Biologics Testing CRO Services
Background
- Established in 2002 as part of the RMS division and joined the Biologics group in 2012
Laboratories and Facilities
- 15,000 ft2 (1394 m2)
- Animal holding rooms, surgical suite, formulations, and serology laboratories
Staff
- 30+ employees
Service Areas/Study Types
- In vivo adventitious agents testing
- designed to meet various regulatory requirements (FDA, European Pharmacopeia)
- Mouse, rat, and hamster antibody production testing (MAP, RAP, HAP)
- In vivo potency and immunopotency
- General safety testing
- Tumorigenicity
Compliance, Certifications, Accreditations and Professional Affiliations
Our Wilmington facility operates in compliance with the requirements of the following regulatory agencies or accredited organizations:
- United States Food and Drug Administration (FDA)
- European Medicines Agency (EMA)
- International Conference on Harmonization (ICH)
- Health Products Regulatory Authority (HPRA) – formerly Irish Medicines Board (IMB)
- Association of Assessment and Accreditation of Laboratory Animal Care (AAALAC)
Quality and Process Initiatives
- Excellent regulatory compliance audit history
- Operational Excellence – Lean Program
- Online data collection and integrated instrumentation
- Humane Care Imperative for animal welfare
- On-site IT support and backup
Humane Care Initiative
We are a worldwide leader in the humane care of laboratory animals. We work hand-in-hand with the scientific community to understand how living conditions, handling procedures and stress play an important role in the quality and efficiency of research.