How Bioanalytical Services Are Transforming Drug Development and Research

Bioanalytical Services

Cost-efficient and high-quality bioanalytical solutions are critical for accelerating drug development programs. As the drug development and pharmaceutical industry progresses, the need for sensitive, accurate, rapid, and cost-effective bioanalytical services increases. Bioanalysis services providers offer a complete range of bioanalytical solutions, including but not limited to:

• Method development and validation
• Method feasibility studies
• Method transfer
• Bioanalysis of samples in complex studies such as BA/BE testing, PK/PD analysis, and anti-drug antibody testing
• Bioanalysis to support preclinical and clinical assessments.

The current article discusses the role of bioanalytics companies in transforming drug development and research.

Bioanalytical assay labs: accelerating drug discovery and development

Bioanalytical laboratories develop novel methods for analyzing drug products, including combination approaches for studying multiple analytes in a single assay or double extraction methods. These unique bioanalytical methods generate reproducible, robust, and accurate results. Moreover, these laboratories have a dedicated and experienced team, with bioanalytical scientists and pharmacologists who have expertise in their domains and can conjure innovative strategies to fulfill complex and challenging drug development demands.

Today, LC-MS-based methods are increasingly being employed in drug discovery and development. Bioanalytical services providers are experts at developing novel LC-MS and LC-MS/MS assays for clinical and preclinical studies. However, the validity and accuracy of bioanalytical results depend on successful regulatory compliance. Hence, bioanalytic companies undergo rigorous regulatory inspections for global markets to provide reliable and accurate data supporting drug submissions across multiple regulatory agencies. Most bioanalytical service providers have extensive experience in supporting ANDA and NDA submissions.

The need for novel therapeutics with increased potency and safety has resulted in ultrasensitive methods to detect and quantify low drug concentrations and their metabolites in complex biological matrices. Bioanalytical services providers have an in-house team utilizing advanced state-of-the-art systems and bioanalytical platforms to deliver highly accurate and sensitive results.

One of the most crucial aspects of bioanalytical testing is a client-centric approach that Assay Labs employs to expedite the turnaround period. They specialize in focusing on specific client requirements and provide an efficient and comprehensive strategy to overcome barriers and concerns in bioanalysis. In fact, many bioanalytical service providers have a turnaround time of 48 hours for bioanalysis.

Most experienced bioanalytical laboratories have practical knowledge of hundreds of biomolecules across different technologies. Let us explore the experiences of these assay laboratories in diverse biomolecules.

Biologics

Bioanalytical service providers have expertise in developing multiple biologics. While developing biologics, they primarily focus on understanding the intended application of the assay, potential interferences, unique properties of the target biotherapeutic, reference standards and materials, regulatory requirements, etc. With this information, bioanalytical laboratories design customized assays or adapt pre-existing methods to generate meaningful data and make informed decisions.

Biosimilars

Developing biosimilars requires extensive knowledge, technical capability, experience, and understanding of regulatory requirements. The developmental needs for biosimilar drugs are different and require a unique understanding of the biopharmaceutical compound. Bioanalytical laboratories have in-depth expertise in developing biosimilars. They understand the distinctive needs of biosimilar development, such as:

• Biosimilars should have comparable results to the innovator reference across different product lots.
• Assays used for the innovator product may need modifications or redevelopment as the biosimilar may have different physiochemical properties and functional activity.
• Biologics are inherently complex, and bioanalytical methods may face variability. Bioanalytical service providers have expertise in overcoming variation across operators, instruments, reagents, etc.

Additionally, anti-drug antibody testing and efficacy evaluations are necessary to justify modification from the innovator product. Besides, disease states can impact the pharmacokinetics and pharmacodynamics of the drug product. Not to mention, manufacturing changes may influence the assay results. Bioanalytical labs specialize in meeting all challenging demands in biosimilar development. They understand the competitive nature of biosimilar development and ensure to meet tight timelines.

Cell and gene therapy

Bioanalytical assay labs have worked with multiple clients for cell and gene therapy assays. With deep expertise in PK/PD assessments, immunogenicity evaluations, and molecular genomics, their core team provides extensive solutions in cell and gene therapies at every stage of the development life cycle. Bioanalysis service providers work closely with customers to support multiple delivery mechanisms and analytes, such as:

• mRNA
• Oligonucleotides
• CRISPR/Cas9
• CAR-T therapy
• Enzyme replacement therapy
• Polymers
• Adeno-associated virus
• Lipid nanoparticles
• Targeted delivery mechanisms

Must Read: How PK/PD analysis is used to optimize drug development processes?

Generics

Today, bioanalytical labs are at the forefront of developing generic drug products. Bioanalytical services employ a proactive approach for method development and validation as early as preclinical testing. Along with preliminary and pivotal studies, they offer formulation development. Generic drug development has unique regulatory needs and calls for an experienced bioanalytical partner. Besides, the ANDA submission process has strict requirements. Most bioanalytical laboratories have experience supporting generic development and meeting rapid turnaround times.

In Conclusion

Bioanalytical service providers are the backbone of the drug development and pharmaceutical industry. Biomedical and drug development industries are increasingly relying on bioanalytical partners for customized and rapid solutions. However, clients should identify a laboratory that aligns with their research requirements and desired monetary expectations.