The term “biomarker” first appeared in a 1947 paper on fetuin-A detection. Biomarkers are defined characteristics measured as indicators of normal biological processes, pathological processes, or biological responses to exposure or drug intervention, including therapeutic interventions. They serve as early warning indicators of organism damage, reflecting changes in cellular molecule structure and function, biochemical metabolic processes, physiological activities, and changes in individuals, populations, or ecosystems. Biomarkers can include small molecules, proteins, cells, histologic, radiographic, or physiologic characteristics, such as blood pressure changes, blood lactate levels post-exercise, and blood glucose levels in diabetic patients. Specific changes at the molecular level in DNA, RNA, metabolites, or protein content can also be biomarkers.
Categories of Biomarkers
According to the BEST (Biomarkers, Endpoints, and other Tools) guidelines released in 2016 by the U.S. National Institutes of Health (NIH), biomarkers fall into several categories: safety biomarkers, diagnostic biomarkers, susceptibility/risk biomarkers, prognostic biomarkers, response biomarkers, predictive biomarkers, and monitoring biomarkers. For instance, serum creatinine can be used as a safety biomarker for nephrotoxicity monitoring, while blood sugar or HbA1c can be diagnostic biomarkers for Type 2 diabetes.
The Role of Biomarkers in Drug Development
Biomarkers play crucial roles throughout the drug development process, from discovery to commercialization. During drug discovery, they assist in target selection and elucidating mechanisms of action. In preclinical stages, biomarkers are used for dose selection, safety assessments, and further understanding of drug mechanisms. Clinically, they aid in diagnosis, patient stratification, selection, dose optimization, pharmacokinetics, safety, and efficacy assessments. In the commercialization phase, biomarkers are used in companion diagnostic kits, clinical safety monitoring, efficacy monitoring, and drug quality control.
In 2004, U.S. regulatory authorities highlighted biomarkers as key to enhancing drug development efficiency in the white paper “Innovation or Stagnation: Challenge and Opportunity on the Critical Path of New Medical Products.” Biomarkers improve decision-making in drug development, influencing drug dosing, treatment duration, experimental design, risk/benefit ratios, clinical translation, and precise patient selection. The Biotechnology Innovation Organization (BIO) reported that new drugs developed with biomarker guidance have triple the success rate compared to those developed without biomarkers.
A review by Nature summarized clinical trial failures as often due to incorrect targets, molecules, results, and patient selection, issues that biomarker-guided trials can mitigate. For example, predictive biomarkers for patient stratification help identify patients likely to respond well to drugs while excluding those sensitive to side effects.
Detection Technology for Protein Biomarkers
Protein biomarkers are pivotal in diagnosing diseases and monitoring treatment efficacy. Accurate and sensitive detection methods are essential in this domain. Below, we explore several prominent technologies, each offering unique advantages and limitations.
1. Enzyme-Linked Immunosorbent Assay (ELISA). ELISA is a widely used technique for detecting and quantifying proteins in clinical samples. This method relies on antibodies to bind the target protein, producing a measurable signal, typically colorimetric, fluorescent, or luminescent.
Advantages:
High specificity and sensitivity
Relatively simple and cost-effective
Well-established use in laboratories
Limitations:
Sensitivity is limited compared to newer technologies
Narrow linear range
Time-consuming preparation
Potential for cross-reactivity
2. Electrochemiluminescence (ECL). Platforms like the Meso Scale Discovery (MSD) combine electrochemical and luminescent detection methods.
Advantages:
Multiplexing capabilities for simultaneous detection of multiple biomarkers
Broad dynamic range and high sensitivity
Low background signal enhances accuracy
Limitations:
Requires specialized equipment
More costly than traditional ELISA
3. Luminex Multiplex Assay. This technology employs color-coded beads coated with specific antibodies to detect multiple biomarkers simultaneously in a single sample.
Advantages:
Ability to analyze up to 100 biomarkers in a single assay
Reduced sample volume and time for analysis
Provides quantitative and qualitative data.
