Quality control (QC) testing is paramount in ensuring the efficacy and safety of therapeutic biologics. These complex molecules, derived from living organisms, require stringent testing to meet regulatory standards and ensure patient safety. While state-of-the-art molecular methods have been established, many laboratories still rely heavily on animal testing, using protocols developed in the 1970s.

However, in November 2023, the International Council for Harmonisation (ICH) announced the adoption of its Q5A(R2) guideline on viral safety evaluation of biotechnology products and a guideline on validating analytical procedures. These guidelines encourage the biopharmaceutical industry to adopt new standards in biologics QC, including next-generation sequencing (NGS)-based assays.

The Need for Advanced QC Testing

Therapeutic biologics, such as monoclonal antibodies and recombinant proteins, treat various diseases, including cancer, autoimmune disorders, and infectious diseases. These biologics are highly complex molecules; even minor structural variations can affect their efficacy and safety. Therefore, rigorous QC testing ensures that each batch meets the required standards.

Challenges with Traditional Animal Testing

While animal testing has been the gold standard for QC biologics testing for decades, it has several limitations. Animal testing can be time-consuming and expensive and raises ethical concerns regarding the use of animals in research. Additionally, not all human pathogens can replicate in animals, limiting the effectiveness of these tests.

Embracing Next-Generation Sequencing (NGS) in QC Testing

NGS is a highly sensitive technology that is becoming widely adopted in biopharmaceutical drug development and manufacturing to assess biotherapies’ product characterization and biosafety. NGS allows researchers to analyze the entire genome or specific regions of interest quickly and accurately. In biologics QC, NGS can be used to sequence the DNA or RNA of the biologic, allowing researchers to detect and characterize any potential variations or impurities.

The Role of Regulatory Guidelines

Regulatory authorities are establishing guidelines for biopharmaceutical companies using NGS-based assays, including guidelines for computational systems that support NGS-based assay data analysis within a validated (GxP) environment to ensure product quality, data integrity, and patient safety.

Conclusion

As the biopharmaceutical industry continues to innovate and develop new therapeutic biologics, the need for advanced QC testing methods becomes increasingly important. By embracing NGS-based assays and moving away from traditional animal testing, the industry can ensure the quality, efficacy, and safety of therapeutic biologics while also addressing ethical concerns and reducing costs.

How Astrix Can Help

Astrix specializes in providing outsourced resources to support biopharmaceutical companies with their biologics quality testing needs. Our staffing and consulting solutions have the expertise you need in NGS-based assays and compliance with regulatory guidelines. We have decades of experience supporting companies in adopting new standards in biologics QC and ensuring the quality, efficacy, and safety of therapeutic biologics.

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