Nonclinical Solutions for
All modalities
Tailored solutions, expertise and insights across all modalities.
Capabilities
Effectively navigate the complexities of any modality backed by deep experience, tailored solutions and high-quality data and insights to support your drug development program.
Small molecule
More than half of all molecules in the drug development pipeline today are small molecules. And while there is more prescriptive guidance for small molecules than for biologics and cell and gene therapies (CGTs), outsourcing this work with an expert team brings speed and efficiency to your program. Across any phase, we help you complete the core battery of regulatory testing as well as identify tailored approaches to improve study designs and anticipate development challenges as they evolve.
- Experienced team delivering more than 130 IND/CTA-enabling programs each year
- Full testing capabilities across nonclinical study services
- Special study types/dose route/animal models to fit your study or therapeutic needs
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Biologics
Biological molecules are complex, so we offer a team of experts to collaborate with you. Together, we will address the unique aspects of your molecule to transform data into actionable insights.
- Thousands of biologics studies and over 40 integrated biologics IND/CTA-enabling packages in the last four years
- In vitro characterization of more than 250 biologics each year with analytical services defining critical quality attributes
- Proven regulatory know-how: our scientists have participated in the development of the ICH S6 guidelines
Cell and gene therapies
Rapidly move from discovery to preclinical development while avoiding unnecessary delays. Leverage insights from a global team with extensive cell and gene therapy experience, state-of-the-art facilities and access to novel, industry-leading technologies.
- Dedicated leaders and multidisciplinary team comprising scientific, operational and program management expertise
- Extensive CAR T-cell and other cell-based therapy experience and technologies to enable early product screening and future development
- Comprehensive safety toxicology, tumorigenicity, molecular bioanalysis, analytical testing and data support
Vaccines
Access a comprehensive suite of vaccine testing services, enabling the development of human and veterinary vaccines against viral and bacterial pathogens.
- More than four decades of experience working with a variety of vaccine types within a full range of in vivo and in vitro services
- Immunogenicity, efficacy and challenge studies
- State-of-the-art vivarium, including ABSL-2, and support studies ranging in size from small pilot studies to larger, complex designs
Custom antibodies
You need quality antibody reagents in consistent supply to avoid delays and optimize your workflow when developing your biotherapeutic. Our custom approach to custom-made antibodies results in high-quality, reproducible, sustainable reagents throughout the development life cycle.
- Quality antibody reagents eliminate lot-to-lot variation and produce better results than generic catalog antibodies
- Integrated antibody generation, characterization, storage and distribution option for critical reagents to support your nonregulated and regulated nonclinical data for discovery and safety assessment
- Deep capabilities and experience across a multidisciplinary team helps you anticipate regulatory challenges and offers strategic solutions to guide and enable you to make informed decisions faster
