Mastering the Molecule: Analytical Testing in a New Pharmaceutical Era

Analytical testing within the drug discovery, development, and manufacturing pipeline has transformed significantly in recent years.

In response to the outbreak of the COVID-19 pandemic, the pharmaceutical industry redirected its efforts toward developing treatments and vaccines, resulting in a substantial upswing in investments in analytical testing technologies and services. These developments have accelerated the adoption of artificial intelligence (AI) and machine learning (ML) and paved the way for more precise and efficient testing methods.

As the industry continues to see the value in emerging novel modalities, such as antibody-drug conjugates (ADCs), peptides, oligonucleotides, and personalized medicines, analytical drug testing services will continue to be highly beneficial for pharmaceutical companies.

Scientist in lab

Here are are some of the key critical concepts for analytical drug testing that are advancing due to the complex challenges of modern drug development.

  • Artificial intelligence (AI) and machine learning (ML) in Drug Discovery
    AI and ML technologies are increasingly used in drug discovery to identify and characterize new drug candidates. These technologies can predict how different compounds interact with biological targets, saving resources in drug discovery. Analytical testing is essential to validate the results of AI and ML-based drug discovery studies. This testing ensures that the predicted properties of new drug candidates are accurate, safe, and effective for human use.
  • Advanced Therapeutic Modalities
    The rise of new therapeutic modalities, such as antibody-drug conjugates (ADCs), drives the demand for analytical drug testing services. ADCs are complex molecules that require precise characterization and testing to ensure their safety and efficacy. Analytical testing is used to determine the structure, composition, and stability of ADCs. This testing also helps ensure that the ADCs are delivered to the target cells in the body and do not cause any unwanted side effects.
  • Repositioning of Drugs
    Analytical testing is also used to support the repositioning of drugs, which involves using existing drugs for new therapeutic indications. This testing can help to confirm the safety and efficacy of drugs for their new uses. Analytical testing is also used to develop new formulations of drugs better suited for their new indications.
  • Personalized Medicine
    Personalized medicine is a rapidly growing field that involves tailoring drug treatment to the individual characteristics of each patient. Analytical testing is essential to this approach, as it identifies the right drug for each patient and ensures that the drug is delivered in the right dose. Correct analytical testing is also used to monitor patients’ response to treatment and to adjust the treatment plan as needed.
  • Quality and Compliance
    The increasing complexity of drugs, especially biologics, has led to a growing need for stringent quality control measures. Analytical testing ensures the quality and safety of drugs throughout the manufacturing process. This testing helps ensure that drugs meet the required specifications and are impure-free.
  • Continual Innovation
    The pharmaceutical industry is constantly innovating, which drives the need for advanced analytical services. New drug development technologies and approaches require new and improved analytical methods. Analytical testing is essential to keep pace with these innovations and ensure new drugs’ safety and efficacy.

Digital Tools for Improved Accuracy and Efficiency

Analytical drug testing is critical to drug development, from early discovery to clinical trials and commercialization. It is used to ensure drug safety, efficacy, and quality. Traditionally, analytical drug testing has been a manual and labor-intensive process. However, digital tools are revolutionizing the way analytical drug testing is performed. These tools are helping to improve accuracy, efficiency, and productivity.

  • Robotics
    Robots can automate pipetting, dispensing, and centrifugation tasks. This can free scientists to focus on more complex tasks and improve testing results’ accuracy and reproducibility.
  • Cloud-based data storage and analysis
    Cloud-based systems allow easy data access from multiple sources. This can help improve collaboration and data sharing and make developing and implementing new analytical methods easier.
  • AI and ML
    These digital tools can be used to develop new analytical methods, identify potential drug problems, and improve the interpretation of test results. These tools can also automate tasks such as data analysis and reporting.

The use of digital tools in analytical drug testing is still in its early stages, but it can potentially revolutionize how this critical work is performed. These tools are helping to improve accuracy, efficiency, and productivity and make it possible to develop new and innovative analytical methods. Some of the specific benefits of using digital tools in analytical drug testing include:

  • Improved accuracy
    Digital tools can help enhance analytical drug testing accuracy by reducing human errors. For example, robots can dispense and pipet samples more accurately than humans.
  • Increased efficiency
    Digital tools can help improve the efficiency of analytical drug testing by automating tasks and reducing manual intervention. This can free up scientists to focus on more complex tasks and help shorten the time it takes to get test results.
  • Enhanced productivity
    Digital tools can help improve analytical drug testing productivity by making developing and implementing new analytical methods easier. This can lead to the development new drugs and therapies more quickly and efficiently.
  • Improved data management
    Digital tools can help to improve data management in analytical drug testing by making it easier to store, organize, and analyze data. This can help improve the data quality and make it easier to identify trends and patterns.
  • Enhanced compliance
    Digital tools can help improve compliance with regulatory requirements in analytical drug testing by providing a more robust and auditable data trail. This can help to protect patients and ensure the quality of drugs.

