Are kid gloves needed for biologics?

16 October 2023

Biologic drugs have revolutionised the field of medicine by offering innovative treatment options for various chronic and life-threatening diseases. Unlike traditional chemical-based drugs, biologics are made from living organisms. They have proven to be effective in treating conditions like cancer, autoimmune disorders, and central nervous system disorders. However, their unique nature makes them susceptible to various factors that can compromise their efficacy and make them tricky to handle. Here, we list some of the most common factors that damage biologicals, but through working on the delivery of biologics over many years, we have also found some other interesting, lesser-known challenges that you can face.

How biologics work

Biologics work by targeting specific molecules or cells in the body that are involved in the development and progression of a particular disease. They can be antibodies, proteins, or other biological molecules that interact with disease-related targets. By blocking or modulating these targets, biologics can effectively treat the underlying cause of the disease and provide relief to patients.

Factors that can damage biologic drugs

Hydrophobic interfaces: proteins in aqueous solutions can be sensitive to hydrophobic interfaces such as contact with plastics, silicone, air bubbles and suchlike.

Temperature variations: Biologic drugs are often sensitive to temperature fluctuations. Exposure to extreme heat or cold can denature or degrade the biologic molecules, rendering them ineffective. Proper storage and transportation at the recommended temperature range are crucial to maintaining the drug’s integrity.

Light: Some biologics are light-sensitive and can degrade when exposed to ultraviolet (UV) or visible light. Manufacturers typically package these drugs in opaque containers or use light-resistant formulations to prevent damage.

Contamination: Biologic drugs are produced in sterile environments to avoid contamination. Even tiny particles or microorganisms can compromise their quality and safety. Strict quality control measures are in place during manufacturing to minimize contamination risks.

Time: The stability of biologic drugs over time is a significant concern. Over a prolonged period, biologics can undergo degradation, leading to reduced potency.

Improper handling: Improper handling, such as vigorous shaking, can disrupt the delicate structure of biologic molecules. Healthcare professionals need to be trained in the correct administration techniques to minimize the risk of damage during preparation and administration.

Drug-Drug Interactions: Biologics may interact with other medications or substances, potentially affecting their efficacy or safety. It’s crucial for healthcare providers to be aware of potential interactions and manage them appropriately.

Immunogenicity: Biologic drugs can stimulate an immune response in some patients, leading to the production of antibodies against the drug itself. This can neutralize the drug and reduce its effectiveness over time.

What else can make a difference?

Biologic drugs have transformed the treatment landscape for many challenging medical conditions. However, their unique nature makes them susceptible to various factors that can damage their efficacy. Through our experience of developing devices to administer biologics, we have come across most of the challenges. If you need help with how best to develop a drug delivery device that best suits your biologic, please contact us today.