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Stipulations Importing Animal and Human Biologicals

Biologicals are pharmaceutical products used in healthcare research, diagnosis and prevention for treatment of diseases. These are collected from live cells or tissues such as sera, vaccine, recombinant products, etc. Basic biologicals such as cells, tissues, serums, blood, and sputum samples are used for potential therapeutic, diagnostics and research applications.

Medical and healthcare research on animals and humans involve the import of biologicals, which needs to comply with certain regulations. Maintaining the safety and efficacy of such products is vital. Regulatory bodies have mandated their prior approval to analyze the quality of imported products. It also keeps a check on the sale and trade of these biological research materials as bio-terrorism is a growing threat to every country today.

Import of Animal Biologicals

Animal biologicals such as animal blood, animal plasma, animal serum, and animal tissues are obtained from a wide variety of species, including animal products. These are collected from larger animals that are anti-parasite and antibiotic. Bio-product collection is also requested from smaller animals from controlled colonies. Trade of veterinary biologicals internationally has always been restricted to certain factors such as:

  • Concerns that the imported animal biological could introduce foreign diseases into the country of import.
  • Import decisions as directed by regulatory authorities like the North American Free Trade Agreement (NAFTA) and World Trade Organization (WTO) must be science-based and transparent. In this context, regulatory organizations must weigh the credibility, validity, and risk-based analysis models prior to decision making.

Import of Human Biologicals

Though the human biological material is no longer a part of a living body, yet individual claims of ownership of these products can raise ethical questions. Today, human biological specimens such as human serum, human whole blood, etc are stored in a bio-repository known as the bio-bank. The need for harmonization of multiple standard procedures for lab practices is necessary as there is no one regulatory practice in place. Import of biological materials requires permission from the authority; however, new rules have eased the import and export of such samples. This will only fasten the transfer process to recipient countries.

New Rules to Relax Import Policies

Research centers and biotech companies can relax as the government has now decided to bring changes in the stringent import policies. It will initiate a hassle-free and time saving way to import and export biological samples. As per the new mandate, the research organization must file a self-certification with the customs authority. It includes a necessary declaration that the applicant organization will follow all the procedures for safe transfer and disposal of biological samples. Only after complying with the import regulations concerning biological research materials can the regulatory body allows the transfer of these products for further research.

Research Bodies Welcome Move

Research experts understand the value of time saving biological transfer of materials such as animal serum, animal plasma, human blood, and more. Biotechnological research organizations are excited about the move brought about by international regulatory bodies. Moreover, these research companies are concerned about complying with the self-certification procedure to get benefited from the new relaxed rules for the import of biologicals. This will not only reduce time spent in sending applications, but will also save money and manpower required with follow-up procurements and obtaining approvals.

Learn more about Innovative Research and our high quality research materials including human, plant, and animal biological, ELISA & Assay Kits, proteins, antibodies, cell cultures, blood, serum, plasma, and more.  More information can be found at https://www.innov-research.com/ or by calling 248.896.0145.

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Human Biologicals Explained

Single Donors give a countless amount of either their blood or its components like plasma, serum, and platelets. Pooled, otherwise random donation occur when two or more humans combine to donate the components of blood.

Components of Human Blood

Human blood is composed of red blood cells, white blood cells, plasma, and serum. The difference between white blood cells and red blood cells is the presence of hemoglobin in the former and absence of it in the latter. Plasma, a yellow liquid has the greatest volume in blood i.e. 55%, while serum has the lowest one.

Plasma and serum are usually used for different tests; however, both are further used for additional purposes. Plasma separation from blood takes more time than the separation of serum. Also, in case of plasma, the division requires anticoagulants.

Pooled and Single Serum

Serum does not have coagulating factors. The serum, a tiny leftover in blood, is collected from single human donors and then pooled under proper scientific regulations. The minimum age to donate is 18. Single Human Serum that contains antibodies is used for the diagnosis and treatment of many infectious diseases as well as immunotherapy.

Pooled and Single Plasma

Pooled Plasma consists of changed plasma, acquired from more than 30 human donors. Pooling is a phenomenon in which plasma that is seperated from human blood is donated by a number of human donors is brought together. There are many companies that purify Human Plasma and turn it into life-saving drugs (that must be prescribed by licensed doctors) for the treatment of cancers and immune disorders as well.

