Researches Involving Human Serum

Human serum is the name given to the human blood which does not contain fibrinogens and other blood clotting agents. The serum is produced by carefully removing the substances mentioned so that the final product which contains red blood cells, lymphocytes, and macrophages is used for research purposes. These researches mainly aim to produce human biological products which can be used to either study the conditions of a disease or produce biological products which can help cure a disease.

There are many organizations and institutes who collect serums and the biologicals contained in it from donations either pooled or individual. For this to happen, they need to have the authorization from FDA in the form of the license which they issue.

How is serum obtained?

As we stated earlier, the serum is collected by FDA licensed health institute which collects blood from the donors.

Based on the research type, the obtained blood is processed according to the FDA virology’s to ensure that each bleed contains human products according to the recommendations. After that, the serum can either be required in its natural unclogged state, or the researchers could want an off-the-clot serum.

In the former type, anticoagulants are added to the serum and also the natural coagulant agents are removed from it. However, in the off-the-clot serum, no anticoagulant is added and it is obtained from the blood that has been allowed to clot immediately after centrifugation.

Having said that, there are numerous researches where few specific components of the blood are not needed. For them, special serums are made. For example, the type AB serum is the one that does not contain anti-A or anti-B antibodies. This serum is used where the behavior of human blood is to be studied in low immuno-activity.

What are some of the researches performed?

The answer to this question can be a long one. This is because for new advancements to occur in the field of health sciences there are numerous researches that are carried out. Each of these requires human biologicals in one form or another. However, generalizing all those researches, they can be broadly put into three categories.

  • Immunohistochemical Staining

IHC or immunohistochemistry is the discipline which focuses on the applications of antibodies to know how a tissue reacts to a certain disease. Immunohistochemical staining is a technique in this discipline which contains the processes involved in studying the behavior of the cells. Due to the disadvantages of the cancer diagnosis and treatment preferences such as hematoxylin and eosin methods and MTT staining, the immunohistochemical staining is employed these days in searching for an effective diagnosis method and a viable cure of cancer.

  • Human Leukocyte Antigen Typing

Researchers use HLA to treat patients who receive a transplant from a donor. HLA are basically proteins which are present on all of the cells in our body. These markers are used by our immune system to recognize native cells. Any foreign bodies that enter our bloodstreamare easily recognized since they do not have the HLA markers. Thus, before or after the donation, the transplanted organ has to be treated with HLA Typing in order to eliminate any possibility of rejection by the body of the acceptor.

  • Researches Involving Cell Culture Media

Normally, these days, all researches that involve humans as a subject as well as an object of the research require human serum or biologicals. The reason why the use of animal sera has been rejected is the fact that under conditions where there is a need to have the cells of the immune system to play a part in the research, only the human sera can provide the researchers with appropriate and targeted research results.

Research and Ethics

From the above discussion, it can be acknowledged that the human biologicals or the human serum have an increased demand for fuelling important health researches around the world. However, before obtaining them, ethical considerations should be implemented.

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.

 

 

The Significance of Platelets in Human Plasma

Have you been to a blood drive lately where you were asked to donate your blood plasma? The human plasma plays a crucial yet sometimes unrecognized job of carrying white blood cells, red blood cells, and platelets throughout the body as the fluid in which they travel. These blood components are indeed essential to body function, but so is the plasma, which makes up about 55% of its contents along with water, salts, and enzymes.

Importance of Plasma

The human blood is a connective tissue that is made up of plasma and formed elements, which are is basically erythrocytes, leukocytes, and human platelets. The main role of human plasma is in the transportation of proteins, hormones, and nutrients to various parts of the body. It also helps in the removal of waste that is deposited by cells from the body, which is why plasma is a significant component in remedying various vital health problems.

In addition to carrying enzymes, amino acids, nitrogenous waste, nutrients, and gases, the human plasma also contain important components such as antibodies, the three major categories of plasma proteins, which are albumins, globulins, and fibrinogen. They are all the most abundant substances in play a cohesive role, including clotting, defense, transport, especially with patients suffering from burns, shock, trauma, as well as creating therapies for other rare medical conditions such as autoimmune disorders and hemophilia. The plasma proteins interact in specific ways to cause the blood to coagulate, and by so doing, it helps protect the body against the loss of blood and invasion by foreign microorganisms and viruses.

