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Overcoming Obstacles in the Development of Live Biotherapeutic Products

Live Biotherapeutic Products (LBPs) are a promising area of research and development for treating a wide range of diseases. However, the development of LBPs can be challenging due to various obstacles. Here are some of the significant obstacles in the development of LBPs and ways to overcome them:  

• Safety concerns: LBPs are live organisms, and there are concerns about their safety. Using LBPs requires stringent safety measures to ensure that they do not cause harm to the patients. One way to overcome this obstacle is to use well-characterized, non-pathogenic strains of bacteria with a long history of safe use in humans. 
• Standardization: LBPs are complex and dynamic biological systems that can be influenced by factors such as the manufacturing process, storage conditions, and patient-specific factors. The manufacturing process must be standardized to include quality control measures and testing methods to ensure consistent quality and efficacy. 
• Development data interpretation: Typical studies on drug product stability focus on small molecule drug substances, assessing degradation pathways and utilizing analytical techniques with high accuracy and precision. However, for LBPs, degradation effects cannot be directly extrapolated by elevating temperature, as this can drastically affect biological processes and would not be representative of drug product stability. Instead, studies need to be designed around potential exposure conditions and the effects of these monitored over an extended period. Compounding this complication, there is more inherent variability in typical LBP analysis (CFU by plate counting being one example) than usual for small molecule drug products. Hence, the correlation of several techniques is desirable, along with sufficient data collection points and careful use of controls. 
• Regulatory challenges: LBPs are regulated as biological products by regulatory agencies such as the FDA, and the regulatory requirements can be stringent. The development of LBPs requires compliance with regulatory guidelines, including preclinical and clinical studies, to demonstrate safety and efficacy. 
• Manufacturing challenges: The manufacturing of LBPs can be challenging due to these products’ complex and dynamic nature. There is a need for a robust manufacturing process that can ensure consistency in the quality of the final product. These often involve specialized handling conditions and minimizing environmental exposure. 
• Clinical trial design: Clinical trial design for LBPs can be challenging due to the need to consider various factors, such as the patient population, dosing regimen, and endpoint selection. There is a need for well-designed clinical trials that can provide robust evidence for the safety and efficacy of LBPs. 

Collaboration among various stakeholders, such as researchers, clinicians, regulators, and manufacturers, is crucial to overcome these obstacles. Investment in research and development is essential to understand the mechanism of action of LBPs and can also help overcome these obstacles. Additionally, innovative technologies such as genomics, proteomics, and bioinformatics can aid in developing and standardizing LBPs.

Contact our experts now to learn more about overcoming obstacles in the development of Live Biotherapeutic products.