GMP Human AB Serum: Frequently Asked Questions
a. GMP Human AB Serum (Catalog # HABS001-GMP-100ML) is collected from a maximum of sixteen (16) healthy male donors of the AB serotype at FDA-licensed facilities located in the United States of America. Testing of the material is compliant with health requirements outlined by 21 CFR 610.40.
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a. GMP Human AB Serum is Sterility tested per USP <71> and Ph. Eur. 2.6.1 guidelines, along with Endotoxin testing per USP <85> and Ph. Eur. 2.6.14 guidelines, and Mycoplasma testing per USP <63> guidelines. TSE/BSE statement is available upon request.
a. GMP Human AB Serum undergoes Sterility testing per USP <71> and Ph. Eur. 2.6.1; Mycoplasma per USP <63>; Endotoxin per USP <85> and Ph. Eur 2.6.14; Osmolality per USP <785> and Ph. Eur. 2.2.35; pH per USP <791>; Hemoglobin; and a variety of biochemical profiling tests in addition to viral testing.
a. To minimize the presence of reactive antibodies, such as anti-MHC antibodies. In female donors, antibodies may be generated against antigens present on both the father’s and fetus cells during pregnancy.
a. Blood type AB is characterized by the presence of both A and B antigens on the surface of red blood cells. Serum derived from AB blood group donors proves notably advantageous, given the absence of anti-A or anti-B antibodies which minimize immunoreactivity.
a. As opposed to other human AB serum products, which can potentially draw from pools of several hundred donors, each lot is derived from no more than 16 donors. These donors may undergo serial collections. Some customers may find small donor pools necessary to meet regulatory requirements for clinical applications, especially those in Europe.
a. Animal components (like FBS) are not ideal supplements for ex vivo clinical work from a safety and regulatory perspective.
a. Plasma derived. Off the clot (OTC) material is more expensive, harder to source, not easily scalable, and generally not needed to achieve results in cell culture. Plasma derived is treated with therapeutic grade thrombin.
a. The product has an expiration date of 5 years from date of manufacture when stored at ≤ -10 °C. Please refer to the lot-specific Certificate of Analysis.
a. Precipitates are normal for serum and should not impact the performance of the product. The product is filtered prior to bottling. To reduce the chance of precipitates forming, please follow the thawing instructions of the product insert and minimize temperature fluctuations. Skipping a heat inactivation protocol will also reduce precipitates.
a. GMP Human AB Serum is not heat inactivated. The need for heat inactivation is application dependent, and we generally recommend using the product without it. Heat inactivation has the potential to disrupt beneficial components in the serum, possibly leading to reduced product performance. However, use provided heat inactivation protocol if heat inactivation is needed.
a. GMP Human AB Serum is not gamma irradiated.
a. Preclinical or ex vivo clinical use. Not for in vivo or diagnostic purposes.