Functions Of Human Platelets

Human platelets, on the other hand, are tiny fragments of a large bone marrow cell called megakaryocytes. Even though they are not considered real cells because of how they look, they contain many edifices that are pivotal to halt bleeding. This is because of the presence of proteins on their surface that allows them to stick to each other and on to breaks in the blood vessel wall thus creating a temporary but firm plug to stop excessive bleeding. Human platelets also have the following functions;

  • They exude procoagulants to promote blood clotting
  • They produce growth factors to maintain the linings of blood vessels
  • Dissolve blood clots when they are no longer needed
  • They digest and destroy bacteria
  • Human platelets also emit vasoconstrictors, which tighten blood vessels, causing vascular contractions in damaged blood vessels

Important Roles Of Platelets

Three of the most important roles that human platelets play are vascular spasms, platelet plug formation, and blood coagulation. Which is why some women will experience heavy menstrual bleeding or children will have frequent nose bleeds and bleeding in the mouth and gums due to a platelet disorder or other medical conditions known to cause an abnormal platelet function such as some forms of leukemia, chronic kidney disease, or heart bypass surgery.

Therefore, if you are a blood type AB, which is in demand for plasma donation, you might save a life unknowingly by donating your blood today.

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.

Human Serum Difference in Biological Research

Innovations are happening all around us and the progressive track of technology has enabled us to do so much that were previously considered impossible. From voice assistance to machines that can make decisions on their own, we’ve come a very long way. In the same manner, the innovations in biological sciences has boosted significantly. With better equipment and latest technologies, scientists have been able to unearth minute details of the human body, recreate tissues and synthetic materials. One such significant success in the biological sciences sector has been the extraction of human serum.

Where is Human Serum Used?

Human serum is widely used for various reasons from medical purposes to scientific research. It a useful fluid obtained from human blood after applying certain method of extraction, with useful properties beneficial most significantly in biological research.

The human serum is extracted from blood plasma after a factor fibrinogen and other similar clotting factors have been removed from it. This serum is most commonly used while researching immunity of human body and devising medicines and supplements that can boost the immune system. Another use of human serum includes usage in cell culture media, that is, synthetically growing cells and studying bacteria growth and resistance to medicines. Human Serum is more effective and provides a more feasible environment for cell growth in contrast to animal serum. A more particular usage is while working with immune cells like lymphocytes and macrophages.

Human serum can be extracted from individuals or pooled donors of serum which can be classified on the basis of sex, age and disease states, based on the requirement of your research.

Types of Human Serum:

There are different kinds of serums which differ in nature based on the use. For instance, off-the-clot serum is extracted from blood which has been left to clot spontaneously after the process of centrifugation. Note that, this doesn’t contain anticoagulants.

Another type of serum, known as type AB serum is used while studying immunoactivity. The reason for so is that it doesn’t contain in itself any interfering anti-A or anti-B antibodies that skew the observations of the experiments performed.

Complement human serum involves proteins which get activated on sequential basis when the antibodies in the blood get the chance to interact with the respective antigens. These proteins degrade very quickly if the storage and preparation methods are inadequate. To ensure optimal quality of the serum, it should be collected fresh and stored in cold temperatures.

Proper Care and Storage

We take special care in preparation and storage of human serums, because we understand how important it is for biological research. Accuracy of your research depends on the quality of the product and we ensure that we deliver the best. For more information and queries regarding our products, feel free to get in touch with us through email or our hotline number.

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.

Controversy Surrounding the Collection of Fetal Bovine Serum

Bovine is an animal that is related to the cattle group including cows, heifer, bull, bullock, calf, ox, or bison.  Fetal bovine serum, also known as fetal calf serum, is harvested from a bovine fetus taken from a pregnant cow during slaughter by means of a cardiac puncture without any form of anesthesia.  Fetal bovine serum is a blood product that is widely used in laboratories to promote growth medium, including biotechnology research, vaccine production, cloning and in vitro fertilization.

The Importance of Fetal Bovine Serum

We can thank fetal bovine serum, FBS, for its latest role in creating a more sustainable product that does not require the hassle and waste of cattle production.  A plan-based food company has recently made public its plans to bring lab-grown meat made from the blood of cow fetuses into circulation soon.

Aside from the moral concern surrounding the collection of fetal bovine serum, because needless to say that the fetus, which remains alive during the process to ensure blood quality, has a needle inserted into its heart, there are several scientific and technical problems that exist now regarding the application of fetal bovine serum in cell culture.

While the extraction process may seem inhumane, animal biologicals have been meticulously tested by pharmaceutical companies as sources of drugs to the modern day medical science and even used in the testing of drugs, vaccines, various biologics, and medical devices.

Why Use Fetal Bovine Serum?

