The biopharmaceutical industry has the enormous responsibility of developing safe, effective and economic drug therapies to treat a multitude of diseases. The research and development of these therapies usually takes 10 to 20 years to get from idea to market, typically costs billions in monetary capital, and involves hundreds, if not thousands of team members in multiple countries.
Drug development defines the process of bringing a new drug to the market once a target compound has been identified through drug research and discovery. The drug development process includes many phases but can be broadly broken into two main stages: pre-clinical research phase where animal models, cell-line models, and microorganisms are used and then clinical trials where human models are used.
During the development phase, every company and every team has one priority: making a quality pharmaceutical product. What makes a quality product? Every drug must be safe, effective, non-toxic, pure, and potent.
As a drug is researched and developed, it must be tested multiple times, and at different phases of manufacture to ensure its quality. When a drug has passed the development phase and is in the production phase, quality controls are also put in place to ensure the quality of every lot (or production shipment) that is released. The main tool that’s used by the biopharmaceutical industry for this testing is the bioassay, or the biological assay.
A bioassay is ultimately a very specific and intricately designed test used as a quality check during the drug development and lot release process. Bioassays can provide data on several key issues involving drug quality: efficacy, potency, purification, toxicity, and therapeutic potential. There are several broad types of bioassays but in general they test a drug’s efficiency on either a living organism or on a living sample, such as a cell line. Also, bioassay test results are compared to desirable values or outcomes. This is different from other scientific experiments that typically compare test results from several different treatments to one another in order to find the most effective treatment.
The ability of bioassays to produce reliable and reproducible results is perhaps their greatest advantage. During drug development it’s absolutely vital that the effects of the drug at the usable dosage are the same every single time. A quality control check can only be relied upon if it is consistent. Additionally, testing the potency and purity of drug products prior to lot release is vital to ensure that only safe and effective products are released for public use.
Assays are usually performed to measure the effects of a substance on a living system and are vital in the development of new drugs and during the mass production of those drugs. Bioassays are also used to monitor levels of environmental pollutants in ecosystems as well as their effects on biological systems.
Bioassays can be used to determine the concentrations or dosage requirements for test drugs or the therapeutic potential of compounds on cells, tissues, or whole animals. These compounds can be synthetic or natural and can be hormones, plant extracts, bacterial toxins, vitamins, enzymes, etc. The bioassay is used to measure the effects of the test compound by comparing its measured effect to a standard preparation. One of the biggest advantages of many bioassays used in lot release is that their results are quantifiable. Therefore, a drug or raw materials lot can easily be marked as a pass or fail based on the quantitative data that is obtained from a purity or potency bioassay.
The discovery of new therapeutic drugs for many diseases has become an expensive and long endeavor. Each drug target must be screened against libraries of already discovered and tested therapeutic agents which can be over 1 million chemicals. Bioassays allow researchers to accomplish these data mining screens in a timely way and enable the gathering of vital information on specific diseases.
Once a test drug has been determined to be safe, pure, and effective during both primary and secondary bioassays testing phases, the drug can be approved for pre-clinical and clinical trials.
Therefore, the use of the bioassay is vital for ensuring product safety before the drug is tested on human subjects and ultimately released to the public market for mass consumption. When a drug is approved for manufacturing, quality control checks continue at all stages through the production process. These lot release quality checks and bioassays ensure that drugs on the pharmacy shelf are pure, potent and safe for the patients consuming them.
By Gina Buss