Why Analytical Testing Matters in Biopharma

Biopharmaceutical products, including monoclonal antibodies, cell and gene therapies, and vaccines, are inherently complex. Unlike traditional small-molecule drugs, these products are often derived from living cells, making them highly sensitive to variations in manufacturing and storage conditions.

Analytical testing ensures the quality, purity, potency, and stability of biopharmaceuticals throughout their lifecycle, from early development to final product release.

Without rigorous testing, even minor inconsistencies in a product can lead to reduced efficacy, compromised safety, or regulatory non-compliance. By employing advanced analytical methods, biopharma companies can identify impurities, confirm molecular structures, and monitor critical quality attributes (CQAs) that are essential for maintaining product integrity.

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Driving excellence in Analytical Testing

Chemetrix is at the forefront of supporting biopharma companies with advanced analytical solutions. By offering cutting-edge instruments and technologies, we help laboratories address the challenges of testing biologics and other complex products.

We provide access to industry-leading platforms, including HPLC systems, LC-MS, and next-generation spectroscopy tools. These technologies are designed to deliver high sensitivity and precision, ensuring that every aspect of a biopharmaceutical product is rigorously tested.

The new generation Agilent 1260 Infinity III is a robust instrument that delivers the performance, reliability, and robustness you need for the highest confidence in daily HPLC results. With the freedom to mix and match new modules with existing HPLC instrumentation, it’s possible to maximise uptime and minimise disruption while also getting on the fast track to efficiency, optimizing speed and resolution for analysis.

Moreover, Chemetrix offers comprehensive support services, from installation and training to ongoing maintenance and technical assistance. This ensures that labs can maximise the performance of their analytical equipment and stay ahead of industry demands.

📚 Download the Mass Spectrometry of Macromolecules Using Standard Flow LC/MS application note to discover a robust and sensitive LC/MS method using standard LC flow for the analysis of native protein analysis >

The importance of analytical testing in biopharma cannot be overstated. As the industry continues to evolve, the need for advanced testing methods will only grow. By leveraging state-of-the-art technologies and partnering with trusted providers like Chemetrix, biopharma companies can ensure the safety, efficacy, and quality of their products while meeting regulatory expectations. With our commitment to innovation and excellence, Chemetrix stands as a trusted ally for laboratories navigating the complexities of biopharma analytical testing.

Today, the industry for alternative proteins has technology on their side and are continuously turning to data and analysis to find solutions that will make these increasingly popular food items more appealing to a wider consumer base. And while meat or burgers grown in a lab does grab headlines, it’s a far cry from the products found in grocery stores that are more practical and cost-effective. Making better alternative protein products isn’t as easy as throwing lentils into the mix and scientific methods are helping to expand the alternative protein offerings in the mainstream market.

Passing taste tests with lab innovation

As the market for alternative proteins expands, rigorous testing becomes crucial. Ensuring the safety, composition, health benefits, and sustainability of these products is essential for maintaining consumer trust and industry growth. For many consumers, concerns about contaminants like veterinary drugs and hormones in meat products make alternative proteins a preferred choice, perceived as a healthier option. However, with rising demand and sometimes limited supply, food fraud becomes a significant challenge. Fraudsters may substitute expensive plant-based proteins with allergens like wheat or soya, or engage in other deceptive practices such as mislabelling and counterfeiting.

To address these challenges and meet consumer expectations in terms of the sensory experience, food developers are turning to advanced analytical tools. These tools are essential for overcoming the biggest hurdles to mainstream acceptance of alternative proteins: taste and texture.

By using sensitive instruments to analyse and optimise the flavour, aroma, and nutritional profiles of these products, food scientists can ensure they meet the high standards expected by consumers.

The process begins with sample preparation to remove unwanted interferences such as fats, chlorophyll, and pigments, allowing researchers to accurately compare the alternative proteins to their animal-based counterparts. Tools like liquid chromatography and mass spectrometry systems are then used to analyse food on a molecular level. Liquid chromatography provides detailed characterisation of stable components such as amino acids, vitamins, and lipids, while gas chromatography examines volatile compounds to engineer desired smells and tastes.

Ensuring a quality composition of alternative proteins

Agilent’s workflow solutions exemplify the robust testing needed in the alternative protein industry. These solutions validate the authenticity, nutritional information, and safety of alternative protein products. For instance, Agilent’s LC-Q-TOF-MS/MS technology has been used to investigate non-meat proteins and peptide markers in ready-to-cook beef burgers, while GC/MS-based metabolomics approaches differentiate the chemical profiles of plant-based meat alternatives from grass-fed ground beef.