Limitations:
Requires specialized equipment and software
Potential for bead cross-reactivity
Complex data analysis
4.Single Molecule Arrays (Simoa). Technologies like the Quanterix platform enhance sensitivity by detecting individual protein molecules using digital ELISA principles.
Advantages:
Ultra-high sensitivity (up to 1000 times greater than traditional ELISA)
Ability to detect low-abundance proteins
Suitable for early disease detection and monitoring
Limitations:
Expensive and requires specialized equipment
Complex assay setup and data interpretation.
5. Automated Microfluidic Immunoassay Systems (Ella). This technology integrates microfluidics with immunoassay techniques for rapid and automated protein detection.
Advantages:
Fully automated, reducing human error and hands-on time
High sensitivity and broad dynamic range
Short turnaround time with results in approximately 1.5 hours
Limitations:
Requires specialized equipment
More expensive than traditional methods.
6. Other Immunoassay Platforms. Additional platforms contribute to the detection of protein biomarkers, each offering unique features:
Singulex: Ultra-sensitive detection, particularly in low-abundance proteins.
Gyros: Uses microfluidic technology for high-throughput and precise assays.
ELISpot: Measures the frequency of cytokine-secreting cells, useful in immunological studies.
Randox: Provides comprehensive multiplex assays for simultaneous detection of multiple biomarkers.
Selecting the appropriate detection technology for protein biomarkers hinges on various factors, including required sensitivity, specificity, throughput, and available resources. Each technology has its strengths and limitations, making it essential to choose the method that best fits the specific needs of the research or clinical application.
Development and Validation of “Fit-for-Purpose” Methodology
Biomarkers serve various purposes in drug development, from exploratory hypothesis generation and internal decision-making to critical clinical decisions. U.S. regulatory authorities suggest a “fit-for-purpose” approach to biomarker method validation. Full validation is required for regulatory submissions affecting safety or efficacy, while less stringent validation may suffice for early-stage drug development.
Challenges in Bioanalysis of Protein Biomarkers
Using commercial kits or self-developed methods for protein biomarkers presents challenges. Commercial kits, though convenient, may lack cost-effectiveness and specificity for clinical applications, necessitating further method development and validation. Key challenges include:
Standard-Surrogate Biomarkers. Selecting appropriate standards is difficult due to differences between endogenous analytes and exogenous standards, necessitating careful evaluation and parallelism testing.
Surrogate Blank Matrix. Preparing standards in surrogate blank matrices requires ensuring similarity to endogenous matrices, often involving complex and costly procedures.
Quality Controls (QCs). QC samples need to mimic real samples, preferably using endogenous matrices. However, ensuring QC samples mimic real samples is challenging; often, scientists can prepare QC in assay buffers with extensive validation.
Parallelism. Evaluating parallelism with endogenous analytes is crucial for method validation. It often involves serial dilutions and comparing the precision between samples in a dilution series within the assay range.
Selectivity. Ensuring selectivity involves testing recovery rates using the subtraction method, with recommended spiking of exogenous standards at significant concentrations.
Stability. Assessing stability is complex due to differences in endogenous and exogenous analytes, with variations in folding and post-translational modifications affecting results.
Multiple Detection. Advanced technologies enable multiplex testing, which requires careful method development and validation to address challenges like cross-reactivity, crosstalk, and batch differences.
A Final Word
By addressing these challenges, the pharmaceutical industry can enhance the reliability and efficacy of biomarker-based bioanalysis, contributing to more successful drug development and personalized treatment strategies.
As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the global pharmaceutical and life sciences industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, advanced therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received an AA ESG rating from MSCI for the third consecutive year in 2023, and its open-access platform is enabling more than 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that “every drug can be made, and every disease can be treated.”
In preclinical drug development, biomarkers are used to quantify drug safety and response. In this blog, we trace the use of biomarkers across this spectrum with tips along the way.