During a plasma aphaeresis donation, the blood is collected by a machine which separates the plasma, red blood cells, platelets, and returns the red blood cells and/or platelets back to the donor.

Human Pooled plasma is used for the treatment of patients who have decreased blood cells. Included in the modern vital drug list by World health organization, fresh frozen plasma is used in hemophilia B. It is also used to treat individuals who genetically lack the components that are necessary for blood clotting.

Pooled and Single Platelets

In case of platelets, Single donation occurs when a single person donates blood, goes through a process of aphaeresis where the machine separates the platelets and sends the blood back to the donor. This series is done several times and the required amount of platelets are obtained from one single donor.

Sometimes it becomes vital to collect blood from many donors. After collection, platelets from each donor are combined for further use. These are termed as pooled platelets. This method is highly effective and fast than pooled donor where one unit of a single donor is equivalent to 6-8 units of pooled donor platelets.

Single donors also have a lesser chance of carrying other components such as Red Blood Cells. They are often collected against any special need that is why they have a smaller chance of getting wasted. Moreover, platelets from single donors can be transfused to any blood group.

Innovative Research is a US based, worldwide distributor of a vast array of animal and human biological products ranging from human serum to cyno monkey plasma. You can find out more about these valuable research materials by visiting our website at https://www.innov-research.com or by calling us direct at 888.660.6866.

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Assortment of Animal Biologicals

There are various kinds of animal biologicals that are collected for different reasons. Some are used to cure diseases while some specimens are preserved for future use. Amongst the various types of biologicals, the ones most commonly collected are animal serum & blood products, raw animal biological products, chicken tissues & organs.

Necessary Conditions to Collect Animal Biologicals

Before the collection of animal biologicals, there are a few conditions that must be met:

  • Animal Biological Collection from a Healthy Organism
  • It is important to confirm that the animal is healthy and free from any kind of contamination.
  • It is vital to remember that specimens should never be collected from sick animals.
  • It is also critical to check everything regarding parasitic contamination as it affects the integrity of the tissue’s sample.
  • After the supervision of antibiotics, biologicals are collected within 21 days.
  • The animal should be free from any kind of stress. Quality of a sample from an animal under stress raises chances for the sample quality to be compromised.
  • In order to study certain diseases like cancer diabetes, endocrine disease, and Alzheimer’s, biologicals are preferably collected from genetically modified animals.
  • It is recommended to collect the samples using methods that cause minimum pain to the animal.
  • Site Cleaning

Health measures must be kept in mind and maintained before and during the procedure. After collection, the place should be thoroughly cleaned. The site must be properly disinfected and proper equipment should be used. The site should be disinfected using 70% alcohol. Used syringes must be properly disposed of.

  • Animal Biologicals That Need to Be Frozen

All specimens/materials collected that are intended to be frozen must be transported on ice to the nearby lab for further examination. In case of risk of virus, it should be frozen in a store where temperatures are maintained under 20-degree Celsius.

Small animals must be stored at a moderate temperature for about 5 hours. For blood sample collections, various chemicals are used that are termed as anti-coagulants; sodium herapin, Sodium EDTA, Alsevers Solution etc. are a few.

Chicken red blood cells are collected from the wings veins of three different chickens and then mixed with anticoagulants. These chickens are housed separately from other chickens.

Use of Forceps

Forceps should be used to preserve small insects.

Collection of Widely used Growth Supplement

The widely used development supplement for cell culture media is fetal bovine serum. It has the highest rate of fast progression of embryonic growth. When used at appropriate concentrations, it supplies many defined and undefined components. These components have shown to satisfy specific metabolic requirements for the culture of cells.

Fetal Bovine Serum is collected in a sterile plastic bag and is allowed to clot. After separation from the clot, it is frozen. The crucial factor is controlling the initial collection to preserve the quality of final serum product, out of which only raw material is approved for production.

Tissue Compilation

Tissues from different animals are preserved using 10% buffered formalin. For longer periods of time they are refrigerated under minus 100 degrees and for shorter periods they are kept at 40 degrees Celsius. These preserved specimens can be used later for long-term issues relating to the health of different species.

Innovative Research is a US based, worldwide distributor of a vast array of animal and human biological products ranging from human serum to cyno monkey plasma.  You can find out more about these valuable research materials by visiting our website at https://www.innov-research.com or by calling us direct at 888.660.6866.