Fetal bovine serum is commonly used because of its high content of embryonic growth promoting factors, but as a matter of good research practices, some scientists and researchers have questioned the potential suffering caused to the calf during the extraction process of harvesting of blood from the bovine fetus and are now looking for other ways to develop serum-free alternatives.

It is estimated that around 700,000 liters of fetal bovine serum were sold in 2008 to collectors, manufacturers, and end users who belong to the International Serum Industry Association that prides itself on the safety and safe use of serum and animal biologicals.

This would obviously be a hard pill to swallow for many animal welfare enthusiasts because when animal testing is done to support bids for medical products regulated by FDA, manufacturers, or sponsors are required to follow FDA’s regulation whether it’s a frowned up process or not.

A Positive Look On The Research

Looking at this issue on a positive note, animal testing has proven beneficial not only in promoting very important research programs but also in saving countless lives. Research shows that bovine fetus serum is taken from pregnant cows which have been sent to the slaughter house for reasons such as crippling lameness or from the simple fact that they are bred for their beef purposes.

The cardiac puncture process used to harvest bovine fetus serum, which is performed by inserting a needle between the ribs directly into the heart of anaesthetized fetus, may seem inhumane, but it is primarily used because it minimizes the risk of serum contaminations with micro-organisms from the fetus itself, and its environment. The calf is then quickly removed and cleaned to live a healthy life.

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.

Research Involving Animal Serum

Animal testing has been an integral part of medicine to see how a given medical procedure will behave in the animal before carrying it out on humans. Although the application of research on the human is under strict control requiring high-level committee approval, humans as the test subject in biological research is a practice towards finding lasting solutions to human-related diseases and ailment since the beginning of quests into animal-related health solutions.

What is animal research?

Animal research defined is the research carried out, either to perform research for the benefits of humans or animals to understand the basic biology, or to understand basic biological nature of the targeted animal subject.

What is the purpose of animal research?

The purpose of animal research, therefore, stems from the need to find life-enhancing medical answers to human and animal medical issues to develop and understand the effect of chemicals on humans about tackling health challenges. Animal biological research material looks into new ways to understand diseases and how to carefully regulate the use of serum, e.g., monkey serum, in the control of human ailments.

One of the steps scientists take to carry out research involving animal is to identify the target part of the body to receive the serum; this is often a protein where the new medicine will work. The designated target area in the tissues, cells, animals, and human then studied to understand how the application of such research material will perform on such part of the animal.

Who performs animal research?

University health centers and a wide range of medical, scientific and pharmaceutical organizations and biotechnology companies and several other health and medical research groups and government are involved in carrying out research involving animals. The objective of such research will agree with what was discussed earlier in this article.

The use of animal biological research material such as monkey serum and others including microbes, cells, recombinant DNA, biological fluids, biological toxins, etc. on human and animal subjects for research purposes must get approval from the appropriate committee before application. This is because the oversight body has ethical obligations of ensuring the use of animal subjects in research is done responsibly. Therefore, there are established procedures in which animal biological research material are treated and identified in the approval appendixes to show the intended purpose before they are used.

Therefore, all teaching exercises and research studies relating to the use of biological materials including human cell lines, recombinant DNA technologies, microorganisms, human embryonic stem cells, viral vectors, viruses, and nano-particle based nucleic acid or drug delivery systems require approval from the relevant approving body before such test or research can commence. The purpose here is to protect animals and humans who are deemed to enjoy inalienable rights, but their approval as a research subject is done for the life-enhancing need to protect the majority of animals and humans whose lives may be endangered if such research is not approved to find best and lasting solutions to potential medical problems.

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.

Ethical Considerations on Using Human Biologicals in Research

Human whole blood is a combination of human red blood cells (RBCs), various other cells, and plasma. For various experiments and research projects, these human biologicals are needed in order to come up with the research objectives and to provide a solution for any problem that is prevailing or that concerns the human body in general.  However, no matter how much important is any research. There are ethical issues that need to be addressed before going further into the research.

Why are these considerations important?

Ethical considerations govern the process and are needed for the betterment of the research and of the society as well. These considerations are important because they allow us to do something that is right and use our resources for the better tomorrow of the human race. There have been many mishaps in the past where researchers were not bound to follow these ethical rules and as a result, they committed some serious moral crimes.

The benefit of ethics is to teach every researcher that the value of an animal, human being or its biologicals is far greater than any experiment.

There are other benefits also.

  • Ethical considerations promote healthy experimentations where the researchers can find moral satisfaction.
  • Researchers governed by these rules are always supported by the general masses.
  • The test subjects involved find collaborating with each other fruitful and easy.
  • The research can be further extended into the future without a problem.

