|
CRM provides on-site support to the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, MD. In partnership with our government customers, CRM assists in the production and testing of vaccines and other biological products at the Pilot Bioproduction Facility (PBF) located at WRAIR. The PBF is a GMP-regulated facility specializing in vaccine production. It has the capacity to produce 1,000 – 10,000 doses per finished lot of clinical-grade material. In addition, the PBF has the capability for final formulation, vialing and quality control (QC) testing of final product. The PBF offers GMP manufacturing and testing services for both government agencies and pharmaceutical companies through commercial contracts and inter-agency or cooperative agreements.
Services Include:
- Pilot-scale production for Phase I/II
- Cell Seed/Bank Production
- Fermentation
- Purification
- Formulation/Vialing/Freeze-drying
- Comprehensive pre-clinical QC testing
- Protein concentration
- Purity
- Potency
- Identity
- Sterility
- Endotoxin
Demonstrated Experience...
The PBF has received awards for its role in developing vaccines for diseases like hepatitis A and meningitis. More recently the facility has played a key role in the development of vaccines for dengue fever, malaria, HIV, cholera, and shigellosis. Several of these experimental vaccines have progressed to advanced clinical testing.
Types of products manufactured by the Pilot Bioproduction Facility:
Recombinant subunit vaccines
Live-attenuated viral vaccines
Live-attenuated bacterial vaccines
Inactivated bacterial and viral vaccines
Skin test antigens
Therapeutic proteins
Adjuvants, placebos |
To request more information concerning CRM’s contract services, collaborative support, management support and/or on-site staffing, contact CRM’s business development office at 301-620-1987 or busdev@clinicalrm.com.
|
