HUMAN AB SERUM FAQ
Most Frequently Asked Questions and Answers About Human AB Serum
Human AB serum is collected from healthy volunteer male donors of the AB serotype at FDA-licensed facilities in the United States and collected in compliance with health requirements established by 21CFR 640, subpart G.
The converted serum is routinely screened for the presence of animal contaminants. This is performed by DNA analysis.
Human AB serum is collected from healthy volunteer male donors of the AB serotype at EU-registered facilities. The material is CE-marked and ANSM-approved IVDMD. Please note that in France some donations are made for purely non-therapeutic purposes. In these cases, the age of the donors can be significantly higher than standard donations and also transplanted/transfused donors may be selected to donate.
No animal-derived ingredients (ADI) are used in the production of French-origin Human AB serum. The manufacturing process does not use any ingredient of animal origin.
The off-the-clot serum is collected from the blood that is allowed to coagulate naturally after collection. It has not been exposed to any anticoagulant. The plasma-derived serum is produced by defibrinating pooled human blood collected in the presence of bovine thrombin. The plasma-derived serum is generally more economical and popular than the off-the-clot product. Both Off-the-clot serum and plasma-derived serum are available in both pooled lots and individual transfer packs from specific donors.
Human AB serum supplied by LSG is suitable for research, diagnostic and further manufacturing purposes. Full details as to the collection and processing of human AB serum are available on request. Specific batches of serum may be subjected to additional viral testing, as required. LSG is very happy to discuss specific batch and collection requirements to meet individual regulatory requirements.
Human AB may be supplied in any bottle size e.g. 1 litre, 500 mL, 100 mL, 50 mL, 25 mL, as required, including bottles fitted with septums for the aseptic removal of serum. Human AB serum may also be processed into single-use bags with tubing sets to meet individual production requirements.
Each batch of Human AB serum is tested to ensure freedom from bacteria, fungi, yeast, and mycoplasma (M. pneumonia, M. hominis and M. salivarium). Batches are also tested for the ability to support the growth of specific cell lines. In addition, each batch is also tested for standard parameters. These include endotoxin, pH, osmolality, protein content, albumin, IgG and haemoglobin levels. Details for each batch are supplied on the Certificate of Analysis (COA).
All donor units that form each batch are tested for HBsAg, anti-HCV, anti-HIV1 and 2, HIV-1, and Syphilis. Additional viral testing on both individual donors and pooled material is available to meet current regulatory standards for further manufacturing.
Each batch of Human AB serum is tested for the absence of bacteria, fungi, yeast, and mycoplasma. Our Human AB serum is also sterile filtered to either 0.1 µm pore size-rated filters (US Origin) or 0.2 µm pore size-rated filters (French Origin). Results of microbe testing of each batch of serum are supplied in the COA. However, please note that sterility is not guaranteed after opening. The use of aseptic techniques during handling is recommended.
At one time, heat inactivation was considered necessary because of concerns over the presence of contaminants in serum. However, the process of heat inactivation is known to degrade valuable biomolecules, such as growth factors, vitamins, and amino acids. Many protocols still call for the serum to be subjected to heat treatment prior to use without consideration as to whether it remains desirable. Should it be required, LSP can provide heat inactivation as a custom processing option.
Yes. We offer samples of Human AB Serum for testing prior to the selection of a suitable batch. The typical sample size is 25 mL and reservations are held for a period of four weeks, pending evaluation.
The deferral time for any transfusion patient to stop donating blood products is 12 months. After this time, these donors can return to donating blood, serum or plasma. Transfusion grade collections don’t allow for transfused patients to donate. However, only some sites collect “transfusion grade” serum while others don’t. This means that blood from transfused patients can be present in material pooled from a number of different sites.
In France, it is permitted for people who have received blood transfusions to donate blood for non-therapeutic applications
HLA antibodies are not naturally occurring and can only be acquired by pregnancy, transfusion of blood products or transplantation. Therefore, for a donor pool of un-transfused male donors with blood group AB, provided the donors are healthy, you can expect a very low incidence of HLA antibodies.
Depending on your specific application, you would need to use serum from non-transfused patients if it is important that the serum you receive is HLA free.
Also see the question: Can donors who have received blood transfusions, donate blood for Human AB Serum collection purposes?