Cell-based therapies have been accepted worldwide for the treatment of diseases. However, the biologics derived from cells, specifically mammalian cells, are at greater risk of viral contamination. The virus belongs to a group of microorganisms that are composed of RNA and DNA encapsulated by a protein coating. The contamination of viruses can affect the cell culture process and downstream processing, making therapeutics unsuitable for the consumption of humans. Pharmaceutical companies must perform viral clearance testing of therapeutics at each stage of manufacturing to ensure the safety and efficacy of the drug. Viral clearance involves the inactivation and removal of adventitious viruses by following the regulatory guidelines provided by the US Food and Drug Administration, European Medicine Agency, and International Council for Harmonisation.
Unfortunately, the viral clearance testing process is not straightforward, even though the regulatory bodies have provided the guidelines. It is complex, time-consuming, and requires expertise and potential equipment that enhances the overall cost of the viral clearance testing procedure. To overcome these challenges, several pharmaceutical companies have shifted to the outsourcing of viral clearance testing. At present, many companies, including Creative Biolabs, Eurofins Scientific, and Microbac Laboratories, are actively engaged in providing efficient viral clearance testing services to help researchers focus on the development of drugs. As more therapeutic drugs enter the market, it is anticipated that the viral clearance market will witness steady growth at a CAGR of 10%.
Common Challenges of Virus Clearance Studies
Before a therapeutic drug gets approval from the FDA, it is vital to perform viral clearance studies to make sure that the final product is free from extraneous virus agents. Viral clearance testing is a complex process, and continuous changes in the viral clearance guidelines by the regulatory bodies create problems for pharmaceuticals. In addition to regulatory challenges, other challenges that affect the viral clearance testing process include;
- Viral Diversity
Viruses have diverse structure properties and easily mutate—which leads to variation in the genetic behavior and makeup. The variability of the virus structure can also complicate the process of virus clearance testing. As a result, pharmaceutical companies face problems in clearing viruses because the virus strain they want to clear may get mutations, and it doesn’t match with the reference strain.
- High Cost of Viral Clearance Testing
The cost of viral clearance studies technology is extremely high, and it may require experts for the viral clearance testing process as they can be well-versed with medical equipment and testing processes. On average, there is a viral clearance validation process of more than $30,000 and even more. The high cost associated with the process of viral clearance and the requirement of expertise could hinder the wide-scale adoption of the process.
- Complex Validation Process
The viral clearance testing validation process is important to ensure that the approach allows consistent removal and inactivation of the process and meets regulatory standards. The biomanufacturing process is complex and often involves multiple steps, such as purification, cell culturing, raw material collection, and validation for viral clearance. However, validating viral clearance at each step across different manufacturing units can be complex and require innovative solutions that further enhance the cost of research and development.
- Overloading and Interference of Other Components
Biopharmaceutical products contain different components, such as antibodies, proteins, and other components. These biologics can also interfere during viral clearance studies, making it challenging to isolate and quantify the virus precisely. Also, the overloading of viral filter membrane absorbers may lead to a reduction in the binding capacities and cause low filtration rates. It can lead to the leakage of viruses and make it challenging to achieve targeted results.
- Lack of Standardization
Till today, no one-size-fits viral clearance testing approach has been identified. The virus has a diverse nature and mutates easily. Because of this, the validation process may vary between biopharmaceutical companies. Therefore, the lack of standardization in the viral clearance testing process has become the major challenge for the biopharmaceutical companies in the viral clearance validating the process.
Embrace Innovative Technology and Approaches for Viral Clearance Testing
The top viral clearance market players have come up with advanced solutions and innovative technologies to mitigate the challenges faced by companies in the viral inactivation process.
- Outsourcing of Viral Clearance Testing
It is worth highlighting that viral clearance validation requires technology, expertise, additional techniques, and installation costs. Therefore, to overcome this problem, a lot of pharmaceutical companies have taken a shift to outsourcing the viral clearance testing process. Outsourcing the viral clearance testing process reduces financial burden, saves time for the validation process, and gives surety of meeting regulatory standards. The outsourcing viral clearance testing providers provide aseptic laboratories, specialized equipment, and GMP-certified facilities that match regulatory authorization requirements.
- Automation and Data Analytic Software
The implementation of automated software and data analytical tools has accelerated the research and development processes. Similarly, many pharmaceutical companies are leveraging automation and data analytic software for the viral clearance testing process. This not only speeds up the viral clearance validation process but also increases efficiency throughput and minimizes the risk of human errors.
- Model Viruses
Model viruses serve as a mock virus model that resembles the structure of the virus you need to clear in the validation process. The mock virus model has been introduced into the manufacturing set-up of pharmaceutical companies to determine the efficacy of the viral removal procedure. Since they are non-pathogenic, these viruses allow researchers to work safely and study the inactivation process of the viruses. Moreover, regulatory bodies such as the EMA and the FDA also required mock virus models in the process of viral clearance studies. This can be a perfect solution to optimize the scale-down manufacturing process and perform viral clearance testing.
Recent News and Developments in Viral Clearance Market
The current viral clearance market is moving to signing strategic partnerships to meet the current demand for viral clearance testing procedures. Some of the recent news and developments associated with the viral clearance market include the following:
- In June 2023, Texcell announced the opening of a viral clearance testing facility in North America in order to improve the viral safety of medical devices and biotherapeutics.
- In June 2023, Valo Therapeutics entered into a collaboration with Texcell to investigate immune responses to PeptiCRAd-1 in their phase 1 clinical study.
Viral Clearance Testing: The Future of Fundamental Validation of Therapeutics
Overall, viral clearance testing is an integrated approach that requires technical regulatory, scientific expertise, and operational aspects. Currently, the viral clearance market players are addressing the challenges and bringing strategic opportunities followed by the adoption of artificial intelligence and outsourcing services. With ongoing advancements and technology adoption, it is anticipated that the viral clearance testing market will grow in the future.
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