Biologos offers standard and customized serum that is collected from prescreened donor animals that are maintained in controlled herds. The whole blood is processed to produce a Donor Horse Serum product that is frozen and shipped to Biologos for preparation, testing, and packaging.
Our quality control testing, tests for microbiological abnormalities, such as the presence of bacterial, fungal, and mycoplasma contamination and viruses. Serum is also tested for adventitious agents using modified procedures from the Code of Federal Regulations, Title 9, Section 113.53 (“Requirements for Ingredients of Animal Origin”). Once the absence of contamination has been confirmed and approved, batches of serum are prepared for the packaging and distribution process.
This process begins with the serum being thawed under controlled conditions and sterile filtered. Sterile filtration involves the serums being filtered through a series of filters in descending pore size, utilizing 0.2 micron filters for the final filtration step. Filling takes place in a laminar flow hood and a certified clean room to maintain ISO Class 5 conditions. The Donor Horse Serum is aseptically dispensed into gamma irradiated, sterile PETG or HDPE bottles and LDPE bioprocess bags (20-100 liter capacity). Filled containers are then labeled, frozen, and maintained at temperatures less than -5°C to preserve the product quality.
Each batch of serum meets the USDA standards for animal products, Biologos’ standard for raw materials, is traceable to date and collection location, and are processed using:
- Sterile filtering
- Heat inactivation
Biologos’ serums are trusted and have been used in the advancements of animal health and diagnostic labs globally for more than 40 years.