Overall, the use of digital tools in analytical drug testing is a promising development that has the potential to improve the accuracy, efficiency, and productivity of this vital work. These tools are already being used in various settings, and their use will likely continue to grow.

Collaborative Approach to Overcome Increasing Multi-Component Complexity in Analytical Drug Testing

The development of new drugs and therapies is becoming increasingly complex due in part to the use of multi-component molecules, such as antibody-drug conjugates (ADCs), oligonucleotides, and peptides. These molecules can be difficult to characterize and test, posing challenges for pharmaceutical manufacturers.

To overcome these challenges, pharmaceutical manufacturers increasingly collaborate with contract development and manufacturing organizations (CDMOs) that can provide various analytical testing services, including those specialized for complex molecules like ADCs, oligonucleotides, and peptides.

In addition to CDMOs, pharmaceutical manufacturers may collaborate with other organizations, such as contract research organizations (CROs) and specialized testing laboratories. This can be helpful to get access to even more expertise and resources.

By collaborating with various organizations, pharmaceutical manufacturers can create a comprehensive and coordinated approach to developing and testing these complex molecules. This can help to ensure the safety and efficacy of these essential new drugs. Here are some of the specific analytical challenges posed by ADCs, oligonucleotides, and peptides:

  • Complex structure
    These molecules are often made up of multiple components, which can make them challenging to characterize and test.
  • Lack of standards
    There are often no standard analytical methods for these molecules, making comparing results from different laboratories difficult.
  • Degradation
    These molecules can be unstable and degrade during manufacturing or storage. This can make it challenging to ensure that they are safe and effective.
  • Bioanalytical testing
    Bioanalytical testing is often required to measure the concentration of these molecules in biological samples. This testing can be challenging due to these molecules’ small size and complex structure.

Pharmaceutical manufacturers can access the expertise and resources they need by collaborating with a CDMO to overcome the analytical challenges posed by ADCs, oligonucleotides, and peptides. This can help to ensure the safety and efficacy of these essential new drugs. The benefits of collaborating with a CDMO for analytical drug testing of ADCs, oligonucleotides, and peptides include:

  • Expertise
    CDMOs have a wealth of experience in the development and testing of complex molecules, such as ADCs, oligonucleotides, and peptides. This expertise can be invaluable in helping pharmaceutical manufacturers to overcome the challenges of analytical drug testing.
  • Resources
    CDMOs have access to state-of-the-art analytical equipment and technologies. This can help pharmaceutical manufacturers to get the testing they need quickly and efficiently.
  • Collaboration
    CDMOs are experienced in working with pharmaceutical manufacturers to develop customized testing solutions. This can help to ensure that the testing meets the specific needs of the drug development program.
  • Compliance
    CDMOs are familiar with the regulatory requirements for analytical drug testing. This can help pharmaceutical manufacturers ensure that their testing complies with applicable regulations.

The collaborative approach between pharmaceutical manufacturers and CDMOs is essential to ensure the quality and safety of ADCs, oligonucleotides, peptides, and other complex molecules. These organizations can pool their expertise and resources to develop and implement the most effective testing methods by working together. This collaborative approach is essential to successfully developing and commercializing these important new drugs.

Managing your complexity with confidence

The pharmaceutical landscape is ceaselessly shaped by evolving trends, influenced by drug characteristics, therapeutic domains, regulatory directives, and tailored company blueprints. Consequently, testing methodologies must espouse agility and resilience to cater to the unique requirements of diverse molecules at various developmental junctures.

The next generation of analytical drug testing services harbors the promise of advancing drug innovation, augmenting patient well-being, and bolstering the pharmaceutical sector’s success. By maintaining a vanguard position in regulatory shifts, pioneering modalities, and avant-garde technologies, CDMOs can guarantee consistent delivery of top-tier analytical methods, reinforcing trust in drug developmental outcomes.

About the author

Dr. Kishore Hotha is the scientific leader at Veranova and serves as the Global Head of Analytical R&D. With a career spanning over 20 years: he has provided scientific business leadership for numerous INDs, NDAs, and ANDAs. Dr Hotha has extensive expertise in developing drug substances and products, particularly in HPAPI, Drug linkers, ADCs, and complex drug dosage forms. He has authored over 40 scientific research publications and serves on several editorial boards. Dr. Hotha received his Ph.D. from JNT University, India, and has held leadership positions at Lupin and Dr. Reddy’s in Research & Development.

Dr. Kishore Hotha

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