Biomarker analysis is a critical piece of drug development that helps provide a complete picture of how a compound impacts the body, informing decision-making at each step.
In preclinical drug development, the most commonly measured biomarkers are:
Safety biomarkers: Indicate the likelihood, presence, or extent of toxicity as an adverse effect.
Response biomarkers: Show that a biological response has occurred, whether beneficial or harmful, after exposure to a medical product.
For an accurate picture, it’s critical to establish that biomarkers and the test methods used to assess them are fit-for-purpose. A fit-for-purpose biomarker assay is “a conclusion that the level of validation associated with a medical product development assay is sufficient to support its context of use.”
Full validation – the extent to which methods are validated for clinical trials – is not required for discovery and preclinical stages. However, exploratory and translational validation is still an important and extensive step.
Biomarker Selection & Method Validation
To measure safety or response, you need to know to the minute amount how much of the biomarker is in the biological matrix, which means the instrument needs to be extremely sensitive and consistent over time. Validation ensures accurate, usable and reliable data (not to mention regulatory compliance).
There are hundreds of standard validated biomarkers available that drug developers can use out of the box. Selecting the right one is a challenge in and of itself, depending on the complexities of the target disease, the stability of the biomarker, and how relevant it may be over time to the target disease. Custom biomarkers may need to be developed and validated depending on your molecule type and therapeutic area, especially if you’re working with a new modality.
Whether you need to identify a standard biomarker or partially validate a custom method, biomarker analysis doesn’t happen in a vacuum. Here’s how it works across the drug development spectrum.
Discovery Biomarker Analysis
At the earliest stage of drug development, biomarker analysis supports in vitro ADME, discovery pharmacokinetics (PK) and pharmacodynamics (PD), and discovery toxicology. Discovery bioanalysis is typically conducted under non-GLP conditions.
Biomarkers are also used in disease models to facilitate the early drug discovery and lead compound screening. For example, a compound/drug candidate/molecule intended to treat a fatty liver may use a response biomarker such as ALT (alanine aminotransferase) to determine a given compound’s/drug candidate’s/molecule’s effectiveness, laying the groundwork for GLP preclinical testing.
Tip: Reduce your timelines by keeping your compound in a single testing organization (as opposed to transferring your research from one unit to another). When you’re ready to move forward with a lead compound after discovery, you can transition to preclinical testing without missing a beat.
Preclinical Biomarker Analysis: DMPK Testing
Biomarkers are commonly used in drug metabolism and pharmacokinetics (DMPK) testing to help assess drug absorption, distribution, metabolism, and excretion (ADME) processes, as well as their pharmacodynamic effects.
For example, measurement of enzyme activities involved in drug metabolism, e.g., cytochrome P450, can provide insights into the metabolic profile of a drug and its potential drug-drug interactions. Another example is the analysis of drug metabolites in biological samples, e.g., blood, urine, which can provide information about the metabolic pathways and clearance of a drug.
The selection and utilization of biomarkers in DMPK testing depend on the specific objectives of the study and the characteristics of the drug being tested. Biomarkers play a crucial role in optimizing drug development processes, predicting drug responses, and facilitating personalized medicine approaches.
Preclinical testing also involves a series of safety assessment studies that evaluate the potential adverse effects and safety profile of a drug candidate. Ultimately, these studies assess toxicity to help drug developers determine the dose range, successfully submit an IND package, and inform the safe starting doses for first-in-human clinical trials.
During preclinical stage, the safety assessment involves the evaluation of a variety of biomarkers, especially the ones that indicate adverse effects. For example, the amount of cytokines (e.g., IL-1, IL-6, TNF, etc.) is typically assessed when evaluating the safety for drugs designed to harness the power of immune system for cancer therapy. Abnormal increase of cytokines implicates the risk of immunotoxicity and need to be taken into consideration of determine the safety profile of the drugs.
