Biologics Testing at Malvern, PA
Charles River's Malvern facility in Pennsylvania offers GMP-compliant support for the development of biological products, including vaccines and cell-based therapeutics. Established in 1987 by Tektagen and acquired by Charles River in 1998, the site has expanded significantly, now encompassing 42,000 square feet of advanced lab and manufacturing space.
With over 150 employees, the facility delivers a full suite of services ranging from testing to GMP manufacturing. Key testing capabilities include cell line characterization, protein and analytical chemistry, biosafety, microbiology, molecular biology, stability testing, and lot release. The team also specializes in custom method development, transfer, and validation to help clients meet regulatory and clinical milestones.
On the manufacturing side, the site supports the production of cell and virus banks—including mammalian, insect, stem, microbial, and yeast cells—as well as viral vaccine manufacturing. The facility features secure infrastructure, on-site IT support, and stringent environmental controls to ensure high-quality output at every stage.
Regulatory compliance is a cornerstone of Malvern's operations. The site is recognized by the FDA, EMA, HPRA, and USDA, and operates under Good Manufacturing Practice (GMP) guidelines. These accreditations affirm the facility's global readiness to support regulatory submissions and commercial manufacturing.
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Background
- Established in 1987 by Tektagen
- Acquired in 1998 by Charles River
- Facility expanded in 2008 and 2016
Staff
- 150+ employees
Laboratories and Facilities
- 42,000 square feet/3,900 square meters
- Extensive site security and monitoring systems
- Sample processing and storage
- On-site IT support and backup
Service Areas/Study Types
- Testing Services
- Cell line characterization
- Protein and analytical chemistry
- Lot and drug product release testing
- Biosafety testing including detection of adventitious viral agents and retroviruses
- Microbiology services
- Sterility
- Bioburden
- Mycoplasma testing
- Molecular biology services
- Stability testing
- Custom method development
- Method transfer and validation
- GMP Manufacturing
- Cell banking including
- Mammalian, insect and stem cells
- Microbial and yeast cells
- Virus banking
- Viral vaccine manufacture
- Cell banking including
Compliance, Certifications, Accreditations and Professional Affiliations
Charles River's Malvern facility operates in compliance with the following regulatory agencies or accredited organizations:
- Good Manufacturing Practice (GMP)
- Food and Drug Administration (FDA), USA
- European Medicines Agency (EMA)
- Health Products Regulatory Authority (HPRA) - formerly Irish Medicines Board (IMB)
- United States Department of Agriculture (USDA)
Quality and Process Initiatives
- Operational Excellence - Lean Program
The Malvern facility also drives continuous improvement through its Lean Operational Excellence program, streamlining processes to enhance quality and efficiency.
From method development to full-scale vaccine production, Charles River's Malvern site is a trusted partner for biopharmaceutical companies bringing innovative therapies to market.