Key Production Practices
Newport offers several adjuvant choices to meet your needs:
- Trigen 21™ - an oil based adjuvant
- Ultragen - an oil based adjuvant designed for sustained release
- A metallic salt based adjuvant
- A purified saponin adjuvant
- E-Cor-Gel™ - a metallic salt based adjuvant with increased enhancement
Available Formats
- 2cc liquid
- Super concentrate
- Freeze-dried
- SoliDose - Click here for more information.
Safety Protocols
All of Newport’s autogenous biological are subject to strict safety testing as per USDA mandates, spelled out in the 9CFR (Code of Federal Regulations). All biologics are tested for safety, purity, and genus/species identity prior to release.
The quality control testing begins before a product is ever bottled. During the production process, samples of product fluids are screened by several in vitro test methods. These tests validate internal harvest criteria that have been established for various products. As product is bottled, a USDA-authorized sampler selects a predetermined number of samples for testing. Some of these samples are shipped to the Center For Veterinary Biologics in Ames, Iowa. The remaining samples are delivered in locked coolers to the Quality Control Facility. Upon arrival, the samples are documented, and retention samples are placed in a locked walk-in cooler for long-term storage.
Testing on a product begins within one business day of the product being bottled. We perform all three USDA-required tests for autogenous products: sterility, lab animal safety, and residual formaldehyde testing. The first test that samples must undergo is sterility testing, which confirms that no viable bacteria or fungi are present in the product. Two media types are inoculated with the product, and they are observed for growth for 14 days. Products also undergo a lab animal safety test. Newport has a large laboratory at the QC building dedicated solely to animal testing. Each animal is injected with a half-cc of the product being tested, and injected animals are observed for seven days. Products inactivated with formalin are tested for formalin content. A chemical assay determines the amount of residual-free formaldehyde in the product. These levels must not exceed maximum levels established by the USDA.
All testing information, as well as CVB product releases, will be forwarded to the Quality Assurance department. The QA department will review all testing documents as part of the product release process.
