All You Need to Know About Radiolabeling

All You Need to Know About Radiolabeling

All You Need to Know About Radiolabeling

Radiolabeling plays a key role in environmental case studies as well as drug development and research. Thanks to radiolabeling, scientists are able to monitor the breakdown or movement of target molecules. With this process, drug researchers are able to track any new drug in terms of how it gets metabolized as it moves through the body. To help achieve this, isotopes of the same atom are used to replace atoms in the target molecule.

In a nutshell, radiolabeling allows scientists to ‘tag’ molecules using radioactive isotopes. The molecules are easily traceable using imaging techniques after carbon isotopes like C14 replace carbon atoms in a given molecule. Though it is possible to trace these isotopes, they don’t interfere with the normal functioning of the molecule under study. Keep in mind that there are several ways to go about radiolabeling using various radiolabeled compounds. The most common radiolabeled compounds include sulfur-35 (35S), tritium (3H) and carbon-14 (14C labeling).

Carbon 14

Carbon-14 is the most preferred radiolabeled compound because it’s able to generate duplicate elements by substituting carbon atoms. Note that the use of carbon for scientific research is not something that started in the 21st century. You might be surprised to learn that the physicist Willard F. Libby discovered radiocarbon dating way back in 1946. Carbon is present in most drug molecules today and this is why it easily offers radiolabeling sites and better stability than other radioisotopes.

Specifically during storage, stability is a factor that cannot be overlooked when using radiolabeled compounds. Now that carbon-14 has a long half-life, researchers don’t worry much about decay during long and extensive studies. In general, carbon-14 is a highly versatile compound whose production can be customized during GMP synthesis. For effective and safe drug production, C14 has to be part of the equation.

GMP Standards and C14 Radiolabeling

Observing GMP standards is crucial when it comes to pharmaceuticals. During production, the preferred radiolabeled compound is in most cases manufactured and tested only once in small lots. This tells you that before being used, the compound needs to be suitably manufactured. All impurities need to be identified and the C14 atom has to be correctly positioned before the drug development process starts. Now that C14 radiolabeling yields effective and stable compounds, it is the best option when GMP standards have to be obeyed.

The ease of carbon atom movement is what makes 14C labeling a better option than other compounds. This explains why carbon 14 is the element of choice when it comes to drug development and radiolabeling as a whole. With that said, let us now take a look at practical examples where radiolabeling comes in handy.

1. Oceanography

Truth be told, tracking particle movement in bodies of water can seem an impossible task. With the help of radiolabeling, however, this becomes an easy task for oceanographers. In most cases, radium isotopes are all that oceanographers need to monitor water movement in rivers, bays, and groundwater sources.

2. Medicine

Making an accurate medical diagnosis could mean the difference between life and death. Fortunately, this is what radiolabeling does best and thus help physicians avoid any misdiagnosis. This is achieved by giving patients radiolabeled drugs, either intravenously or orally. CT (Computed Tomography) scanning, MRI (Magnetic Resonance Imaging) and other imaging techniques help capture particular body part images after the isotopes enter the body. This goes a long way in saving lives by showing the inmost working mechanisms of cells and organs.

3. Drug Development and Research

Scientists heavily rely on radiolabeling when studying the metabolic activities of test drugs. This is such a big advantage because the researcher gets to know all that is going on as the test drug gets metabolized and eradicated from the body. This means that chemists understand what is happening during every step of the process. In the end, the pharmaceutical market benefits from new and effective drugs much more quickly. Were it not for radiolabeling, drug development and research would take ages and this can potentially result in a lot of fatalities.

Bottom Line

As you can see, radiolabeling is a key driver when it comes to developing and testing new materials. If your desire Is to learn more about it, contacting a radiolabeling company is all you need to do.

The Importance of GMP Quality Control

The Importance of GMP Quality Control

With today’s electronic sensing devices, the humidity of pharmaceutical cleanrooms can now be maintained and monitored with tolerances as small as one percent. Technology that helps monitor and control environmental factors is crucial for pharmaceutical, food, and cosmetic development, and related to these control factors is GMP quality control.

