It is understood within the healthcare manufacturing industry that biological products present additional contamination risk compared to synthetically manufactured pharmaceuticals and medical devices. Prior instances of contamination have resulted from agents that remained undetected until market introduction. Ensuring a comprehensive program for viral contaminant mitigation is crucially important to patient safety and regulatory compliance. Nelson Labs Bozeman offers a complete suite of viral clearance services to ensure a biological product’s safety at all stages of development, manufacturing, and release.
- Biopharmaceutical Process Validation
- Blood Product Viral Clearance
- cGMP Compliant Viral Screening
- BSL-3 Clearance Evaluations
- Medical Tissue Device Studies
Biopharmaceutical Process Validation
Ensuring the successful removal of viral agents is a crucial aspect of the safe, effective, and efficient development and deployment of biopharmaceutical products. Our ICH Q2-compliant viral clearance validation service offers top-notch expertise to help you achieve your safety and regulatory goals, minimizing the risk of viral contamination in your products.
In collaboration with our highly experienced Virology team, we develop custom-tailored study designs that address viral contamination validation across all critical stages of your biopharmaceutical manufacturing process. From the initial establishment of cell lines to the final product purification steps, our services ensure the utmost accuracy in the prevention and elimination of viral contaminants.
By employing a diverse range of advanced techniques, we analyze and verify the efficiency of your viral agent removal procedures, helping you maintain uncompromising quality standards for your biopharmaceutical offerings. Our client-focused approach ensures that each project benefits from the close and continuous involvement of our expert team, providing guidance and support tailored to your unique requirements and challenges.
Blood Product Viral Clearance
Biologic products derived from blood, such as vaccines, plasma, and other therapeutic agents, require special handling and processing to ensure their safety for clinical use. With the increasing number of blood-based biologics in development, the importance of viral clearance services cannot be overstated.
Our facility offers specialized viral clearance services that aim to mitigate the risk of viral agent transmission from blood-based biologics. Our experts are equipped to evaluate and validate your viral clearance process against specific viruses of interest, including HIV, hepatitis B and C, and West Nile Virus. This is done through a rigorous study design process that draws on decades of experience in developing appropriate protocols for viral clearance needs.
Our team of experts works to design a study that suits the unique viral clearance needs of your specific blood-based biologic product. Through our specialized viral clearance protocol, we aim to ensure that divergent viral agents are effectively removed from your product. This gives you greater confidence in the safety and quality of your biologic product, and thus contributes to compliance with regulatory standards. By offering specialized viral clearance services for blood-derived biologic products, we hope to support the development of safe and effective biologics for clinical use. We are committed to working with you to ensure that your product meets safety standards and is suitable for use in patients.
Viral Safety – cGMP Screening
cGMP (current Good Manufacturing Practice) stands for a set of guidelines and regulations that ensure the quality and safety of pharmaceutical products during their development, manufacturing, and distribution. At our virology laboratory, we offer a cGMP-compliant viral clearance and screening service.
This service provides lot release, quality, and regulatory compliance support, allowing you to have confidence that your products will be compliant for market entry. Furthermore, our services are designed to be easily integrated into any existing manufacturing process, and we can support both batch and continuous processing methods for viral clearance in upstream and downstream capacities.
Our screening service focuses on the detection and quantification of viral particles in product samples using sensitive analytical techniques. This is important to monitor the clearance and ensure the absence of any residual viral contamination that could compromise product safety.
The lot release and quality control components evaluate samples from each batch or lot of the product before it is released onto the market, to confirm compliance with specification and potency criteria and to identify any potential quality issues.
BSL-3 Clearance Evaluations
At our facility in Bozeman, Montana, we specialize in providing Contract Research Organization (CRO) services in the field of viral clearance solutions. We take pride in being one of the select CROs that operate within the confines of a Biosafety Level-3 laboratory, which ensures the utmost safety and security of our staff and clients.
Our team of highly skilled virology professionals provides precise and safe validation of your viral elimination strategies throughout every phase of development. We understand the importance of verifying the efficacy of viral clearance methodologies against even the most intricate viral contaminants. Our team is equipped with the latest tools and technology to ensure that the most up-to-date and effective methods are utilized, from the initial cell line to the final product.
Medical Tissue Device Studies
At our company, we hold a commitment to providing a thorough viral clearance service that is uniquely tailored to the needs of tissue and tissue-derived medical devices. Our team of experts works closely with every client to develop a personalized validation strategy, designed around individual tissue specifications and applications.
By leveraging our expertise and various proven methodologies, we can help you establish a robust and effective viral inactivation and removal process, ensuring that your product is safeguarded against the most relevant viral agents associated with your particular tissue type and application. This not only guarantees the safety and reliability of the medical devices you produce, but also enables you to adhere to stringent regulatory requirements and maintain the highest industry standards.
In partnering with our dedicated team of experts, you can expect thorough guidance and support through each step of the validation process, from initial consultation to final implementation, ultimately fortifying the efficacy of your viral clearance strategy.