Why was there a need for such considerations?

The need for such considerations came because of the unethical experiments that took place in the past. The researchers such as the Tuskegee Experiment which used around 600 men who had contracted syphilis; Milgram’s Obedience Experiment which was abusive to the psychology of the test subjects; and Zimbardo’s Prison Experiment which led the subjects to violence and dangerous behavior are the reasons we have these ethical rules today.

How are they implemented?

One of the organizations which implement the ethics is National Commission for Protection of Human Subjects of Biomedical and Behavioral Research. Also, the Office for Human Research Protections is also doing a good job in preserving the ethics.

In numerous colleges and universities, certain communities like Institutional Review Boards (IRBs) are formed to check if the ethical codes are being applied.

What are the considerations?

Proper issues and considerations are well addressed in the UniSA online ethics system.

According to them, these considerations are:

  • The research that is being done should have value for the humans.
  • No researcher should expose his health to any kind of harm in the research.
  • The subjects’ consent should be the top priority.
  • The data or the results of the research should be handled with confidentiality.

The human biologicals of the human whole blood, only the human red blood cells, or any other biologicals should be treated under these ethical considerations at all cost not just for the health of the research but also for that of the humans in general.

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.

 

 

The Research Process Involving Human and Animal Biologicals

What Are Biologicals?

Biologicals can be defined as pharmacological products utilized in healthcare research, diagnosis and prevention for treatment of diseases and observation of change in behavior of several different cells under different circumstances, when they come in come in contact with various biological agents. Biologicals are gathered from live cells or tissues like sera, vaccine, recombinant products, etc. and are used for potential therapeutic, diagnostics and research applications.

Medical and healthcare research, be it on animals or humans, requires the utilization of biologicals. Biologicals can be originated from animals such as animal blood, animal plasma, animal serum and animal tissues. Animal biological products for research purposes can be obtained from a wide range of animal species. Although, the human biological specimens such as human serum, human whole blood, etc., that used in research, originate from human bodies but are no longer a part of a living body. Human biologicals specimens and animal biological materials are at the core of basic research. Recently, a lot of work is being done around human and animal biologicals due to the enhanced growth rate that they provide for various cell culture mediums.

Use of Biologicals for Research Purposes:

Biological research encompasses several individual yet related, contained yet diverse fields of experimental biology, such as biotechnology, cell biology, cancer, evolutionary biology, genetics, genomics, immunology, microbiology, molecular biology, plant biology, physiology, stem cell research and systems biology. Whatever the subject of research, biologicals are essential for carrying out all sorts of biological phenomena.

Processes That Utilize Biologicals:

There can be several processes involved when it comes to biological research, for instance;

  • Creating new functions for proteins or RNA by manipulating the approach for choosing molecules with the same properties from a varied population.
  • The integration of cells into organs and tissues by medium and indicating molecules.
  • The Study of individual cells’ processes. This would include cell division, signal transduction and motility, organelle inheritance and biogenesis.
  • Studying the genetic, biochemical and molecular biological systems available for microorganisms so as to make them achieve particular desired ends.
  • Understanding the use of different molecular architectures to perform chemical reactions that are central to life.
  • Identifying molecular mechanisms underlying stem cell renewal and differentiation programs.
  • Investigating the roles of stem cells in regeneration along with the potential of stem cells for disease modeling and regenerative medicine.

We, at Innovative Research, realize how important it is to understand the value of time that can be saved in the transfer of biological materials such as animal serum, animal plasma, human blood, and more. Therefore, we provide you with best quality human biological research products that work perfectly with all cell cultures, their processing and manufacturing, by promoting and enhancing the cell growth rate. Along with human biological research products, we are also provider of animal biological research products. At Innovative Research, we always have fresh stock available and ready to be shipped to you as soon as you place your order. More information can be found at https://www.innov-research.com/ or by calling 248.896.0145.

 

The Significance of Harvesting Fetal Bovine Serum in Animal Biologicals

FBS, otherwise known as, Fetal Bovine Serum is fetal serum from a calf and is blood that is fractioned and remains once the blood is naturally coagulated and separated from the red blood cells by centrifugation. Fetal bovine serum is a product that is utilized in laboratories for research purposes. It is a blood product which surpasses cell culture testing standards and, therefore, is extensively used to promote growth medium.

