Biologics are a booming business, with studies predicting a market size of $1.37 trillion by 2033. However, with this growth comes a renewed pressure to ensure safety and efficacy. Unlike traditional non-biological products, biological products like vaccines and probiotics are more vulnerable to degradation because they are made from living organisms or their by-products. This makes them more sensitive to environmental factors like temperature, humidity, light, and microbial contamination. Exposure to these elements can cause changes in chemical composition, potency, and safety. As a result, understanding the shelf-life of these products is vital not only for meeting regulatory standards but also for ensuring public health.
Biological shelf-life testing is a comprehensive process verifying that these products remain effective, safe, and potent throughout their intended lifespan. If you’re manufacturing biologics that promote the health and wellness of consumers, here is why you should consider biological shelf-life testing.
How Biological Shelf-Life is Measured
Biological shelf-life testing measures a product’s stability over time. This typically includes tests to evaluate:
- Chemical Composition: Are the active ingredients potent and effective?
- Physical Appearance: Are there any changes in color, texture, or formulation over time?
- Biological Activity: Has the efficacy remained intact?
Manufacturers use a combination of accelerated aging and real-time stability testing to assess a product’s longevity. Each method plays a crucial role in predicting and validating shelf-life under various conditions.
Why is Biological Shelf-Life Testing Critical?
From brand reputation to consumer safety to financial stability, biological shelf-life testing should be a vital component of any go-to-market strategy. Biologic shelf-life testing can:
- Predict product longevity
- Minimize risks and ensures products remain effective
- Help manufacturers stay in line with industry standards avoid costly recalls.
It’s also worth noting that regulatory authorities such as the Food and Drug Administration (FDA) require manufacturers to conduct shelf-life testing for biological products to ensure their safety and efficacy. Failure to comply with these regulations can result in the product being recalled from the market, damaging a manufacturer’s reputation and potentially leading to legal consequences.
Accelerated Aging Testing
One common method used in biological shelf-life testing is accelerated aging, where products are subjected to extreme conditions such as high temperatures and humidity to simulate long-term storage. This process allows manufacturers to predict how a product will degrade over time and adjust their storage recommendations accordingly. For instance, when testing vaccines, accelerated aging can reveal how freezing or refrigeration impacts potency, which is critical for maintaining efficacy across varied storage conditions.
Real-Time Stability Testing
While accelerated aging provides quick insights, real-time stability testing determines the true shelf-life of a biological product. This method involves storing products under standard conditions (e.g., recommended temperature and humidity) and monitoring their stability over time. Real-time data offers a more accurate representation of how products will perform in actual storage environments and is crucial for compliance with the FDA.
Accelerated aging and real-time testing can work hand-in-hand for the most accurate results. By comparing accelerated aging results to real-time data, manufacturers can ensure that their shelf-life estimates are trustworthy.
Ensuring the Longevity and Safety of Your Biologics
As the biologics industry continues to grow, ensuring the safety, efficacy, and stability of these sensitive products becomes paramount. With biological shelf-life testing, manufacturers can accurately predict the longevity of their products, mitigate risks, and safeguard public health.
At Purple Diamond, we provide comprehensive solutions that ensure your products maintain their potency and safety over time. Our team works closely with clients to design customized testing protocols that align with regulatory requirements and industry best practices. Whether you’re launching a new biologic or ensuring continued compliance with FDA guidelines, our testing services will help you meet both consumer needs and regulatory expectations. Contact us today for a free quote.