As you move through various toxicology species, biomarkers and methods may need to be redeveloped and revalidated. This is due to the fact that each species may have unique physiological and molecular characteristics to effectively measure and evaluate toxicity. Therefore, biomarkers and methods used in early stages of preclinical testing may need to be redeveloped and revalidated to ensure their accuracy and relevance in later stages of drug development.
Tip: Work with a single testing partner that can optimize and validate biomarkers as you progress through species, saving your program time, money, and headaches.
Final Thoughts: Biomarker Analysis Is an Ongoing Process
From discovery bioanalysis to DMPK testing to toxicology, biomarker analysis plays an important role at every step. Simply put, biomarker analysis is all about quantifying the precise and accurate data you need for your IND application. Developing and validating methods – even when full, clinical validation isn’t required – is a time-consuming and complex task and should not be taken lightly.
When seeking biomarker analysis services, look for a partner that offers more than just a standard package. The truth is every project is different and should be oriented around your specific goals. Your testing partner should have a depth and breadth of expertise across small, large, and new modalities, as well as experience with developing and validating methods to the proper extent based on the requirements of your decision level. While you may be able to use standard biomarkers out of the box, the in-house expertise will prove invaluable as you bring your candidate and methods to different species.
WuXi AppTec has more than 1,000 validated methods — many of which are proprietary in-house methods. These are owned by our lab and, as a result, can be used for sample analysis for anyone, greatly reducing the time and cost of method development. Our experts have extensive experience with biomarker analysis in a range of matrices from a variety of species. The biomarkers we have analyzed cover a wide range of safety and pharmacodynamic aspects, including immune response, hormones, cardiac injuries, a variety of drug targets, and more.
Talk to an expertabout your upcoming project to see how we can help.
As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the pharmaceutical and healthcare industry around the world to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, and cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2022 and its open-access platform is enabling more than 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that “every drug can be made and every disease can be treated.”
Small Molecule Solutions Discover promising small molecule compounds, refine their efficacy and safety properties, and prepare them for IND and NDA submission with WuXi AppTec. With our fully integrated program addressing the bioanalytical, DMPK, and toxicology...
Bioanalytical testing platforms are specific analytical tools that analyze and define the amount of drug molecules in biological fluid. Here is an overview of these platforms and when to use them.
To move from one stage to the next in the drug development process, researchers need to make data-driven decisions by generating highly accurate data through a process called bioanalytical testing, or bioanalysis.
Bioanalysis is the process of quantifying drugs and metabolites in biological matrices, including blood, plasma, and urine. This helps researchers better understand how the drug impacts the body so they can put together a complete regulatory submission. To measure drug safety, response, and immunogenicity, biomarkers and the test methods used to assess them need to be fit-for-purpose.
7 Most Common Bioanalytical Testing Platforms
Bioanalytical testing platforms are the techniques used to run assays and perform quantitative and qualitative evaluation of drugs or biomarkers. There are many bioanalytical testing platforms to choose from, each with its own set of advantages and limitations.
Based on the molecule size, type, and sample matrix, bioanalytical experts can discern which assay platform will work best. Then, they typically use the same testing platform through every stage to ensure high-quality and consistent data.
Here is an overview of common bioanalytical testing platforms for small and large molecules.
#1. LC-MS/MS
LC-MS/MS (Liquid Chromatography-Tandem Mass Spectrometry) is a highly sensitive and specific bioanalytical testing platform that allows for accurate quantification of analytes at low concentrations. It provides valuable pharmacokinetic (PK) and toxicokinetic (TK) information and facilitates biomarker discovery.
LC-MS/MS is one of the most common platforms to use in small molecule analysis. It can also be used for peptides and larger molecules, such as oligonucleotides, with an advantage in multiplex analysis capability. However, large molecules have many more options for quantification that are commonly used.
#2. ELISA
ELISA (Enzyme-Linked Immunosorbent Assay) is a common immunoassay technique that quantifies the presence of specific proteins or antibodies in samples through antigen-antibody interactions. ELISA is the most typical ligand-binding assay platform.