Watch our webinar on Metabolomics Profiling of Meat and Plant-based Meats >

Elemental analysis is another critical aspect of ensuring the quality of alternative proteins. During the production process, there is potential for elemental metals to contaminate the final products. Agilent’s atomic spectroscopy instruments, such as the 7850 inductively coupled plasma mass spectrometry (ICP-MS), enable the identification and quantification of these metal elements, ensuring product safety.

The future of food relies heavily on advancing research into alternative proteins. Technologies such as ICP-MS, triple quadrupole (QQQ) liquid or gas chromatography-mass spectrometry (LC/GC/MS), and high-performance liquid chromatography (HPLC) are recommended for robust testing purposes. These tools not only support the development of safer, healthier, and more sustainable food options but also influence the global food supply chain.

Chemetrix has the expert knowledge and innovative solutions required by the food industry to advance the safety and innovative product development of alternative proteins. As the food and agriculture industry faces ever-increasing demands for more sensitive, productive analytical solutions, Chemetrix leads the industry with products and services to help you deliver what your customers demand. Our instruments, systems, and supplies are used throughout the food production chain, including incoming inspection, new product development, quality control and assurance, and packaging. Contact us to find out how our team can assist you.

Data integrity is a critical aspect in pharmaceutical laboratories, ensuring that the data generated during business operations and drug manufacturing is accurate, complete, and reliable. When data is reliable, business owners can make informed decisions, improve product quality, and contribute to overall success.

Data integrity is important because it builds trust with stakeholders and ensures that the information used to evaluate drug safety, efficacy, and quality is trustworthy. For patients using a pharmaceutical product, it assures them of the safety that is promised and provides qualitative evidence to support the manufacturer’s guarantee.

As W.E. Deming said,

“Without data, you are just another person with an opinion.”

Let’s explore some common myths of data integrity by looking at facts, based on a study of available resources and direct interactions with U.S. Food and Drug Administration (FDA) staff and their consultants.

Myth: All this regulation around data integrity is new

Data integrity has been a concern for decades. The FDA’s focus on it began with 21 CFR Part 11 in 1998. In 2003, after the pharmaceutical industry spent years struggling with the regulation, the FDA released its Scope and Application guidance, clarifying some of the requirements in Part 11. This guidance also included a discussion of the FDA’s selective enforcement strategy based on what the administration was finding during its inspections. In 2010, the FDA announced its focus on data integrity inspections. At that time, however, few people within the FDA were qualified to understand the data integrity aspects of computerised systems. Thus, beginning in 2013, data integrity has been a primary inspection point, and there has been a visible increase in data integrity enforcement across all geographies. In addition, starting in 2014, as a result of those inspections, the FDA has often included the names of hardware and software products in their warning letters and related public information documents in a less than subtle message to the hardware and software makers that the administration expects them to assist customers with data integrity and compliance concerns.

Myth: Data integrity is an IT issue

Success in addressing data integrity relies less on technology and more on fostering a culture, organisation, and mindset conducive to excellence. Key contributors to effective data integrity solutions include a shared vision of data integrity practices and a commitment to continuous improvement. In both paper-based and electronic systems, data integrity issues can arise, each presenting unique challenges and requiring tailored remediation strategies. Many responses to these issues overlook the possibility of such occurrences in paper-based systems, failing to conduct risk assessments or identify areas for remediation. Compliance and best practices must span data generation, transformation, maintenance, accuracy, and consistency. Cultivating the right culture, assembling capable teams, ensuring transparency in data integrity performance, and aligning company goals with data integrity objectives are all essential components of a successful data integrity initiative.

Myth: Only the software needs to be compliant

Software often does not comply with regulations. The software itself is inert; software contains the technical controls to support compliance with the applicable regulations. In addition to technical controls, procedural controls must also be in place. A discussion about procedural controls versus technical controls is often seen in FDA warning letters, particularly when gaps in a system’s ability to support technical controls required by various regulations have been exploited.

A standard operating procedure (SOP), used as a procedural control, can substitute for a technical control as long as:

• People are trained on that SOP

• The SOP is followed

• Adherence to the SOP is confirmed by quality oversight and/or compliance auditing

Often, however, even if SOPs exist, they are not followed, and adherence isn’t properly verified. Consequently, the FDA will demand system remediation to prevent a recurrence of the behaviour. Audit trails within computerised systems are an example of technical controls. The software must be able to generate audit trails that contain all the components the regulations require, and then those controls must be enabled.

