The healthcare sector is witnessing rapid evolution. Analytical testing plays a crucial role in this rapidly changing healthcare landscape. It helps ensure the quality, safety, and efficacy of medical products and treatments. The rising demand for high-quality healthcare solutions has led to analytical testing becoming an essential part of drug development and clinical research.
This blog explores the fundamentals of healthcare analytical testing and its significance. It also sheds light on the key players driving advancements in the field. Continue reading!
Healthcare analytical testing involves a series of laboratory-based techniques. These techniques are used to evaluate the quality, purity, strength, and safety of medical products. Healthcare analytical testing is important at every stage of healthcare. It is used to develop new drugs, run clinical trials, and get regulatory approval. It is also vital to check product safety after they are sold.
Below, we’ve explained the key areas of healthcare analytical testing:
Below, we’ve listed the key providers of healthcare analytical testing services:
Eurofins Scientific
Founded: 1987
Headquarters: Luxembourg City, Luxembourg
Eurofins Scientific is a leading provider of analytical testing services. It offers testing services for various sectors, including food, pharmaceuticals, and cosmetics. The company is known for its expertise in small molecule and biologics testing. In addition to healthcare analytical testing, Eurofins Scientific also provides contract research, clinical research, and biopharma contract development and manufacturing services.
Founded: 1878 (Rouen, France)
Headquarters: Geneva, Switzerland
SGS S.A. offers testing, inspection, verification, and certification services. It is considered a global leader in quality and integrity. SGS SA provides a comprehensive range of analytical testing services for the pharmaceutical and healthcare industries. Their services include raw material testing, finished product testing, and regulatory compliance support.
Charles River Laboratories
Founded: 1947
Headquarters: Wilmington, Massachusetts, USA
Charles River Laboratories is a global company that supports pharmaceutical and biotechnology companies in the development of new drugs and therapies. It also provides services to medical device companies. The company has a strong focus on early-stage drug development. Its analytical testing services include impurity analysis, formulation development, and quality control testing.
Laboratory Corporation of America Holdings (LabCorp)
Founded: 1978
Headquarters: Burlington, North Carolina, USA
LabCorp is a global life sciences company that provides a wide range of clinical laboratory and drug development solutions. It supports doctors, hospitals, and pharmaceutical companies by offering diagnostic testing, which aids in informed healthcare decisions. The company also delivers testing services directly to patients worldwide. Its analytical testing expertise includes bioanalytical studies, biomarker evaluation, and pharmacokinetic research.
IQVIA
Founded: 1982
Headquarters: Durham, North Carolina, USA
IQVIA is a global supplier of analytics, technological solutions, and contract research services for the life sciences sector. Its testing services for analysis include bioanalytical testing, clinical trial assessments, and data management. Some of the products offered by IQVIA include Information Management, Pricing and Market Access, Performance Management and Insights, Orchestrated Analytics, and Next Best Action. It also helps businesses drive meaningful changes and create a positive impact on the healthcare industry.
Below, we’ve explained to you the common techniques used in healthcare analytical testing:
Chromatography: This technique helps separate different substances in a mixture, allowing them to be studied individually. In healthcare, it's commonly used to verify that a drug is manufactured correctly. Chromatography also helps spot unwanted impurities. Two widely used forms are high-performance liquid chromatography (HPLC) and gas chromatography (GC).
Mass Spectroscopy (MS): Mass spectroscopy is often paired with chromatography. It identifies substances by measuring their mass and electric charge. The technique is highly precise and can detect even tiny amounts of impurities. It’s used for studying complex molecules, such as proteins or metabolites.
Microbial Testing: Microbial testing ensures that medicines are free from harmful bacteria, fungi, or other microorganisms. It involves counting and identifying microbes to confirm that products meet stringent safety and sterility standards.
Molecular Diagnostics: These tests examine genetic material to diagnose diseases and monitor the effectiveness of treatments. Molecular diagnostics can also track how a patient might respond to certain therapies. Polymerase chain reaction (PCR) and next-generation sequencing (NGS) are key technologies in this area.
Spectroscopy: This set of techniques uses light or magnetic fields to reveal the structure and composition of molecules. For example, UV-Vis spectroscopy measures how compounds absorb light. Similarly, nuclear magnetic resonance (NMR) spectroscopy supplies detailed information about molecular structures.
Like any other field, healthcare analytical testing has its own unique set of challenges. These include:
Complex Regulatory Landscape: Pharmaceutical companies operate in multiple countries. Each of these countries has its own rules and standards for testing and approvals. Staying updated on frequent regulatory changes and ensuring compliance with regulations in all countries significantly increases the complexity and costs of pharmaceutical companies' operations.
Data Management and Security Concerns: Analytical testing produces high volumes of data. Companies rely on advanced systems, such as Laboratory Information Management Systems (LIMS), to store, organize, and analyze this data effectively. At the same time, they must ensure robust cybersecurity measures to protect sensitive information and proprietary data from breaches or cyberattacks.
Healthcare analytical testing is a key aspect of analytical testing. It ensures that the drugs and treatment we rely on are safe and effective. With the growing complexity of biopharmaceuticals and the rise of personalized medicine, the need for analytical testing continues to increase. Companies offering healthcare analytical testing are leveraging advanced technologies to cater to the diverse testing needs.