In order for trials to be successful, it is important that assays and testing methods used in the nonclinical lab transition easily to the clinical phase. Drawing from our broad portfolio of laboratory support services, our scientists have the capability and the experience to develop and transfer methods efficiently and expeditiously to meet the needs of our clients. In many cases, our scientific staff have been an integral part of our clients’ drug development from the earliest stages of nonclinical work. This ongoing relationship results in a deep understanding of a client’s work, and fosters continued collaboration across the clinical study team. Combined with our data management and transfer expertise, this approach allows us to produce detailed, on-time clinical data to support drug approval and help our clients effectively make sound go/no-go decisions.
eGuide: Bioanalysis from Early-Stage to Clinical Drug Development
Accounting for modality complexity, evolving regulatory expectations, and the critical importance of upfront planning, this eGuide addresses how to identify risks early and align your bioanalytical strategy with the needs of your compound, your timeline, and your team.
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As clinical trials begin, further in vitro and in vivo nonclinical studies performed within our global network of facilities provide additional information to support the continuation of clinical trials.
- Laboratory Sciences
- Clinical Pathology
- Biologics Manufacturing
- Biologics Testing Solutions
- Specialty Toxicology
Over the years, we’ve made significant investments in highly trained scientific, technical and support staff, superior facilities and technologically advanced instrumentation. These combined give us the ability to rapidly produce reliable data for many types of analyses using networked, validated data management systems.
Our comprehensive laboratory support services include:
- Bioanalysis
- Biologics testing services
- Biomarkers
- Clinical kitting services
- Data management
- Immunogenicity and neutralizing antibody assays
- Microsampling
- Molecular biology qPCR studies
- Pharmacokinetics
- Quality control
- Stability testing
- Technology platforms
eGuide: Biomarker Solutions from Discovery to Clinical Trials
Learn how strategic biomarker integration can accelerate research & de-risk pipelines to bring life-saving therapies to patients faster. This guide helps you uncover smarter ways to de-risk studies and accelerate timelines, without compromising scientific rigor.
Read the Guide
Our complete range of clinical pathology laboratory services supports animal models, discovery, preclinical studies and/or clinical trials with extensive knowledge of animal and human hematology, coagulation, clinical biochemistry and urinalysis. Specialized pathology laboratory services are available for assays/biomarkers for specific research requirements or drug safety studies.
Our staff, including pathologists certified by the American College of Veterinary Pathologists and the European College of Veterinary Clinical Pathology, has expertise across the spectrum of major therapeutic areas and routinely assesses and interprets data from regulatory and investigative/research studies. With six state-of-the-art clinical pathology labs, we can support all stages of the human and veterinary drug development process and conduct research in accordance with the current GLP and GCP standards.
From early preclinical formulation development through clinical and commercial product release, we provide timely, tailored science, and trusted products and services to support the development of your biologic.
Antibody/Protein Manufacturing
Our team of scientists can ensure the quality, consistency, and integrity of a client's cell and viral banks, promoting a smooth and successful outcome for their manufacturing campaigns.
Our manufacturing/production capabilities include:
- Mammalian and microbial cell banking
- PhI/II vaccines and viral challenge stocks
- Monoclonal and polyclonal antisera production
Cell and Gene CDMO Solutions
With the benefit of a shared quality system, faster internal technical transfer, and process crossover between teams helping to reduce program bottlenecks and providing a seamless experience, we are uniquely positioned to help our cell and gene therapy clients accelerate and achieve critical development goals from discovery to commercialization. We have supported the development of 10 FDA-approved cell and gene therapies and have conducted more than 900 studies in this field over the past year. Our aim is to enhance client access to this wealth of scientific and regulatory experience as well as harnesses the power of our multidisciplinary bench of experts to problem solve in a collaborative manner every step of the way.
Explore our cell and gene therapy CDMO solutions:
The approval process for ensuring the identity, potency, purity, safety, and effectiveness of a biologic is complex, and its effective navigation is critical to the ultimate commercial success of a product. With more than 50 years of experience, our Biologics Testing Solutions group has the proven knowledge, expertise, and capacity to address challenging projects for biotechnology and pharmaceutical companies worldwide. Our primary emphasis is on quality, which is enforced through continuous training and internal audit programs, ensuring that our practices are in compliance with global regulatory guidelines.
We support clients throughout the drug development continuum, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Our facilities in the US, UK, Ireland, France, and Germany are part of a global scientific network, allowing us to offer clients greater flexibility, experience, and expertise to maximize resources and optimize results based on specific program needs.
Our comprehensive biologics testing services include:
Our exceptional team of scientists regularly designs and performs safety programs ranging from acute through chronic toxicity to carcinogenicity, with a broad range of animal models and numerous routes of administration.
Our specialty toxicology services include: