The U.S. has long been a driver of scientific discovery. From cures to vaccines, medical implementation of these advances has been at the forefront of our nation’s goals. The finding of radiolabeling applications is one such breakthrough.
Radiolabeling (and isotopic labeling) is valuable to the developments of other breakthroughs: C14 radiolabeling (also known as 14C labeling) allows scientists and researchers to track the passage of an isotope — an atom with a detectable variation in neutron count — through a reaction, metabolic pathway, or cell. For example, if you wanted to create a new drug to treat cancer, you’d want to be sure that it’s going to the region infected with cancer, preferably the cancer cells themselves. These radiolabeled compounds are visible so scientists can know for sure that their drugs are where they’re supposed to be.
However, when you’re dealing with radioactive materials, even when they’re as minuscule as radionuclides, certain rules and regulations need to be put in place. In 1975, the Food and Drug Administration (FDA) approved the use of radioactive drugs as safe, but only if they met certain requirements. The Radioactive Drug Research Committee (RDRC) Program began the same year to “[permit] basic research using radioactive drugs in humans without an Investigational New Drug Application(IND) when the drug is administered under the following conditions”: that the research is considered “basic science research” and is done for the purpose of advancing scientific knowledge; the research study is approved by an FDA-approved RDRC; the dose of the radioactive drug is known not to cause any clinically detectable pharmacologic effect in humans; the radiation dose is justified by the quality of the study being undertaken and the importance of the information it seeks to obtain.
In a similar, equally important vein, any scientific research or testing in a laboratory must be held to the GMP standards. Good Manufacturing Practices are vital to preventing contamination that could destroy the efforts made so far, as well as potentially harm others: in 2012, a fungal meningitis outbreak occurred in a pharmacy in the Northeast due to poor manufacturing procedures — 48 people died because of the shortcuts, lapse in cleanliness, and poor maintenance of the pharmacy.
If we are to continue to make leaps and bounds in the name of science, it’s absolutely essential that we follow GMP standards (as well as RDRC codes) to the letter.
Getting a new drug off the ground takes a lot of work. You have to follow stringent (and very specific) FDA guidelines, exercise top-tier clean room standards (and GMP standards) to prevent contamination and reduce risk, and perform dozens of radiolabeled tests to ensure the drug is going to the right target within the human body. With so many hoops to jump through and factors to keep track of, it’s a miracle we’ve produced the thousands of drugs already on the market! Read more
When it comes to pharmaceuticals, proper storage is absolutely essential. Guidelines and regulations for GMP storage conditions are in place because even if a product is manufactured properly, something can go wrong if the product is stored improperly. So let’s explore a few basic guidelines to keep in mind when storing pharmaceuticals.
With the U.S. holding more than 45% of the global pharmaceutical market, it’s important for laboratories to abide by certain regulations. The regulations in place help to maintain pharmaceutical quality so they’re safe for consumers. Good Manufacturing Practice (GMP) regulations give pharmaceutical labs standards they need to meet to ensure their products are both safe and effective. So let’s take a closer look at why GMP regulations are so important in today’s pharmaceutical labs.
Carbon is an element that has been used for a variety of scientific purposes over the years, like radiocarbon dating, which was developed around 1946 by Willard F. Libby. But in today’s pharmaceutical labs, carbon 14 plays a crucial role in drug development. And because of depleting supplies and increasing prices, carbon 14 production is at an all-time high. But what can carbon 14 be used for and how is it used safely? Let’s take a look at a few important things to know about C14 radiolabeling.
Radiolabeling is a process that is frequently used in medicine, drug research and development, and environmental case studies. Using this process, researchers can track the movement or breakdown of target molecules. For instance, drug researchers can see how a new drug is metabolized as it travels through the test subject’s body. To accomplish this, atoms within the target molecule are replaced by isotopes of the same atom.
While there are a lot of essential pieces of equipment used in laboratories, fume hoods are one of the most important devices labs have. When lab technicians are working with materials that are classified with health hazards, it’s important to work in an area that has a fume hood so the harmful fumes can be removed safely from the area. A recent survey found that about one-fifth of laboratories were planning on replacing their fume hood, with one-third of them needing to be replaced due to old age. So if you’re in the market for a new fume hood, let’s take a look at some of the most common types of fume hoods.
With the United States being the number one largest national producer of chemical products in the world, it’s no surprise that there is an astounding number of laboratories throughout the country. And whether that laboratory is engaged in Carbon 14 production or pharmaceutical research and development, many laboratory settings contain cleanrooms. In labs, cleanrooms serve a very important purpose, and this article is going to take a closer look at the benefits cleanrooms can offer.
When it comes to handling sensitive items in laboratories, like radiolabeled compounds, it’s important to make sure they’re stored, worked with, and manufacturers in proper temperatures. Under proper GMP storage conditions, like in a cleanroom, compounds and chemicals can be manufactured and used correctly. Cleanrooms are an important part of any laboratory — compared to the ambient outdoor air in urban areas, which contain 35 million particles per cubic meter, cleanroom environments offer just 12 particles per cubic meter. This allows lab technicians to control the environment chemicals are used in. So let’s take a look at a few reasons why temperature monitoring in labs is important.
Testing the purity of substances is one of the most important tasks chemical manufacturers are faced with. If an impure substance is used, it could cause adverse effects. For example, a 2012 fungal meningitis outbreak that caused the deaths of 48 people was traced back to a pharmacy that hadn’t been using proper cleaning and maintenance techniques. If the pharmacy had taken more time to use proper methods in the lab, including assessing the purity of the substances used in the drug that caused the outbreak and proper GMP storage conditions, the disaster could have been prevented. So, how do chemical manufacturers assess purity? Let’s take a look at a few common methods used in today’s labs.