Analytical instrument manufacturers are taking compliance and regulations into account with their products. As an example, Agilent is applying critical thinking to redesigning laboratory software to help respond to new regulatory compliance realities. Many systems may generate audit trail reports in printed form, but the new version of the Agilent OpenLAB Chromatography Data System has a built-in tool that allows a user to electronically review electronic audit trails entries. These audit trail entries are organised by type, an online review can be performed, and electronic signatures incorporated.

If data integrity regulation compliance is a necessity for your pharma lab, Chemetrix is able to provide solutions that include instruments and software that can help ensure your data is not only well managed and organised, but kept safe and generated with adherence to all the regulatory guidelines.

Data integrity problems can severely impact business operations, leading to financial losses, legal issues, and damaged reputation. It forms the foundation of for reliable pharmaceutical research, development, and manufacturing and, therefore, should be as error-free and precise as possible. It goes beyond being just a practice; data integrity is the cornerstone of trust and excellence in pharmaceutical labs, paving the way for groundbreaking discoveries and lifesaving innovations.

The crucial role of AI in lab quality control: Today and tomorrow

As laboratories grapple with increasing complexities in research and analysis, the importance of AI technology becomes increasingly apparent. AI is not just a futuristic concept; it is the present and the future of laboratory operations. Today, AI is being harnessed to enhance quality control practices by providing real-time monitoring, predictive analytics, and automated decision-making.

Looking ahead, AI is poised to become the cornerstone of innovation in labs, offering solutions to challenges that were once deemed insurmountable.

Benefits of using AI in lab quality control: Precision redefined

Real-Time Monitoring: AI systems can monitor and analyse data in real-time, providing an instantaneous and comprehensive view of lab processes. This facilitates early detection of anomalies and deviations, allowing for immediate corrective actions.

Predictive Analytics: By leveraging historical data, AI can predict potential issues before they occur. This proactive approach enables labs to implement preventive measures, minimising the risk of errors and ensuring consistent quality.

Automation of Routine Tasks: AI excels at automating repetitive and routine tasks, freeing up human resources for more complex and creative endeavours. This not only increases efficiency but also reduces the likelihood of human error in quality control processes.

Enhanced Data Analysis: The power of AI lies in its ability to analyse vast datasets quickly and accurately. This capability is invaluable in quality control, where precise analysis is paramount for ensuring the reliability of results.

Future-proofing lab operations with AI

As we embrace the current wave of AI applications in quality control, it’s crucial to consider how these technologies can future-proof lab operations and inspire innovation. Integrating AI-driven technologies like machine learning algorithms, robotic process automation, and advanced analytics positions laboratories at the forefront of scientific advancement. Imagine a future where AI not only optimises existing processes but also catalyses the development of novel methodologies and approaches, pushing the boundaries of what is possible in scientific research.

Explore AI for your lab

In the race toward scientific excellence, laboratories cannot afford to overlook the transformative potential of AI in quality control. The possibilities are vast, and the benefits are tangible. To unlock the full spectrum of AI-driven innovations, labs must explore and embrace these technologies actively. The lab of the future is not a distant vision; it is a reality that can be shaped today through the strategic integration of AI in quality control processes.

With more laboratories embarking on the journey toward AI-driven quality control, the call to action is clear – explore the possibilities, discover the potential, and redefine the future of your lab.

To take the first step towards integrating AI into your quality control processes, engage with leading experts and solution providers. The evolution of laboratory operations awaits, and AI is the key to unlocking unparalleled advancements in quality control and scientific discovery.

Pharmaceutical and biopharmaceutical materials have become more sophisticated in life science research across fields (such as cancer research, drug development, vaccines, and quality control in regulated environments). The technology used for the analysis should evolve, too.

This webinar will highlight the benefit of the new Agilent Cary 3500 Flexible UV-Vis spectrophotometer and its capabilities in improving workflows in the pharmaceutical industry.

Speaker

Geethika Weragoda
Application Scientist
Agilent Technologies, Australia

Register and watch on demand >

Speakers

Yanqia Wang, PhD, Application Engineer, Molecular Spectroscopy, Agilent Technologies, Inc.

Dr. Yanqia Wang started working for Agilent Technologies Inc. as a FTIR application Engineer in 2013, providing pre-&post-sale application support. The products he covers from Bench-top FTIR microscopes to various Mobile FTIR spectrometers. Dr. Wang received his PhD of analytical chemistry from Duke University in 2004, doing dynamic IR spectroscopy research. Then he joined Fitzpatrick Center for Photonics at Duke University, doing Tissue Raman spectrometer instrumentation. Since 2007, Dr. Wang worked for Avery Dennison Corp. as a spectroscopist, providing molecular analytical support to the research & development.

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