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Understanding DNA and RNA Radiolabeling

There is a lot of information that goes into understanding DNA and RNA radiolabeling. Radioisotope labeling is a traditional method for nucleic acid labeling, and it is highly essential to the detection, visualization, and purification of DNA and RNA.

Different Types of Impurities in Pharmaceuticals

An impurity in pharmaceuticals is classified as any component that is not the entity defined as the drug substance. In addition, for a drug product, any component that is not a formulation ingredient is considered an impurity. There are three different types of impurities in pharmaceuticals that API manufacturing companies must be wary of. Below, we provide a...

How Drugs Are Metabolized in the Body

Metabolism is the biotransformation that some drugs undergo when the body chemically alters them. Metabolism is an important process that produces the intended therapeutic effects of a certain drug and eliminates the drug from the body through urine or bile. Drug metabolism can be tricky to understand—here’s everything you need to know about how drugs...

The Importance of GMP in Pharmaceutical Manufacturing

Good manufacturing practice or GMP is a system that ensures products are consistently produced and controlled according to quality standards. The importance of GMP in pharmaceutical manufacturing is to minimize the risks involved in any pharmaceutical process, such as custom radiolabeling, that can put consumers at risk if the proper quality control isn’t in place.

Understanding Active Pharmaceutical Ingredients

Have you ever wondered how pharmaceutical drugs work? The ingredients in a pharmaceutical drug are responsible for the physiological reaction your body has to the medication. Many components are involved in the development of pharmaceuticals, but active pharmaceutical ingredients are the ingredients that produce the intended effects of the drug an individual is taking.

How To Choose the Right CMO for Your Pharmaceutical Product

The development of a new drug is a complex task and requires many evaluations and decisions before a commercial launch. Some biotech and small pharmaceutical companies are choosing to outsource most or all their drug manufacturing efforts throughout the development phase with a contract manufacturing organization. Choosing the right contract manufacturer is imperative in pharmaceutical...

How Radiosynthesis Supports Drug Development

The demand for radioisotopes in medicine is growing at a rapid rate, as radioactive compounds can be used as tracers to understand mass balance and metabolic profiles of drugs. Carbon-14 is a common radioactive isotope that’s used as a tracer in biochemistry methods such as DMPK and ADME studies.

The Purpose of Preliminary Testing for New Drugs

The purpose of preliminary testing for new drugs is primarily to determine the safety and efficacy of potential substances, among many other drug characteristics along the way. Preliminary drug testing tests the safety and efficacy in three different phases. Each phase tests for various elements of safety and efficacy across increasing populations in order to...

Pharmaceutical Manufacturing Safety Considerations

Every workplace presents a unique set of dangers. The pharmaceutical manufacturing industry presents many risks, from manufacturing-specific considerations to pharmaceutical safety hazards. While health and safety can often be difficult to maintain, the pharmaceutical industry must follow safety standards and regulations. From basic protections to highly specified pharmaceutical precautions, pharmaceutical manufacturing safety considerations cannot be...

The Importance of ISO Class 7 Cleanrooms

A cleanroom is a controlled environment that has a low level of pollutants such as dust or chemical vapors. Cleanrooms are typically used in manufacturing or scientific research labs, such as a radiochemistry laboratory, where an ISO Class 7 cleanroom is required. The cleanroom classification standard ISO 14644-1 requires specific particle counts, such as ISO 7, to...

Applications of GMP in Clinical Trials

When patients are administered medications, they trust that the doctor prescribing the drug has confidence in it. A doctor’s faith in a specific drug comes from trusting that the manufacturers used Good Manufacturing Practices (GMP) during clinical trials to ensure the quality and safety of the drug. A GMP certified manufacturer will follow these applications of GMP in clinical trials.

Characteristics of Radiopharmaceuticals

Radiopharmaceuticals are a drug grouping of unique medicinal formations. These formations use radioactive isotopes, also known as radioisotopes, in clinical diagnosis, as well as for therapeutic interventions. Common uses of radiopharmaceuticals in clinical diagnoses are to determine the functioning of the liver, lungs, and kidneys, blood flow to the brain, bone growth, the predictive effects of surgery,...

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