TMDD) and FcRn recycling, which dictate dosing for monoclonal antibodies (mAbs), fusion proteins, and antibody-drug conjugates (ADCs). By integrating specialized assays with advanced modeling, we deliver a confident, scientifically justified rationale for your research.
Introduction What We Can Offer Types of Our Services Why Creative Biolabs Customer Reviews FAQs Related Services Contact Us
The Role of Preclinical Pharmacology in Immuno-oncology
Pharmacology is a key component concerned with the study of drug action in animal models, which is essential and determinant to IND approval and ultimate NDA approval for a drug candidate. To support cancer therapy, the immunotherapeutic drugs can be broadly classified as small chemical molecules, viruses, therapeutic engineered immune cells, cytokines, and antibodies, which exert obvious suppressive or eliminating roles for tumors. The pharmacology studies during preclinical testing focus on biochemical or physiological effects on tested animal models.
Discover how we can help - Request a consultation.
Fig.1 Integrated services for preclinical testing.
What We Can Offer
To support a wide range of cancers and corresponding immunotherapies, we provide the following immuno-oncology models to evaluate the drug characterization and safety profiles. If your target disease can't be developed in these models, please contact us for custom services. To enable greater prediction of success in the clinics, we provide the animal models, including non-human primates, dogs, mice, rabbits, guinea pigs, and others, in our services. We also offer a wide range of animal models.
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Immuno-Oncology Models
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Animal Models
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✓Immunodeficient animal models
✓ Nude models
✓ Severe combined immunodeficiency models (SCID)
✓ Immunocompetent models
✓ Cryopreserved oncology models
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✓ Syngeneic Models
✓ Humanized Models
✓ Cell Line Derived Xenografted Models
✓ Patient Derived Xenografted Models
✓ Patient Derived Organoid Model
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Our Immuno-Oncology Pharmacology Services
Creative Biolabs is an end-to-end drug discovery and development CRO with decades of experience in conducting non-GLP and GLP integrated pharmacology solutions according to the needs of our clients to evaluate the pharmacological effects of drug candidates. In addition, our experienced technicians operate with a strong theoretical basis to be your best partner for developing, validating, conducting, and analyzing animal models and pharmacology data. We offer flexible services for the custom development of various types of cancer animal models to meet the requirements of our clients in numerous oncology areas. Our service portfolio includes drug characterization, dermal absorption, drug metabolism and pharmacokinetics, toxicokinetics, and safety pharmacology.
Fig.2 Integrated pharmacology services.
In Vitro ADME
Assays defining binding kinetics, cellular uptake, degradation rates, and stability to inform early candidate selection.
In Vitro Toxicity
Cell-based assays to assess potential off-target effects and cytotoxic mechanisms before in vivo studies.
In Vivo Safety Pharmacology
Definitive studies measuring vital functions (e.g., cardiovascular, respiratory) to assess the risk profile of the candidate.
In Vivo PD
Studies to measure biological response and target engagement, including receptor occupancy (RO) and functional assays like ADCC, ADCP, and CDC.
In Vivo Efficacy
Non-clinical model testing (syngeneic, PDX, humanized models) to establish proof-of-concept and determine the minimum effective dose.
In Vivo DMPK Service
Comprehensive studies to determine the absorption, distribution, metabolism, and excretion (ADME) profile, including non-linear PK modeling (TMDD).
Nonclinical Pathology Service
Histopathology and clinical pathology support to analyze tissue changes and clinical parameters across all toxicology and safety studies.
Highlights
Senior Scientific Leadership and Therapeutic Focus
Our team consists of senior scientists with cumulative years of extensive therapeutic expertise, specifically in a wide range of cancer immunological and other challenging therapeutic areas. This deep, targeted knowledge ensures the highest level of insight and data interpretation for complex molecules.
Integrated Pharmacology Platform
We deploy a single, integrated pharmacology platform that seamlessly combines in silico predictions, bioanalytical assay performance, and in vivo study execution to maximize the success of your studies and guide confident decision-making during lead optimization.
Targeted Model and Assay Validation
We specialize in model and assay development and validation for non-linear kinetics (TMDD, FcRn) and complex mechanisms of action. We provide ultra-sensitive methods for quantifying drug, target, and biomarker engagement across all preclinical samples.
Robust Data for Preclinical Advancement
We deliver comprehensive, defensible datasets from in vivo studies, including detailed toxicokinetic (TK) and safety pharmacology profiles, providing the foundation required to justify dose selection and move the most promising candidates forward.
Contact us today to schedule a confidential consultation and discover how our specialized pharmacology expertise can accelerate your lead candidate to a commercial reality.
Customer Reviews
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Accuracy
Using Creative Biolabs' ultra-sensitive bioanalytical platform in our research has significantly improved the detection limits for our low-concentration PD biomarkers, giving us confidence in our translational predictions. - J***n W.
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Model Confidence
The QSP model provided by Creative Biolabs for our ADC was essential. It accurately predicted the complex non-linear clearance of the conjugated payload, which was instrumental in justifying our clinical dosing strategy. - K***e L.
FAQs
Q: Can you handle the complexity of multi-component biologics, such as ADCs?
A: Yes, handling complex molecules like ADCs is a specialty. Our QSP modeling platform is specifically designed to simultaneously track all components: total ADC, conjugated payload, and free payload. This allows us to precisely model the release and disposition of the cytotoxic agent and optimize the crucial therapeutic window.
Q: What precautions do you take against immunogenicity (ADA) interference in PK assays?
A: Immunogenicity is a critical concern. We use state-of-the-art assay formats and validation strategies, including acid dissociation and specialized buffers, to minimize matrix effects and overcome drug interference.
Related Services
Tumor Profiling for Biomarker Discovery
We perform deep characterization of the tumor microenvironment (TME) using multiplex IHC/IF and genomics to identify predictive and pharmacodynamic biomarkers. This data is essential for patient stratification and confirming MoA in preclinical efficacy models.
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Bispecific Antibody Engineering
Specialized PK/PD modeling, ultra-sensitive bioanalysis, and customized safety assessments tailored for the unique challenges of complex, multi-target biologics, such as bispecific antibodies (BsAbs) and Trispecifics.
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How to Contact Us
Creative Biolabs is dedicated to offering in vivo pharmacological assays that can assist in selecting the optimal drug candidates for further clinical development. We are committed to complying with ICH guidelines to meet regulatory requirements to facilitate the future IND enabling. Please feel free to contact us for a deep conversation.
