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About Biowest USA
The Serum Specialist
High-quality Fetal Bovine Serum, animal-derived serums, and contract biomanufacturing for biomedical, pharmaceutical, and life science applications.
Over 35 Years of Serum Expertise
At Biowest USA, we are dedicated to providing the highest-quality Fetal Bovine Serum (FBS) and other animal-derived serums to support groundbreaking research in the biomedical, pharmaceutical, and life sciences industries.
With over 35 years of experience, we have earned a reputation as a trusted leader in contract biomanufacturing, offering a wide range of serum origins to meet diverse research and production needs.
Our state-of-the-art biomanufacturing facilities operate under a rigorous ISO 9001:2015 and ISO 13485:2016 registered quality management system, ensuring complete traceability, reproducibility, and compliance with industry standards.
Whether you work in cell biology, genomics, proteomics, virology, immunology, or drug development, we provide consistent, high-performance serums to help advance your research.
Why Choose Biowest USA?
Unmatched quality, global sourcing, and flexible contract manufacturing.
Unmatched Quality & Traceability
Full 9CFR Certificate of Analysis with customizable testing options. Our quality systems support complete traceability, reproducibility, and consistent performance.
Global Sourcing Advantage
A diverse selection of serum origins helps us meet specific research, application, and production requirements.
Contract Manufacturing
Partner with Biowest USA for customized serum processing and manufacturing solutions tailored to your needs.
Biomanufacturing
Precision & Quality in Serum Manufacturing
The Serum Specialist
Consistency and Quality You Can Trust
Biowest USA, known as The Serum Specialist, sets the benchmark for quality and expertise in serum collection.
We understand the importance of consistency and quality. Our manufacturing facilities operate in line with ISO 9001 and ISO 13485 standards, so you can trust that the product you receive will meet your expectations.
We understand the importance of consistency and quality. Our manufacturing facilities operate in line with ISO 9001 and ISO 13485 standards, so you can trust that the product you receive will meet your expectations.
Manufacturing Process
Thawing
- Computer-controlled and monitored thawing process
- The process is trended, and the trend is attached to the batch record
Manufacturing Process
Filtration
- ISO Class 7 filtration suite
- Yearly re-certification of the clean room
- All single-use technology
- No possibility of cross-contamination between lots
- No risk of cleaning-solution residue in the product
Manufacturing Process
Filling
- ISO Class 5 environment
- Yearly re-certification of the clean room
- Custom automated filling machine contained under an ISO Class 5 hood
- Every bottle is weighed for fill-volume accuracy
- Caps are automatically applied and torqued to a precise specification of 28 in-lbs
Manufacturing Process
From Filling to Freezer
- ISO Class 7 collection clean room
- Yearly re-certification of the clean room
- Multiple labeling options depending on customer needs
- Filtered serum is placed in a dedicated blast freezer immediately after bottle collection
Quality Assurance
Registered Quality Systems and Full Traceability
- ISO 13485 registered
- ISO 9001 registered
- Traceability from raw material to finished product
- Complete traceability of all components used in manufacturing
- Full 9CFR Certificate of Analysis offered*
*COA and testing needs can be customized to customer requirements.