Creative Biolabs launches integrated preclinical platform to accelerate biotherapeutics development and de-risk IND submission
Integrated pre-clinical platform to accelerate therapeutic development
23 Jan 2026
Creative Biolabs has launched its newly consolidated, end-to-end preclinical development platform. This integration streamlines the critical path from lead optimization through toxicology, directly addressing industry fragmentation and accelerating time-to-IND submission for complex biologics.
The biopharma industry faces high attrition rates due to the translational gap in preclinical assessment, where fragmented outsourcing leads to delays, data silos, and administrative complexity.
Creative Biolabs’ new platform acts as a single point of contact, eliminating communication barriers and enabling parallel development tracks, significantly reducing the R&D cycle time. The platform strategically integrates multi-year experience across animal model assessment, gene editing, functional characterization, pharmacokinetics (PK), pharmacodynamics (PD), and toxicology studies.
Pillar 1: Precision models and gene editing
The first pillar, precision models, is built on integrated gene editing capabilities. Advanced CRISPR-based systems are utilized to rapidly generate specialized genetically engineered models (GEMs). This is critical for overcoming the species specificity issue, a primary hurdle in translational science. The platform offers a comprehensive portfolio of humanized mouse models (HMMs), including immune checkpoint knock-in mice and humanized SRC SCID models, essential for accurately evaluating the efficacy and safety of complex immunotherapies (e.g., CAR-T, ICIs) in a human-like system.
Pillar 2: Robust functional characterization
The second pillar, functional validation, provides comprehensive antibody in vitro functional characterization services to confirm the therapeutic molecule's precise mechanism of action and quantitative potency, moving beyond simple antigen binding. Efficacy is quantified by rigorous Fc-mediated effector function analysis, including GLP-ready ADCC (reporter gene/real-time), CDC, and ADCP assays. This functional assessment ensures developers select the strongest lead candidates and generates robust, "regulatory grade" data early in the pipeline.
Pillar 3: Integrated translational intelligence (In vivo PK/PD/Tox)
The third pillar, translational intelligence, integrates in vivo PK studies with PD and toxicology assessments. Services cover both rodent and non-rodent species, utilizing specialized PK disease models to define the optimal therapeutic window. The key strength is establishing a robust PK/PD relationship in validated animal models, which is critical for defining the optimal human therapeutic dose and dosing schedule in preclinical planning, and significantly de-risking early clinical trials.
Furthermore, state-of-the-art physiologically based pharmacokinetic (PBPK) Modeling is employed. These mechanistic tools integrate in vitro data with physiological parameters, providing high-confidence predictions for human dosing schedules and significantly de-risking early clinical trials.
The platform is further enhanced by an AI-driven core that leverages predictive modeling, digital twins, and organ-on-chip platforms, providing superior predictive accuracy and ethical, cost-effective R&D solutions.
