When it comes to treating a wide variety of diseases, large molecule therapeutics (biologics) has proven quite effective. From autoimmune disorders and chronic illness to oncology-related applications, they have aided in improving the quality of life for many patients. Unfortunately, despite many successes, there are certain limitations to biopharmaceuticals that can hinder wide-scale commercial adoption.
Unlike conventional small molecule drugs, biologics tend to be comparatively delicate. Proteins have specific traits that make them unsuitable for long-term storage. For example, they can aggregate over time, which decreases both their efficacy and shelf-life.1 Since a drug’s success hinges on alleviating patients’ symptoms, such negative traits must be avoided if at all possible. Just as scientists do not make use of chemicals past their expiration date, healthcare providers will ignore therapeutics that fail to deliver expected results.
Beyond IV Infusions of Therapeutic Biologics
Traditionally, therapeutic biologics are given to patients via intravenous infusion. This technique allows a large volume of solution to be delivered slowly. It’s a functional treatment mode, but it isn’t the most convenient since biotherapeutic infusions are usually administered in a hospital setting. The combination of patient inconvenience and high associated costs has led to a push toward moving biologic treatment away from hospitals.
While a highly desirable goal, a few challenges currently prevent a complete shift away from hospitals. It’s unreasonable to give a patient the same volume of therapeutic biologics to bring home with them. They may not be able to transport the solution safely nor may they have the equipment necessary to administer treatment under controlled conditions. The obvious solution would be a high-concentration, low-volume solution, but therein lies the difficulty. The higher-concentration a biologic solution, the more likely it is to aggregate and fall out of solution. Ineffective solutions suitable only for short-term storage are hardly convenient or cheaper alternatives to IV infusion since they will ultimately require more frequent replacement on the part of the patient.
One method that companies have adopted to circumvent these limitations is lyophilization. Freeze-drying allows for the preservation of perishable materials and makes them easier to transport, both of which are crucial for drug testing or moving therapeutic biologics out of hospitals and into patient homes.2 It’s important to remember that the ability to store biopharmaceuticals for extended periods of time isn’t the only desired end goal. Therapeutics also need to remain stable under a reasonable range of conditions. Hospitals and research facilities may have the capacity to store products in a stringently controlled environment, but the same cannot necessarily be said about patient homes. Among the benefits offered by lyophilization is providing stability to therapeutic proteins sensitive to external stressors such as temperature and pH changes.
The Future of Long-term and Stable Shelf Life for Therapeutic Biologics
Freeze-drying isn’t the only method of turning biologics into a convenient, stable form. One company recently patented the use of stabilizers in the creation of biopharmaceutical powder. The firm claims that this new technique has a few advantages over freeze-drying including speed, lower cost and dosage flexibility.3 The latter two are especially desirable in the quest for shelf-stable therapeutic biologics since lower cost is one of the driving reasons for moving away from IV infusions and dosage flexibility is one of the reasons why IV infusions remain a mainstay.
If true, this innovative new technology could revolutionize the field of long-term, shelf-stable biologics. Imagine being able to store therapeutic proteins as bulk dry powders or active pharmaceutical ingredients for longer than seven years. With this, it could be possible to dissolve the powdered formulation into a high-concentration solution that can be delivered by a single injection, providing the efficacy and convenience patients highly prize.
As companies continue to develop better ways to store therapeutic biologics for the long-term, the need to ensure that these new forms are safe throughout their newly extended lifetimes will also increase. The BIOVIA Quality Testing Solution helps biologics firms release safe and compliant products by providing tools that support procedural enforcement, electronic documentation and advanced reporting. Manufacturing teams can then make better, more efficient decisions regarding the viability and safety of newly developed shelf-stable large-molecule therapeutics. If your biopharmaceutical firm is interested in a digital solution that aids your efforts to create safe but more convenient forms of current products, then contact us today to learn more.
- “Predicting Long-Term Storage Stability of Therapeutic Proteins,” November 2, 2013, http://www.pharmtech.com/predicting-long-term-storage-stability-therapeutic-proteins ↩
- “Biologics and R&D investment driving freeze-drying demand says Symbiosis,” May 21, 2015, http://www.biopharma-reporter.com/Downstream-Processing/Biologics-and-R-D-investment-driving-freeze-drying-demand-says-Symbiosis ↩
- “UK R&D firm patents biologics powder storage technique,” February 27, 2015, http://www.biopharma-reporter.com/Upstream-Processing/UK-R-D-firm-patents-biologics-powder-storage-technique ↩