First Step in Process

FBS is a dairy industry by-product. Just like the majority of other animal serum utilized in cell culture, Fetal Bovine Serum, is created from blood collected from commercial slaughterhouses. The first step of FBS production is the harvesting of blood from a bovine fetus with the help of a closed and isolated selection system. A cardiac puncture is performed on a calf’s fetus during slaughter and the blood is drawn from the bovine fetus after the fetus is removed from cow that has been killed. The blood is refrigerated so that it will clot.

Step 2- Filtration

A process known as centrifuge is then utilized to remove the fibrin clot and the remaining blood cells from the clear yellow (straw) colored serum and, finally, the clear serum is separated from the slotted blood cells. The second step involves filtration which employs a filtration chain with triple sterile 0.1 micrometer membrane filters. After being processed, the sterilized fetal bovine serum is subjected to strict quality control testing by a reputable commercial serum supplier. If the serum clears the quality control testing, it is supplied with a detailed Certificate of Analysis.

Significance of Fetal Bovine Serum

FBS is the most commonly used serum-supplement for the in-vitro cell culture of multi-cell organisms. The reason behind its extensive use is the serum’s low level of antibodies and its high content of embryonic growth promoting factors, which helps the serum to develop versatility in various cell culture applications. There are so many fields in which the cell culture medium growth is considered of great importance, like biotechnology, vaccine production, cloning and in-vitro fertilization. FBS when used in proper concentrations can satisfy specific metabolic requirements for the culture of cells and help it grow because of its high content of hormones, carrier proteins and macromolecular proteins. The embryonic stem cells are transferred, by FBS, into the culture medium which leads to growth of the cells.

Moreover, many vaccines available in the market today are produced using FBS for cell culture growth medium. For instance vaccines that protect against viruses utilize fetal bovine serum. Recently, several experiments are being conducted in an attempt to clone animal tissues and within the field of biotechnology; FBS is often employed in these experiments.

You will find that FBS is offered by several manufacturers in the market, and since cell growth in in-vitro is highly sensitive, customers prefer to check specific batches to ascertain for aptness for their specific cell culture under research. Here, at Innovative Research, we make sure that we provide you with only the highest quality fetal bovine serum and other products that you may need for research purposes. We ensure that we price our products affordably, without compromising on quality.

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.

The Importance of Human Serum

The human blood is comprised of several important parts all with different purposes. Human blood is made up of plasma, human serum, red blood cells and white blood cells. Red blood cells are the cells that carry oxygen to all parts in the body while white blood cells are the cells that fight against diseases and foreign bodies.

Plasma and human serum are similar but the greatest difference is the clotting factors. Fibrinogen is a substance that is essential for blood clotting to take place. When human serum and plasma are separated from the blood, plasma retains the fibrinogen element while human serum constitutes the part of blood without fibrinogen.

Human serum thus constitutes water which is dissolved with hormones, minerals, proteins and carbon dioxide. Human serum is an important source of electrolytes.

Why is human blood split up?

When an individual donates blood, this blood is separated into different parts so that it can be given to different patients with specific needs. Blood is separated into red blood cells, white blood cells and proteins. Blood proteins constitute serum albumin, globulins, fibrinogen, and plasma. For instance, if a patient is suffering from liver failure or has problems with blood clotting, he may receive blood plasma which has clotting factors. The human serum is the remainder of blood after the clotting factors of fibrinogen have been removed and it contains proteins such as albumin and globulins.

Functions of human serum

The human serum is a circulating carrier of exogenous and endogenous liquids in the blood. It allows substances to stick to the molecules within the serum and be buried within it. Human serum thus helps in the transportation of fatty acids and thyroid hormones which act on most of the cells found in the body.

Thyroid hormones are essential to the proper development and functioning of the body because they help to regulate bone growth and maturation, carry out protein synthesis and increase the body’s basal metabolic rate. Human serum also helps transport other hormones which are fat soluble.

Due to its unique role as a circulating carrier, human serum is used in the protein binding of many drugs to facilitate drug distribution within the body. Human serum is used to distribute antibiotics in the body and albumin allows the curable substances in the antibiotics to be bind and carried out throughout the body.

The human off-the-clot serum is the serum that has been allowed to coagulate naturally after collection and has not been exposed to any anticoagulants. The human off-the-clot serum is ideal for metabolic studies because it is available in the original transfer packs straight from individual donors.

Human AB serum is collected from type AB donors and it lacks antibodies against blood type A and B antigens. Human AB serum is used in cell therapy applications and transplantation and tissue engineering.

Human complement serum is a complex mixture of serum proteins which are activated when antibodies in an immune animal interact with corresponding antigens. Human complement serum is used for in vitro research only and biocompatibility experiments.

Innovative Research

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.

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.