Viral contamination is a threat to biopharmaceutical product development.1 Contaminants can be present in the cells and source materials or introduced during manufacturing, necessitating viral clearance studies for all biological drugs, including vaccines, blood products and cell and gene therapeutics.2
Viral clearance and viral safety are key components of risk mitigation.3 Candace Fox, PhD, virologist and department scientist at Nelson Labs Bozeman, notes that while these are a small component of the biopharma development lifecycle, time-wise, they represent a crucial element of taking a biopharmaceutical to market.
Partnering with experts ensures the process is efficient, effective and meets all regulatory guidelines. In fact, ICH Q5A(R2) guidelines require viral clearance studies to be carried out in separate laboratories to avoid the unintended introduction of viruses into production facilities.4
“Every study is essentially a custom study, and the more complex it gets, the more insight biopharma companies need,” John Dyba, Director of Business Development at Nelson Labs Bozeman says. “Guidance through that complexity is becoming crucial to mitigating obstacles on the road to market.”
Safety first
Increased demand for biopharmaceuticals has fueled the demand for viral clearance studies and resulted in a market size expected to grow from $718.4 million in 2024 to more than $2 billion in 2032, representing a 17.7 percent CAGR.5
Nelson Labs offers services ranging from viral safety studies that test disinfectants against known viruses to viral clearance studies that test the effectiveness of the manufacturing process for clearing viruses. The COVID-19 pandemic led to a significant spike in demand for these services, and Nelson Labs has helped many manufacturers address the need for urgent viral clearance studies to safeguard patients globally during the pandemic.
New guidance from the U.S. Food and Drug Administration for ICH Q5A R2 to describe mitigation strategies to assure the viral safety of biotechnology products based on advances in scientific knowledge and regulatory expectations has also contributed to increased demand for viral safety and viral clearance studies. 6
Detecting endogenous and adventitious viruses requires extensive testing.1/span> The process requires considering the source material, potential contamination due to the manufacturing production and assessing the ICH Q5A(R2) requirements to design a panel that encompasses all of the relevant viruses, Fox explains.
“The tissue sources used in biopharmaceutical products can have contaminating viruses, and it’s so important to make sure that the manufacturing processes clear out all these viruses so there’s not a threat to public health,” explains Fox. “In the lab, we take that specific tissue, spike in a range of viruses and perform a scaled-down version of their manufacturing process to ensure that it can prevent viral contamination in the end product.”
Virus testing is part of the process for biopharmaceutical products to enter phase I clinical trials and achieve market authorization. To minimize the risk of viral contamination and ensure that pharma companies can meet their regulatory goals, Nelson Labs has biosafety level 2 and 3 labs with an ICH Q5A(R2)-compliant viral clearance validation service and can test over 100 viruses.
Expert insights
Research shows that the financial impacts of a bioburden incident can be substantial, with a commercial impact of up to $1 billion in lost revenue.7
Given the complex nature of viral clearance studies and the potential repercussions of failure, including additional downstream costs linked to failed production, scrapped batches and QA investigations, partnering with experts to properly design the studies is essential.
“Designing and implementing viral clearance studies are crucial for the pharmaceutical manufacturing perspective,” Fox says. “And these are so complex because they require the proper manipulation of the manufacturing process to ensure that viral contamination is prevented.”
Some biopharma companies come to Nelson Labs with a predetermined panel of viruses that could be potential contaminants of their target tissue, while others need guidance on virus selection and experimental design.
Virologists work together to address specific customer concerns and make recommendations for panels encompassing a wide range of viral structures and characteristics. The process includes selecting the right tests to detect viruses, accounting for the potential contamination of biopharma products during manufacturing, and determining how to ensure that products are free of contaminants and safe for use.
While an in-house lab may be able to begin the analysis, virologist expertise is essential to ensure safety and compliance, not to mention third-party requirements by the ICH. Manufacturers don’t just benefit from the results of custom viral clearance studies; biopharma companies that partner with Nelson Labs benefit from access to a large expert network.
“Our experts are truly industry-leading,” says Dyba. “Nelson Labs has a dedicated virology lab built into a larger pharmaceutical network. This gives us extensive experience in general pharmaceutical development. Combined with our virology expertise, we have the capacity and scientists to address any challenge our customers might face.”
CTA: Learn more about partnering with Nelson Labs for viral clearance studies and viral safety at www.nelsonlabs.com
References:
1. Detection and Clearance of Viruses in the Biopharmaceutical Industry.” BioProcess International. https://www.bioprocessintl.com/viral-clearance/detection-and-clearance-of-viruses-in-the-biopharmaceutical-industry. December 17, 2019
2. “Viral Clearance Studies: Challenges and Beyond.” BioPharm International. https://www.biopharminternational.com/view/viral-clearance-studies-challenges-and-beyond. December 1, 2022.
3. “Mousavi, S. M. R., Hosseini, S.M., Ansari, S. “Evaluating the viral clearance ability of continuous monoclonal antibody purification steps, in order to inactivate and/or remove four model viruses.” Iranian Journal of Microbiology. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10628082/. October 2023.
4. “ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin.” European Medicines Agency. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-5-r2-viral-safety-evaluation-biotechnology-products-derived-cell-lines-human-or-animal-origin-step-2b_en.pdf. October 10, 2022.
5. “Viral Clearance Market Size, Share and Industry Analysis, by Method.” Fortune Business Insights https://www.fortunebusinessinsights.com/viral-clearance-market-105611. May 27, 2024.
6.“Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.” U.S. Food and Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q5ar2-viral-safety-evaluation-biotechnology-products-derived-cell-lines-human-or-animal-origin. January 10, 2024.
7.“Williams, K.L. “The Biologics Revolution and Endotoxin Test Concerns.” Springer Nature. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7123716/. March 18, 2019.