What Are GMP Standards?

Good manufacturing practices — GMP — are regulations set forth by the Food and Drug Administration to ensure that industries produce goods that are safe for civilian use. These regulations cover development, manufacturing, and storage, stipulating how processes should be completed, controlled, and monitored. Following GMP quality assurance protocols help industries maintain high standards and deliver products that have been tested thoroughly to ensure quality.

GMP quality control is crucial for establishing strong operating procedures that maintain the integrity of products. This is because of the stipulations regarding environmental conditions that correspond with testing and storage facilities. By ensuring that the highest standards are met during the testing, development, and storage stages, manufacturers can expect to mitigate testing failures, unnecessary contamination, errors related to environmental factors, and harmful deviations.

Why is GMP Quality Control Important?

GMP quality control measures are put in place and mandated by the government to ensure that pharmaceuticals, medical devices, food, and cosmetics, are safe for mass distribution. This helps ensure that none of the produced products contain harmful substances or contaminations that could otherwise cause problems to consumers. GMP quality control can also help mitigate the need for recalls or lawsuits that can arise should a faulty or defective product make it out into the market. For instance, GMP regulations were first enacted by the government in 1963, after thalidomide was nearly sold in the United States. Thalidomide had previously been linked to over 10,000 cases of birth defects in Europe and, without the resulting regulations, could have gone on to cause similar problems in the U.S.

Today the government enacted GMPs are more flexible and allow for manufacturer discretion within reason. This allows industries to collaborate and enact their own effective means for quality control and GMP storage conditions. Furthermore, this also allows manufacturers to take advantage of more technological advancements, as mentioned above, to ensure a greater level of control can be obtained throughout the development, manufacturing, and storage stages.

The Purpose of GMP Quality Controls

A consumer cannot, on their own, determine whether a drug, cosmetic, or food is effective or safe for application or consumption. One way manufacturers can help prevent defective products from making their way out into the market is by conducting testing at various stages of production. While this step can help, it also isn’t enough on its own. GMP protocols and training are essential for ensuring products are handled properly throughout the manufacturing process without risking contamination. All facilities should be well maintained and in good condition with hygiene and cleanroom guidelines strictly adhered to by all staff. Everyone should be trained in GMPs and know not to cut corners during any step of the process. Likewise, all equipment should be maintained, calibrated, cleaned, and verified as recommended and as needed. These facets are covered most by GMP regulations and adapting procedures to follow can improve product quality and ensure that risks of contamination and recall are mitigated.

How Do GMPs Differ from Other Quality Assurance Types?

While other methods of quality assurance exist, GMP is the only that is mandatory for manufacturers to follow. For instance, ISO quality certifications are encouraged but not required for manufacturers of food, drugs, or cosmetics. GMP is also the only one to include guidelines related to the verification of each process, preventative actions, the qualifications of vendors, and good laboratory practices, making it both thorough and comprehensive.

GMP quality control is essential for many industries, especially those that make topical or consumable products. Always be sure to know the guideless that affect your industry to avoid the risk of recall, lawsuits, or sanctions. Furthermore, if you utilize an outside storage facility, ensure that they too know GMP guidelines and how to follow them.

Understanding Pharmaceutical Ingredients and Compliant Manufacturing Practices

The United States produces more chemical products than any other country in the world. Pharmaceutical manufacturing involves the synthesis of active pharmaceutical ingredients (API) according to good manufacturing practice (GMP). Companies that offer API GMP solutions, tritium (3H) labeling, and carbon 14 (c14) radiolabeling (labeling with a radioactive atom or substance) can manufacture carbon isotope 14 (14C) and tritium radiolabeled APIs. This allows studies to be conducted for the Food and Drug Administration (FDA) phases 0, I and II microdosing and mass balance. These companies perform API GMP tests for synthesis, purification, and other testing to comply with FDA guidelines. Companies that provide this testing may also offer GMP storage for customers’ pharmaceutical compounds.

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