FDA's role regarding biological products

Biological products represent an advancement of the medical science and research world. Also known as biologics, these substances can be utilized in the place of natural substances like enzymes, antibodies, or hormones in human bodies. Some individual have normal range of production in their human bodies whereas some have scarce amounts is excess levels of production. However, both conditions can lead to critical health issues. As these substances can replace the natural substances to carry out all the necessary functions of the human body, they are extracted from individual and administered to the other person in the whole form or in a synthesized form like a medicine or drug.

The accuracy and quality of these substances are very important to maintain. The person who is giving and also the body which is collected will be affected by the type of the substance. To check and assure the quality of these Biological Products, Food and Drug Administration (FDA) an agency in the United States of America imposes a certain test and examination criteria before qualifying the product to be administers or utilized. All the biological units must test and qualify with these regulations in order to avoid health complications. However, there are certain kind of products that FDA approves for medical use and for clinical researches like Human Blood Products, allergenic extracts, human tissue, cells and genes. These substances are available in many different formats and states at the biological centers.

The role of the FDA with respect to formulating Biological Products is not just limited to certain rules and regulations. FDA also reviews new samples and new indications and usage of already approved items in order to get them on the market for the treatment of known diseases whenever required. It also helps provide the public with information to promote the safe and appropriate use of biological products and prevention against threats of emerging infectious diseases. It also highlights the uses and different disease states available in these samples.

Once the products are being approved by the federal board these samples are available in the market for medical and individual use. However, some items are only delivered in exchange of the physician prescribed note. Today, many biological centers are available that offer such items on the customers demand. One can get access to any kind of samples from minute samples to bulk amounts. There are many disease states also available that are very much in demand for creating various vaccines and medical therapies today. You will be provided with the approval certificate to assure the quality of the product that is being delivered to you. You can be rest assured for the source from which the following product is being collected.

The most common product being the Human Blood Products contributes much to the present medical world and scientific research. While extracting of such items with zero risk of transmitting infectious disease may not be possible, the blood supply is safer than it has ever been. As biological products, blood and blood products are likely always to carry an inherent risk of infectious agents. Therefore, zero risk may be unattainable. The role of the FDA is to drive that risk to the lowest level reasonably achievable without decreasing the availability of the resource. These substances are considered as the miracle substances and are proving to be very useful in the treatment of various chronic immune deficiency diseases across the globe. These substances are also proving to be very helpful in the medical researchers to a greater extent in discovering treatments for many uncured diseases and medical states. There are many more benefits associated with them yet to be discovered.

Health concerns for the plasma donors

Donating Plasma comes along with both pros and cons associated with it. However, donor’s health is the major area of concern that all the Plasma Donor Locations look for. Plasma being the liquid part of human blood plays a prominent role in carrying out all important body functions and keeping the human body healthy and fine. So, when this substance is being extracted from the human body it affects the health of the person who is giving it to some extent, though the observed effects are not too serious. The person may feel little dizzy or sleepy post the donation.

Generally, the human body replaces the lost substance within approximately 48 hours of Donating Plasma, but only if the person follows a healthy diet with adequate amount of fluid intake. It’s very important that the donors must follow a diet that meets the recommended daily requirements for protein, iron and other important minerals that help the humans to keep their body healthy and stable. Only healthy individuals are permitted to donate.

Some of the dietary requirements one must consider before going for Donating Plasma are as follows:

·         The donors must include proteins rich foods such as cheese, meat, poultry, fish, eggs, nuts and beans in their intake.

·         They should also eat foods rich in iron such as tuna, eggs, nuts, beans and lean red meat to help ensure that iron levels are sufficient in their body.

·         They must always remember to stay hydrated by drinking plenty of water or juices the day prior to and the day of donation as well.

·         They must avoid alcohol and caffeine intake.

·         They must take plenty of sleep before going or the donation.

A person’s protein level is tested each time they visit Plasma Donor Locations to give their donations. Apart from this the hemoglobin levels are also tested prior to the donations. If the obtained results are out of the acceptable range set by that particular place, the person will not be permitted to donate.

Typically, each country has mandated certain requirement criteria for Donating Plasma. In order to get eligible for donating in that particular geographical location the person must fulfill all their requirements and policies. In the United States, federal regulations state that an individual may donate two times in a seven day period, with a minimum of two days in between donations. However, apart from this there are certain other regulations that are being implemented commonly by many countries. According to such rules the donors must be at least 18 years of age and weigh at least 110 pounds to get eligible for giving donation.

All the individuals looking for donating must also pass two separately administered medical examinations like medical history screening and testing for transmissible viruses before their samples are collected. The U.S.A and most of the western countries require this pre donation physical examination, including medical history questions, tests for transmissible viruses such as Hepatitis B and C and HIV, total protein levels and hemoglobin levels to allow the person to become eligible for Donating Plasma.

Apart from this, the Plasma Donor Locations must be certified and must carry out donations in a highly controlled, sterile environment by professionally trained medical staff only. Also, all the collection equipments must be sterilized and used only once, for eliminating the possibility of transmitting any viral infection. However, the age requirement and other regulations may differ in some U.S. states and other nations around the world. Therefore, it is important to check your state eligibility requirements for donation before visiting any of the Plasma Donor Locations.

