Production Facility
Ausgenex’s state-of-the-art production facilities ensure the highest quality of our serum products, supporting the success of your research. Our commitment to quality and consistency in serum production is crucial for research success in cell culture, vaccine production, and monoclonal antibody development.
Adherence to cGMP Guidelines
Ausgenex’s production facilities operate under strict current Good Manufacturing Practice (cGMP) guidelines and are registered with [XXXX]. From raw serum collection to the final sterile-filtered product, we meticulously control and document every process, ensuring complete traceability from the animal to the final product that ships to you. Full batch records, including Certificates of Suitability, Certificates of Analysis, and other batch release documents, are available to all customers.
Benefits of Our Innovative Production Facilities
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Quality Control
Advanced technology ensures rigorous quality control, keeping serum products free from contaminants like viruses, bacteria, and endotoxins—vital for research and clinical applications.
Consistency
Modern facilities provide consistent batch-to-batch quality, essential for reproducible research results.
Sterility and Safety
With the latest sterilization and filtration methods, serum products meet strict sterility requirements, ensuring safety in sensitive experiments such as viral research or cell culture.
Customized Solutions
Our facilities enable the creation of tailored serum products, including those with reduced immunoglobulin G (IgG) or specially tested sera for specific research needs (e.g., hybridomas, stem cells).
Animal Serum Collection and Processing
Ausgenex’s animal serum collection and processing adhere to stringent standards to ensure high-quality products for research and manufacturing applications.
Customized Solutions
- Fetal Bovine Serum (FBS): Sourced from bovine fetuses via aseptic cardiac puncture performed by skilled operators in specialized areas within the abattoir. This method minimizes bacterial contamination and endotoxin presence. After collection, the raw serum undergoes centrifugation to separate blood cells, followed by freezing and shipment to our processing facilities. Pre-freezing, samples are tested for endotoxin and hemoglobin levels.
- Donor Sera: Collected through venipuncture from carefully controlled herds of live animals, these animals receive regular veterinary checks to monitor health. High standards of animal husbandry and controlled feeding diets are maintained to ensure the quality of the sera.
Processing of Animal Sera:
All raw sera are processed in Ausgenex’s state-of-the-art, cGMP-compliant, FDA-registered production facilities. The processing steps include:
- Thawing and Pooling: Raw serum is thawed and transferred to a 3000-liter pooling tank, where it is mixed to create a homogeneous pool.
- Filtration: The serum passes through a cascade of triple 0.1-micron filters to remove particulate matter.
- Bottling: The filtered serum is moved into class 100, fully automated bottling facilities, where it is filled into containers, labeled with product codes, batch numbers, and barcodes.
- Freezing and Storage: The labeled, sterile-filtered product is rapidly frozen at -20°C and stored in carefully controlled freezer rooms.
Quality Control and Documentation:
Each batch undergoes extensive testing by the Quality Control (QC) department. Detailed specifications and test results are available on the corresponding Certificate of Analysis (CoA). For FBS products, which must comply with higher safety standards, additional animal virus testing is conducted in line with 9CFR and EP3 regulations. The “Pharma Grade” FBS from Ausgenex meets these stringent regulations, with sera of both USA and Australian origin available. This grade is particularly suitable for industrial production and advanced cell therapy research.
Packaging
All FBS products are packaged in gamma-irradiated 100 and 500 ml PET bottles. Alternative containers and volumes are available upon request.
