The Changing Analytical Landscape

Analytical testing forms a vital part of the development lifecycle of bio/pharmaceutical drugs as it provides assurances of the safety and effectiveness of the products prior to patient use. As industry focuses on more complex molecules, growth within the analytical testing services sector is inevitable. In fact, according to recent market research, the sector is expected to experience compound annual growth of 11.4% between 2022 and 2027 (1), largely driven by the swell of biologics and biosimilars in development.

Another aspect altering the analytical testing landscape has been the COVID-19 pandemic, which significantly boosted demand for clinical services as numerous companies raced to develop safe and effective vaccines and medicines to treat the disease.

Since the start of the COVID-19 pandemic, there has been a greater level of investment into analytical testing and services, points out Kishore Hotha, vice president, Global Head of Analytical Research & Development at Veranova.

“The shift to remote work has also impacted the industry, prompting the development of remote analytical testing technologies to support remote operations,” Hotha adds. “Moreover, the pandemic has accelerated the utilization of artificial intelligence (AI) and machine learning (ML) in analytical testing. These technologies offer automation, improved accuracy, and efficiency in testing processes while enabling the identification of potential drug-related issues. Additionally, there has been a heightened emphasis on personalized medicine, which involves tailoring drugs and treatments to an individual’s genetic makeup and medical history.”

In terms of identifying genetic markers associated with diseases and targeted therapies, Hotha feels the changes should persist in the post-pandemic era, as the pharmaceutical industry develops novel drugs and treatments to address unmet patient needs. “Overall, the COVID-19 pandemic has therefore catalyzed advancements in analytical testing, promoting innovation and enhancing the industry’s ability to deliver safe and effective pharmaceutical solutions,” he says.

New testing processes

A prime example of innovation that is helping to expedite testing processes is the rising use of robotics and AI, according to Hotha. These kinds of technological advances benefit both the patient and the pharmaceutical company when utilized properly.

“Labs are implementing new processes in analytical drug testing to enhance safety, efficacy, and efficiency. These include using robotics for automated tasks, cloud-based data storage and analysis, AI, and machine learning (ML), and personalized medicine approaches,” Hotha says. “Robotic systems automate tasks like pipetting and centrifugation, improving accuracy, efficiency, and cost-effectiveness. Cloud-based systems enable seamless data sharing and collaboration, enhancing testing accuracy and efficiency while facilitating the development of novel methods. AI and ML aid in developing new testing techniques, identifying potential drug issues, and improving result interpretation.”

In the case of personalized medicine, testing needs to be individualized to the patient, taking into account genetic makeup and medical history, specifies Hotha. “[Automated] processes foster safer and more efficient drug development, making testing more affordable and accessible. Labs can accelerate testing, improve accuracy, and reduce costs by leveraging automation, data-driven analysis, and tailored approaches,” he emphasizes.

Efficiency: cost versus development time?

For Hotha, analytical drug testing services continue to be highly beneficial for pharma companies, particularly in the face of emerging trends in the industry. He explains that the increasing demand for personalized medicine, which focuses on tailoring drugs and treatments to individual patients based on their genetic makeup and medical history, has created a significant need for robust analytical testing.

“These services play a crucial role in identifying genetic markers associated with various diseases, enabling the development of targeted therapies,” Hotha comments. “Furthermore, there is a growing emphasis on safety and efficacy in drug development. Analytical drug testing services ensure that drugs are safe and effective before administering them to patients. They help assess pharmaceutical products’ quality, purity, and stability, ensuring that they meet regulatory standards and minimize potential risks.”

In addition, researchers are working on treatments for more intricate diseases, which is leading to an increasingly complex drug development landscape, Hotha continues. “Analytical drug testing services play a vital role in unraveling the complex mechanisms underlying these diseases and aiding in developing effective treatments. Through advanced analytical techniques and data-driven approaches, these services enable scientists to gain insights into the intricate aspects of drug behavior and optimize their therapeutic interventions,” he says. “Analytical drug testing services remain indispensable for pharma companies to develop high-quality, targeted therapies that meet the evolving needs of patients and regulatory requirements.”