This platform is primarily used to quantify PK, TK, and quasi-quantitative evaluation of anti-drug antibody (ADA) properties in large molecular drug modalities, including:
Peptides
Oligonucleotides
Proteins
Antibodies/ADC
Vaccine/Gene therapy
Cell therapy
ELISA offers sensitive and cost-effective approaches for most large molecule bioanalysis. For more sensitivity, multiplex capabilities, broad dynamic determination range, and other improvements to the ELISA platform, though, you might consider the next option: MSD.
#3. MSD
MSD (Meso Scale Discovery) is an electrochemiluminescence-based assay platform that quantifies the concentration of specific proteins and biomarkers in biological samples at a high sensitivity and broad range. MSD is also one of the most popular platforms for multiplex bioanalysis of biomarkers.
MSD should be used for large molecule bioanalysis, biomarker validation, and PK studies – especially when dealing with low-abundance analytes or complex matrices. The commercially available kit provided by the vendor offers great flexibility to the bioanalytical assay development. However, the availability of specific reagents for certain analytes can be limited, which might require an in-house generation and restrict the applications of MSD.
#4. Luminex
A Luminex assay is a multiplexed immunoassay platform that simultaneously quantifies multiple analytes in a single sample using color-coded microspheres (beads). Luminex is another popular platform for multiplex bioassays.
Luminex should be used for large molecule bioanalysis and is particularly valuable when you need to profile cytokines, biomarkers, and immune responses. Luminex offers high-throughput capabilities and the ability to assess multiple targets in a single sample for a comprehensive view of the biomolecular landscape. Luminex is well-suited for biomarker discovery, vaccine development, and immunological studies. Similar to MSD, various multiplex kits are available and can be customized with the vendor.
#5. ELISpot
ELISpot (Enzyme-Linked ImmunoSpot) is a bioanalytical testing platform used to quantify the frequency of cytokine-secreting immune cells (primarily T cells or B cells) in response to specific antigens or stimuli to assess cellular immune response. This is a valuable platform for vaccine development.
#6. FACS
FACS (Fluorescence-Activated Cell Sorting) is a flow cytometry-based technique that bioanalytical experts use to identify, isolate, and characterize individual cells in a heterogeneous population based on their fluorescent properties.
FACS is a powerful tool for immunophenotyping, cell sorting, intracellular cytokine releasing, and receptor occupancy (RO), which quantifies the binding of therapeutics to their targets on the cell surface. FACS is a great technique for studying cellular behavior and function for vaccine development, cell therapy development, and large molecule applications.
#7. qPCR
qPCR (Quantitative Polymerase Chain Reaction) is a highly sensitive testing platform that quantifies nucleotides by using fluorescent dyes to amplify DNA. It tracks the amplification process in real time, providing immediate data during the reaction.
qPCR is widely used for gene expression analysis and cell-based assays. Together with other platforms based on the same technique – including RT-qPCR and ddPCR – qPCR can analyze drug modality ranges from mRNA, miRNA, and siRNA to AAV et al. gene therapeutics at moderate to low target concentrations.
Conclusion
Selecting the right bioanalytical testing platform for your small or large molecule is a foundational part of your drug development program.
There are common testing platforms that are used for small and large molecules, and hundreds of nonproprietary methods for those platforms are available. However, the right method might need to be developed, especially if you’re working with a new modality. This entire process requires strict regulatory adherence to ensure a method is robust enough to support your regulatory submissions.
To ensure success, work ahead. Developing the right method on the right bioanalytical testing platform takes time. Most drug developers work with a method development and validation partner with regulatory and technical experience. With this support, you can put together a complete regulatory submission with high-quality data – and get one step closer to your first-in-human clinical trials.
As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the pharmaceutical and healthcare industry around the world to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, and cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2023 and its open-access platform is enabling more than 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that “every drug can be made and every disease can be treated.”
To make well-informed decisions about the future of your drug candidate, you need highly accurate and reliable data. Generating such data starts with bioanalytical method development and validation – a precise process that requires support from your testing partner.
