GoldenWest Biologicals Inc

Golden West Companies is a supplier of biological products, specializing in the processing of human native matrixes used in the preparation of standards and controls for immunoassay and mass spectrometry applications. The company provides a range of products, including human donor products such as serum, plasma, and whole blood, as well as antigens, disease state plasma, and human fluids like cord blood and urine. They also offer protein fractions, OEM/contract manufacturing services, and specialty products like human serum albumin. The company serves various industries, including in vitro diagnostics (IVD) manufacturers, contract research organizations, contract manufacturing organizations, patient reference labs, and academic institutions.

Golden West Biologicals, Inc.® (GWB) is a privately held company headquartered in Temecula, California. The company was formed in 1989 to directly address the needs of diagnostic medical device manufacturers by providing a reliable and cost effective source of high quality raw materials. In addition to meeting product requirements, GWB is committed to providing excellent service. Excellence in service includes, but is not limited to, on time delivery, minimal lead-time, consistent product performance and working with clients to provide solutions or develop new products that meet their unique requirements.

THE PRODUCTS
GWB offers a vast line of biological products that are critical components for the development and manufacture of immunoassays. Products include processed human sera matrices, highly purified protein fractions, disease state plasmas, antigens and antibodies. GWB has also developed the Mass Spect Gold® and Seratrol™ product lines to address customer need for ultra-low human sera for ultrasensitive testing and matrix-effect free base material for calibrators and controls. Our products are shaped by our customers with new products being developed and tailored to each customer's needs; one customer at a time. GWB provides The Products of Reference.

QUALITY
GWB recognizes that quality is key in providing consistently high quality components to the diagnostic medical device industry. GWB is committed to quality and is ISO 9001:2008 registered. Quality is designed into all activities from raw material procurement through final product release. Employees are trained and instilled with the knowledge that quality is paramount in all activities. GWB adheres to its quality management system which ensures that products are manufactured in compliance to current Good Manufacturing Practices (cGMP). Products are inspected and tested to verify lot-to-lot consistency and conformance to specifications. Each product is accompanied with a Certificate of Analysis which succinctly identifies data for conformance to product specifications.

CUSTOM PRODUCT DEVELOPMENT AND MANUFACTURING
GWB welcomes projects that assist customers in the development of new products or improvement of existing products. The company resources include scientific personnel in the areas of immunology as well as the physical science disciplines with over twenty years of experience in developing new and improving existing products. The combination of experience and scientific knowledge makes it possible to provide our clients with solutions that meet their project goals both on time and within budget.

1989