From Hit to IND -

Advance Your Drug

Pipelines Efficiently

BioLegacy is equipped to take your pipelines from lead optimization through IND while providing you with the robust data you need to make critical pipeline decisions with confidence.

 

  • In vitro screening and custom assay development to characterize your discovery pipelines identify leads.
  • Hundreds of existing in vivo models along with expert model development, including in NHPs, to provide you with rich, translational data and de-risk your pipeline.
  • IND-enabling GLP studies to guide you confidently to your first-in-human trials.

 

Our “right sized” approach enables us to provide a holistic in-house service while retaining the agility and flexibility to be fast, responsive, and efficient. Don’t wait to move your pipeline forward. Tell us your preclinical study needs.

Drug Development Services

Toxicology

BioLegacy delivers the comprehensive safety profile required to confidently advance your program to the clinic. From discovery toxicology to GLP-compliant, IND-enabling studies, we thoroughly interrogate your therapeutic’s effect on all vital organ systems. Our expertise provides the definitive, submission-ready data needed to ensure your program is built on a foundation of regulatory success. From discovery toxicology to GLP-compliant, IND-ready studies, BioLegacy provides a full suite of toxicology and safety pharmacology services. We examine your therapeutic’s effect on all vital systems, including central nervous, cardiovascular, and respiratory functions. Our expertise in acute, subchronic, and chronic toxicity studies ensures a comprehensive safety profile to confidently advance your program to the clinic.

Pharmacology

BioLegacy elucidates the pharmacokinetics and pharmacodynamics of your therapeutic within highly translatable, disease-relevant in vivo systems. Our extensive expertise in pharmacology is coupled with a comprehensive suite of bioanalytical capabilities, ensuring the generation of definitive, high-fidelity data. Take advantage of our GLP-compliant data packages to facilitate accelerated IND submissions.

 

  • PK/PD
  • ADME
  • GLP / non-GLP
  • Many species, including NHPs
  • 100s of in vivo disease models

Animal Model Development

BioLegacy specializes in the de novo development of bespoke in vivo models, leveraging a comprehensive platform that includes transgenics, targeted mutations, xenografts, and chemical or surgical induction. This allows for the creation of precisely engineered biological systems to interrogate your therapeutic’s unique mechanism of action and deliver definitive, clinically-relevant data.

Ensure maximum translational fidelity and overcome the limitations of existing models with BioLegacy.

 

  • Complete range of research-relevant species, from mice to NHPs
  • Expertise in genetic, humanized, induced, and other models

In Vitro Screening

Optimize leads with confidence! BioLegacy’s range of screening platforms employ physiologically-relevant cellular assays, quantitative biophysical assays, and high throughput biochemical assays to provide rich mechanistic, affinity, and predictive ADMET data. De-risk your pipeline with rich data on target engagement, biomarkers, and mechanism-of-action.

 

  • Extensive biolanalytical capabilities
  • High-throughput biomarker analysis
  • Dozens of cell-based assays
  • Antibody production & characterization
  • Comprehensive in vitro toxicological analyses

Custom Assay Development

BioLegacy develops bespoke in vitro assays for the pharmacological deconvolution of your lead candidates. Our platforms provide definitive data on mechanism of action, potency, and cytotoxicity, moving beyond standard panels to answer your program’s most critical questions. By integrating our deep expertise in cellular phenotyping and high-throughput bioanalysis, we construct, optimize, and validate novel functional assays that deliver a precise, decision-enabling data package.

 

  • Choose from hundreds of cell lines
  • Custom bioanalytical method development
  • High-throughput formats available

Histology

BioLegacy provides definitive, submission-ready data histological and pathological data. Our full suite of techniques — from routine H&E to advanced IHC, ISH, and TUNEL assays — elucidate your compound’s efficacy, target engagement, and safety profile at the cellular level. BioLegacy delivers objective, reproducible data packages to empower go/no-go decisions and IND submissions.

 

  • In-house histology suite for rapid, professional turnaround
  • Advanced microscopy technologies & methods
  • Long-term sample & tissue storage
  • GLP or non-GLP
  • Certified board pathologist on staff
Medical Device Development Services

Medical Device Testing

Under the direction of world-renowned veterinary surgeon Dr. DingGang Liu, BioLegacy’s state-of-the-art surgical facility is engineered for complex medical device implantation and evaluation. Dr. Liu possesses technical expertise in microsurgical procedures for all classes of diagnostic, therapeutic, and assistive devices. This specialized capability ensures the generation of robust data to de-risk your program and facilitate a successful IDE submission.

Additional Services

Vivarium Rental

BioLegacy’s new 40,000 square-foot vivarium provides capital-efficient infrastructure for the expansion of your in vivo programs. The facility is engineered to exceed AAALAC standards, featuring an Edstrom Watchdog system for precise environmental control of temperature, humidity, and pressure. This state-of-the-art infrastructure can house a comprehensive range of small and large animal models, ensuring robust support for complex, multi-species studies.

Confidently Advance to Human Trials!

Don’t Wait - Contact us Today

Working with BioLegacy was a great experience. The team was very responsive and their dedication to my study was obvious. They caught a problem with our study design early on that could have resulted in serious flaws in our data, were able to suggest and execute protocol changes mid-study, and with minimal impact on cost and schedule. I would recommend BioLegacy to anyone!

Dr. FirstName LastName

Vice President of Department

Example Pharmaceuticals