Blocking UV Light from Biopharmaceuticals
[[ToC]] Shedding UV light on single-use bags The biopharmaceutical manufacturing sector is undergoing rapid transformation, with single-use technology becoming a fundamental aspect of efficient and safe production. Among the various components utilized in this process, single-use bioprocess containers are crucial. New on the market are those that are designed to block ultraviolet (UV) light, which promise to safeguard sensitive biopharmaceutical products from the harmful effects of ultraviolet radiation during both storage and processing. Exposure to UV light can lead to degradation of some biologics. This degradation can result in reduced efficacy and potential safety concerns. By utilizing cold chain packagings that effectively block UV light, manufacturers can maintain the integrity and quality of their products throughout the entire bioprocessing chain. This article will help you understand when to consider UV-protective single-use bags, their benefits and how they contribute to the overall success of production processes. What are UV-sensitive biopharmaceutical products? The sensitivity of biopharmaceuticals to UV light can vary based on their chemical structure, formulation, and packaging. Here are some common products known for their UV light sensitivity: Monoclonal Antibodies (mAbs): These therapeutic agents are particularly vulnerable to UV light, which can cause structural changes and aggregation. Such alterations can compromise the integrity of mAbs, leading to decreased efficacy and safety concerns. [[1]] Recombinant Proteins: Like mAbs, recombinant proteins are also prone to denaturation and loss of biological activity when exposed to UV light. Their specific amino acid composition and structural characteristics make them susceptible to photodegradation. [[2]] Viral Clearance Products: In processes that involve viral inactivation, UV light is sometimes used to eliminate unwanted agents. However, the UV sensitivity of the target viruses must be carefully managed, as overexposure can damage both the viral particles and the biopharmaceutical product itself. [[3]] UV light exposure during biopharmaceutical manufacturing Biopharmaceuticals can encounter UV light at various stages throughout their lifecycle, including manufacturing, storage, transportation, and administration. Here are some scenarios where exposure may occur: Manufacturing and Processing: Certain steps in the production of biopharmaceuticals may involve UV light exposure. For instance, UV light can be used for sterilizing equipment and surfaces in cleanrooms or for inactivating viruses and bacteria during the manufacturing process. Packaging and Storage: If biopharmaceutical products are not adequately protected, they may be exposed to UV light during packaging and storage. Products that are improperly stored or packaged in transparent containers are particularly at risk, especially if they are kept in areas with direct sunlight or artificial UV sources. Transportation: During transport from manufacturing facilities to distribution centers or pharmacies, biopharmaceuticals may be exposed to UV light if they are not properly packaged. This exposure can happen during transit in trucks, planes, or other vehicles, particularly if the packaging lacks sufficient UV protection. Handling and Administration: Healthcare providers or patients may inadvertently expose biopharmaceutical products to UV light during handling and administration. For example, if a vial or syringe is left in direct sunlight or under UV lamps during preparation, it may suffer from UV exposure. How can pharmaceuticals be protected from UV light? There are novel single-use bag films that effectively protect the media or drug product inside from UV light. [[4]] A multilayered polyethylene film is used to enable blockage of both UVA and UVB wavelengths, ensuring that sensitive biopharmaceuticals remain safe from potential UV damage. Available in different sizes from small 100 ml sample bags to larger 2D bags for commercial production, can be applied in different single-use biomanufacturing processes. Single Use Support’s RoSS® shell can safely protect such UV-single-use bags during cold chain applications in all sizes. A protective secondary packaging as such helps to Reduce bag breakages Standardize fluid and cold chain management of single-use bags Maintain product quality during freezing/thawing processes including cold chain storage and cold chain shipping Single Use Support’s tamper-evident secondary packaging solutions hinders UV light from reaching the single-use bag. RoSS.KSET is an example of a stainless steel packaging solution that blocks UV light itself due to its UV permeability. It is designed to protect small single-use bags below 250mL to reduce product loss and maintain quality during cold chain applications. By combining UV-blocking bag films with protective secondary packaging, biopharmaceutical manufacturers can ensure comprehensive protection for their sensitive products throughout the manufacturing process, storage, and transportation. This layered approach is essential for maintaining product integrity, minimizing degradation, and ensuring the safety and efficacy of biopharmaceuticals. ROSS.KSET | Protecting small single-use bags RoSS.KSET offers the protection for drug substances with volumes less than 250 mL. The shell of our CGT bag protection system is robust, closed, safe and sterile – most suitable for cell and gene therapies or clinical studies. For larger volumes, RoSS can protect one or multiple single-use bags in one shell. More information RoSS® Shell | Protecting single-use bags The safest transport solution for all available single-use bioprocess containers. Robust. Scalable. Single-use bag independent. More information IRIS Manifold | Single-Use Assemblies As an expert in single-use solutions, we have made it our goal to deliver vendor agnostic single-use assemblies manufactured at highest quality standards in ISO 7 cleanrooms and sterilized within shortest lead times. Prevent downtime, ensure an uninterrupted supply chain and meet GMP relevant quality standards with our single-use manifold assemblies using silicone tubing and connectors of your choice. More information IRIS Single-Use Bioprocess Container Innovative. Robust. Individual. Single-Use. Make sure your supply chain is uninterrupted. Get your IRIS 2D single-use bioprocess container from Single Use Support in any size with the fastest possible delivery times. Store and ship anything from cell culture samples to large drug substance volumes reliably and on time. More information References Du Cheng et al. (2018). "Protection of therapeutic antibodies from visible light induced degradation: Use safe light in manufacturing and storage." European Journal of Pharmaceutics and Biopharmaceutics Kim Jennifer J. et al. (2023). "Trends in Light and Temperature Sensitivity Recommendations among Licensed Biotechnology Drug Products." The AAPS Journal. Meunier Sarah M. et al. (2017). "Evaluating ultraviolet sensitivity of adventitious agents in biopharmaceutical manufacturing." Journal of Industrial Microbiology & Biotechnology MDI (2024). "MDI launches Novel UV Light Blocking Single-Use Bag FIlm". Available at: www.ccubedbiotech.com/news/2024/1/26/mdi-launches-novel-uv-light-blocking-single-use-bag
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