Researchers have to make important, data-driven decisions to move from one step of the drug development process to the next. In discovery, the decision is about selecting a lead compound. In preclinical stages, it’s about assessing and optimizing ADME properties and toxicity. Ultimately, these decisions lead you to your IND submission and first-in-human studies.
What Is Bioanalytical Testing & Method Development & Validation?
Bioanalytical testing (also referred to as bioanalysis) is the process of identifying and quantifying drugs and metabolites in various biological matrices. To do this, researchers need to identify safety and response biomarkers that can detect the drug in the body’s system.
But not just any biomarker or identification method will cut it. To ensure data reliability and assay performance, researchers must develop and validate bioanalytical methods from step to step.
While there are hundreds of nonproprietary methods available that researchers can start with, selecting the right fit-for-purpose method can be challenging. Sometimes, the right method doesn’t yet exist (especially if you’re working with a new modality), which means a custom method needs to be developed. After all of that, methods have to be adjusted and validated as you progress through the drug development spectrum.
Following regulatory guidance with method development and validation is key to success, which is why most drug developers don’t embark on the challenge alone. Here are three important qualities you should evaluate when looking for a bioanalytical method development and validation partner.
What to Look for in a Bioanalytical Testing, Method Development & Validation Partner to Make Differences
1. Relevant Regulatory Experience
Developing and validating bioanalytical methods should not be taken likely – the accuracy of your data depends on it.
To underpin this importance, the FDA published guidance for the industry, and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) released M10, a multidisciplinary guideline.
It’s important to work with a partner that understands these guidelines and has a long history with successful regulatory inspections. Look for a bioanalytical testing partner with a comprehensive understanding of the regulations and questions or requests that tend to come from regulatory agencies. This insight will help you better follow guidance and adapt to changes.
#2. Automated Testing Processes
The drug development process is time and resource intensive. Any area you can automate – specifically when it comes to large clinical sample analysis – will save you time, improve accuracy, and boost productivity.
Not all laboratories have embraced or fully incorporated automation into their procedures. Be sure to ask your potential partner for their automation capabilities – the accuracy, savings, and efficiencies can be game-changing.
#3. Central Laboratory Services
Data is at the center of all your decisions in the drug development process. This means the process you follow to generate this data – your bioanalytical process – should also be at the center of your decisions.
So, in addition to the aforementioned recommendations, look for a partner that offers comprehensive central laboratory services. A central laboratory is an operational hub for new drugs and other therapeutic interventions, connecting the sponsor, industry, clinical sites, and testing labs. This ensures there are no risks from transferring samples across locations and is particularly useful for clinical studies.
Working with a central laboratory can save researchers time and money by eliminating the need to work with multiple vendors. A central laboratory partner should offer:
Tailored services that fit your specific project’s needs.
A dedicated project manager.
Expert testing personnel.
A successful record of delivering high-quality and reliable data.
An extensive method library and experience developing new methods.
State-of-the-art testing solutions from preclinical to clinical stages.
Cross-site collaboration and global logistics capabilities.
Although most of the assays performed in a central lab are FDA approved (making method development and validation unnecessary), in some circumstances method verification may be needed.
Conclusion
From DMPK to safety assessment across discovery, preclinical, and clinical stages, bioanalytical testing is a critical part of the drug development process. The organization you partner with to conduct this testing – including developing and validating the right methods to ensure accurate and reliable data – is one of the most important decisions you will make.
Your testing partner should bolster your ability to put together a complete regulatory submission and ultimately lead you to better data and a better path to clinical trials – and the market at large.
Leveraging worldwide expertise, regional flexibility, and the latest technology platforms, the WuXi AppTec Laboratory Testing Division delivers quality results through the discovery, preclinical, and clinical phases. Talk to an expert about your upcoming project to see how we can help.
As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the pharmaceutical and healthcare industry around the world to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, and cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2022 and its open-access platform is enabling more than 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that “every drug can be made and every disease can be treated.”