The impact of CDMOs/CMOs

Contract development manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs) are a major component to vaccine and therapy development, as well as fill/finish operations, toxicity testing, and cost control. In terms of analytical testing, CDMOs/CMOs are hoping to enhance their testing services and make the changes necessary to do so, according to Hotha.

Hotha points out that there are some fundamental approaches to improve efficiency, accuracy, and customer satisfaction, including investment in advanced technologies, expanded testing capabilities, focus on quality systems and compliance, and collaboration/partnerships. For example, expanded testing capabilities hope to cater to broader client needs, he reveals.

In terms of collaboration and partnerships, Hotha adds that specialized testing laboratories collaborate well with CDMOs/CMOs. “Collaborations enable CDMOs/CMOs to offer comprehensive solutions and access a broader range of testing services, contributing to their competitiveness,” he says.

“Success for CDMOs/CMOs in the testing services realm is achieved through a combination of factors,” Hotha continues. “A robust infrastructure, skilled personnel, adherence to strict quality standards, and customer-centricity are critical. CDMOs/CMOs consistently deliver high-quality testing services within defined timelines and budgets and tend to excel in the industry. Flexibility and adaptability in tailoring testing services to meet specific client requirements are highly valued. These strategic initiatives enable them to provide comprehensive, reliable, and customer-centric testing services, positioning them as preferred partners in the pharmaceutical industry to transform molecules into medicines.”

Testing variances

Testing can differ depending on the size of the molecule and the phase of development. The variances may also be based on the drug’s nature, therapeutic area, regulatory guidelines, and individual company strategies. Therefore, flexibility and adaptability in testing methodologies are critical to meet the specific needs of different molecules and development stages.

Large-molecule testing, involving biologics like proteins and antibodies, present more complex challenges than small-molecule testing, according to Hotha. “Large-molecule analysis requires specialized techniques such as mass spectrometry and nuclear magnetic resonance spectroscopy for structure and composition identification. Sample preparation for large molecules is more challenging due to their instability and susceptibility to degradation, necessitating specific preservation methods. Data analysis for large-molecule testing is also more intricate, as these molecules often have multiple subunits with varying biological activities,” he explains.

As for early phase versus late-phase development, Hotha emphasizes how different the testing requirements can be in each phase. “In early-phase development, the focus is on safety, toxicity, and dosage optimization. Analytical methods concentrate on identifying and characterizing drug candidates, stability assessments, and early safety evaluations using qualified analytical test methods with minimum requirements,” he adds. “Late-phase development involves comprehensive testing to meet regulatory safety, efficacy, and quality standards. This includes extensive validation, impurity profiling, stability studies, and method transfer/validation for commercial production.”

The future of analytical drug testing services

In Hotha’s opinion, the future of testing services holds significant promise for the pharmaceutical industry, with new analytical methods of technologies and more collaborations among analytical testing labs with other stakeholders and pharmaceutical companies to further improve the accuracy, efficiency, and reliability of drug testing. “Improvements in technology, automation, and data analytics will enhance the speed and precision of testing processes, leading to quicker turnaround times for results and faster decision-making in drug development,” he summarizes. “Integrating advanced analytical techniques such as mass spectrometry, high-throughput screening, genomic analysis, and imaging will provide a comprehensive understanding of drug properties and mechanisms of action. This knowledge can drive the discovery of new therapies and the optimization of drug formulations.”

Reference

1. Markets and Markets. Healthcare Analytical Testing Services Market by Type (Biomarker Testing, Stability Testing, Raw Material Testing, Batch-Release Testing, Cleaning Validation), End User (Pharmaceutical Companies, Medical Device Companies, CRO), and Region—Global Forecast to 2027. Market Report, December 2022.

About the Author

Jill Murphy is an editor for Pharmaceutical Technology.