Medical applications of Platelet Rich Plasma

The human body has an extraordinary capability to heal and reconstruct itself. Generally growth of new tissues in the human body is carried out by stem cells and is stimulated by various growth factors and hormones. Human Blood Plasma is also one of such substance present in human blood that can help the human body to restore and reconstruct itself along with acting as a firewall in protecting your body against various external attacks and diseases. This liquid part of the blood works wonders when present within the body in adequate amounts and also when synthesized into medicine formed by collecting it through Plasma Donation.

The development plasma applications in the past few years have given rise to growth of plasma medicines in an innovative field of research showing great potential benefits. In dermatology, new horizons are being introduced by the use of Human Blood Plasma products that provided favorable treatments for various concerns like wound healing, tissue regeneration, therapy of skin infections, and many more skin related diseases. There are numerous treatments that are developed using this miracle substance and have wide applications associated with each.

Platelet Rich Plasma (PRP) is an emerging treatment in today’s advance medical world known as Orthobiologics, which refer to science of growth factors and proteins that are naturally found in the Human Blood Plasma. Platelet rich plasma is the blood plasma that is a naturally occurring component of your own blood and is enriched with a high concentration of platelets in it. This concentrated source of platelets also contains several different growth factors and other cytokines that stimulate healing of bone and soft tissues in the human body. It recreates the entire tissue in the human body when used externally by various medical innovative procedures. Also, it can be used as an aid during minor accidents and bone fractures.

In humans, PRP has been investigated and used as a clinical tool for various types of medical treatments like nerve injury, osteoarthritis, cardiac muscle injury, bone repair, regeneration plastic surgery, oral surgery and many more to list. PRP has also received high consideration in the popular media as a result of its use in treating sports injuries in professional athletes. In dermatology, PRP has a wide range of applications as it encourages skin rejuvenation by stimulating the growth of collagen and improving blood supply to all the skin tissue, both of which are important factors in anti aging therapies. Nevertheless, skin tone and texture will be improved with PRP application. It may take 3- 6 weeks to show the desired results.

Plasma application in dermatology is not limited however. Some among the wide range of PRP applications include treatment of acne, scarring, alopecia (especially in women), skin rejuvenation and tightening around the eyes (for thin crepe like skin and fine lines), wound healing, disinfection or sterilization, post pregnancy skin laxity and therapy of various skin infections or tissue regeneration. PRP collected from Plasma Donation and processed is considered as a miracle substance in dermatology and cosmetic medicine development. It has been used over the last several years as an effective treatment in various surgical and medical fields.

However, each person is unique and responses to PRP medications will vary, though adverse reactions are rare to account. Using topical anesthetic cream before injecting the PRP can help to combat the side effect. You may anyhow feel a tingling sensation after the procedure and there may be redness, slight swelling and bruising observed on your skin. These symptoms will however soon disappear. Consulting a dermatologist prior to any such PRP application is strictly advisable.

Serum globulin electrophoresis process

Serum globulin electrophoresis is a laboratory test that is carried out to examine a specific type of protein in the human blood called as the globulins. The globulins are a family of globular proteins that are mostly produced in the liver and also some of them are formed by the immune system of the human body. These proteins have a high water solubility level and come in different sizes. These Serum Globulins help the humans in the proper functioning of the various vital body functions and also to safeguard the body against various diseases and infections. These substances are the important constituents of human blood.

The serum globulin electrophoresis method is carried out by collecting blood samples from different Serum Donor Locations and performing needed tests and examinations on the donor samples. When the blood samples are collected the blood is kept for clotting so that the liquid portion of the blood called serum is obtained. Once the serum is collected this laboratory technique called Serum globulin electrophoresis is carried out. In this method the collected serum is placed on a specially treated paper containing agarose gel on it that is usually used to separate macromolecules and their fragments. Now this paper along with the serum placed on it is exposed to an electric current. The proteins present in the serum move on the paper and form bands indicating the amount of each protein fraction due to the electric charge. Here all the serum proteins are separated and five major fractions are formed. They are serum albumin, alpha-1 globulins, alpha-2 globulins, beta globulins, and gamma globulins. They also include various types of antibodies such as immune globulins (Ig) M, G, and A.

This test is performed to look at various globulin proteins present in the human blood. Identifying the types of globulins by Serum globulin electrophoresis can help diagnose certain disorders and acute medical conditions. The separated serum proteins can be further used to synthesize various vaccines, therapies and medicines that can help people suffering various chronic diseases.

However, the reports obtained from this test will also identify the amount of globulins proteins present in the individual human body, as an excess and scarce level of proteins can lead to many medical disorders in the individual. Some of the conditions that are generally traced with increased gamma globulin protein levels are chronic inflammatory disease like rheumatoid arthritis and systemic lupus erythematosus, Hyperimmunization, Multiple myeloma and many other acute infections. In such conditions the separated proteins can be utilized either by transfusions or medical substitutes formed by these substances.

Here are few concerns associated with this Serum globulin electrophoresis method. The donors must not intake any food 4 hours prior to the test and must avoid drug intake if any as these products may affect the test and produce inadequate reports. Also, the donors that are giving their samples at Serum Donor Locations may experience little pain or a stinging sensation as the blood is usually collected using a syringe. The pain experience may differ from individual to individual. The medical staff present at the Serum Donor Locations will however take care of this concern as minute fault can leave the donor in many critical conditions like excessive bleeding, Infections and also fainting at times. The medical staff must be professional in both collecting the blood samples as well carrying out the entire process as little misconceptions can leave faulty reports.