Production and processing methods of human AB serum

Human AB serum is vital within the field of biological research. It offers vitamins, nutrients, and necessary growth factors in cellular culture, and reliable controls in vitro diagnostics. This article explores some of its respective production and processing methods.

Production and processing methods of human AB serum

Image Credit: BioIVT

Base material

The base material for human AB serum is collected from healthy male donors with the blood type AB—one gender is used to lessen variation in the final product. The AB blood is used as AB donors have both A and B antigens on their red blood cells and therefore lack blood group antibodies, guaranteeing that the serum will not react with other blood types, further diminishing immunoreactivity for researchers.

Typical lots of human AB serum are produced from between 150 and 250 donors and pooled, but custom batches with fewer donors are also used. BioIVT can produce human AB serum lots of less than 10 individual donors or generate lots with single donors.

Production methods

Viral testing research use only (RUO) grade

AB Serum can be produced through two methods. In plasma-derived human AB, the serum is generated from a donor source plasma, which is then plasma is defibrinated. This is where thrombin, from either a human or bovine source, converts fibrogen into fibrin, thus turning the plasma into serum.

In contrast, off-the-clot AB serum is produced from donor whole blood, and the blood is allowed to clot naturally. The serum is taken from the resultant fractionation, allowing the product to retain various growth factors and compounds found in whole blood, without additional processing compounds. Therefore, this method yields a product that is most like the normal human material.

Off-the-clot serum is produced with more donors per batch, making processing more complex. In contrast, plasma-derived serum uses a smaller number of donors and can be produced with recallable donors, strengthening its availability and manufacturing timelines.

Viral testing

To guarantee safety, each batch of the human AB serum produced by BioIVT is tested for the following viral pathogens:

  • Syphilis
  • Human immunodeficiency virus (HIV) 1 and 2 (virus and nucleic acid)
  • West Nile virus
  • Hepatitis B (surface antigen and nucleic acid)
  • Hepatitis C (virus and nucleic acid)
  • Human T-cell lymphotrophic virus (HTLV) I/II
  • TSE/BSE
  • Chagas

Additional viral testing is always available to meet regulatory standards

Good manufacturing process (GMP) grade

The designation of GMP grade for human AB serum does not just come from a certification. GMP is a process based on a set of optimized protocols with enhanced oversight via source material collection, production, and processing, which can later be accepted by regulatory and quality agencies.

It also demonstrates a facility’s compliance with personnel training, environmental monitoring, and equipment validation.

BioIVT’s GMP-grade material is made following the same protocols and oversight as its RUO material, but it offers additional documentation and testing for:

  • Parvovirus B19 (plasma-derived only)
  • Hepatitis A (plasma-derived only)
  • Hepatitis E
  • Hepatitis B — core antibody

For the manufacture of any autologous or allogenic cell therapies, BioIVT’s GMP-grade human AB serum is a premium cell culture supplement.

Additional processing

Although RUO and GMP-grade AB serum are sterile filtered, there are further processing methods that can be used depending on a client’s specific need.

Sterilization

There are various methods of sterilization. Traditionally, the serum is sterile-filtered using a 0.1 μm filter, but filter trains of various pore sizes can also be used. BioIVT’s serum is serial-filtered down to a final filtration step of a 0.1 μm filter to optimize the quality of the product.

Heat inactivation (optional)

Heat inactivation is achieved by exposing the serum to a high heat for half an hour and then allowing it to return to room temperature, disabling complement activity in the serum without affecting growth factors.

Gamma irradiation (optional)

Human AB serum can be further treated using gamma irradiation, specifically addressing viral inactivation, and increasing the suitability of the manufacturing of cell and gene therapy.

Applications

Human AB serum is rich in growth factors and is capable of improving expansion rates of therapeutic cell types (such as chimeric antigen receptor T cells).

For in vitro diagnostic studies, it is an exceptional negative control that allows researchers to identify if the disease state or condition being monitored is accurately identified.

It can reduce the time needed to reach patient doses, which is particularly important in autologous therapies where cells may have been exposed to several chemotherapy rounds, meaning lower cellular division.

About BioIVT

BioIVT, formerly BioreclamationIVT, is a leading global provider of high-quality biological specimens and value-added services. We specialize in control and disease state samples including human and animal tissues, cell products, blood, and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research and the effort to improve patient outcomes by coupling comprehensive clinical data with donor samples.

Our Research Services team works collaboratively with clients to provide in vitro hepatic modeling solutions. And as the world’s premier supplier of ADME-Tox model systems, including hepatocytes and subcellular fractions, BioIVT enables scientists to better understand the pharmacokinetics and drug metabolism of newly discovered compounds and the effects on disease processes. By combining our technical expertise, exceptional customer service, and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in ELEVATING SCIENCE®.


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Last updated: Feb 1, 2024 at 7:53 AM

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