The Importance of Biopharma Analytical Testing

In the world of biopharmaceuticals, precision and safety are non-negotiable. As companies work to develop advanced therapies and biologics, the role of analytical testing becomes ever more critical. Analytical testing serves as the backbone of biopharma development, ensuring that every product released to the market meets stringent regulatory standards while maintaining the highest safety and efficacy levels. Chemetrix supports this vital process by equipping laboratories with state-of-the-art technologies to optimise testing workflows and ensure regulatory compliance.

 

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.

📚 Download The Journey to Biopharma infographic to discover streamlined automation and cutting-edge analytics >

 

Key Phases of Analytical Testing

Early development

During the early stages of biopharma development, testing focuses on characterising the biological product and defining CQAs. Techniques such as mass spectrometry, high-performance liquid chromatography (HPLC), and spectroscopy play a central role in these analyses. These tools help determine factors like molecular weight, structural integrity, and glycosylation patterns.

Process development

As manufacturing processes are developed, analytical testing ensures consistency and scalability. Process-related impurities, such as host cell proteins or residual solvents, must be identified and quantified. Additionally, methods like capillary electrophoresis and liquid chromatography-mass spectrometry (LC-MS) are employed to optimise purification steps and ensure process robustness.

Final product release

Before a product reaches the market, it undergoes comprehensive testing to confirm that it meets regulatory specifications. This includes assays for potency, sterility, endotoxin levels, and stability. Modern analytical platforms, such as multi-mode plate readers and automated systems, provide the throughput and accuracy needed for these critical assessments.

 

Trends in Analytical Testing for Biopharma

Emergence of advanced techniques

The biopharma industry is increasingly adopting technologies like LC-MS and next-generation sequencing (NGS) to enhance analytical capabilities. These methods allow for greater sensitivity and specificity, enabling researchers to detect low-level impurities and subtle molecular changes that could impact product performance.

Adoption of automation and AI

Automation is transforming analytical testing, reducing human error and increasing throughput. AI-driven software is also being integrated into testing workflows, enabling predictive analytics and more efficient data interpretation.

Focus on emerging therapies

The rise of cell and gene therapies has introduced new challenges for analytical testing. These therapies require novel analytical approaches to address their unique complexities, such as the characterisation of viral vectors and the assessment of genome editing outcomes.

Regulatory compliance and data integrity

With stringent guidelines from organisations like the FDA and EMA, ensuring data integrity has become a top priority. Advanced software systems with audit trails and robust data management capabilities are increasingly essential in biopharma testing.

📚 Watch the Accelerating Analysis in the BioPharma Laboratory​ webinar to discover biopharma workflow innovations that accelerate the characterisation or pathway profiling in protein work & proteomics research using liquid chromatography Mass Spec >

 

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.

Agilent 1260 Infinity II

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.

 

Innovative Tools for Tackling Quality Challenges in Biopharma Development

Biotherapeutics development requires accurate and robust analytical testing methodologies with dependable separations. Agilent is committed to the biopharmaceutical market and has the initiative to leverage the entire product portfolio, application-specific total workflow solutions, and global presence to deliver the support customers rely on to make trusted decisions. As a trusted supplier of Agilent solutions in Africa, Chemetrix is proud to see customers thrive and advance in their research and development.

With biopharma continuing to grow, there are challenges that naturally arise as part of the sector’s evolution. Here, we explain how Agilent’s products address customer pain points including poor reproducibility and difficulties with instrumentation and methods, with insights from Padraig McDonnell, executive vice president and general manager for the Chemistries and Supplies Division at Agilent Technologies.

The future of biopharmaceuticals looks promising with life-changing treatments, and the field keeps growing, powered by innovative groundbreaking therapies to treat cancer and autoimmune diseases. Advancing these novel biotherapeutics safely in the clinic requires reliable manufacturing and quality control processes.

 

The complexity of biopharma development

The complex heterogeneous nature of biotherapeutics requires accurate and robust analytical testing methodologies with dependable chromatographic separations. Identifying critical quality attributes (i.e., impurities that could impact the product safety and efficacy) is the most difficult step in the implementation of a Quality by Design approach for biopharmaceutical development and production. Defining each product attribute is extremely challenging. Therefore, consistency of product quality becomes even more important.

Download the brochure on Solutions for Biopharmaceutical Critical Quality Attributes >

Some of the key challenges in biopharma development are accuracy, robustness, and reproducibility of the data. It all comes down to speed and efficiency of the workflow. It is important to recognise that several analytical techniques are used as part of a workflow solution. This includes sample preparation, separation detection, and data analysis. Each part of the workflow must work seamlessly with the other components to ensure trusted answers.

Watch the webinar on Laboratory Workflow Solutions: What to expect when you’re away from the lab? >

 

Innovative solutions for quality challenges

Reproducibility is a cornerstone of scientific research, ensuring that results can be consistently replicated to validate findings and advance knowledge. Several factors contribute to this issue, including variability in biological samples, inconsistencies in experimental procedures, and limitations in analytical techniques. Known for their precision and sensitivity, Agilent’s mass spectrometry systems deliver highly reproducible results, essential for accurate biomolecule analysis.

Agilent Intuvo 9000

Liquid chromatography is another critical technique in the biopharma and biotherapeutics industries, used extensively for the separation, identification, and quantification of complex biological samples. However, achieving consistent and reproducible results can be challenging due to the complexity and variability of these samples.

Agilent offers a wide range of high-performance LC columns tailored for different applications, ensuring optimal separation of complex biomolecules. These columns are designed to provide high resolution and reproducibility, crucial for accurate quantification.

Agilent 1260 Infinity II

The systems are equipped with highly sensitive detectors, such as UV, PDA, fluorescence, and mass spectrometry detectors. These detectors provide accurate quantification and detection of analytes at low concentrations, enhancing reproducibility.

Getting the workflow right

With great instruments comes great software. Agilent’s data analysis software integrates seamlessly with their instruments, offering powerful tools for data processing, visualisation, and interpretation. This integration helps ensure that data is accurately analysed and reproducible. These software solutions are designed to maintain data integrity and comply with regulatory standards, supporting reproducibility and reliability in research and development.

Download the brochure on Solutions for Biopharmaceutical Critical Quality Attributes >

Regular customer contact and integrating the voice of customer is really critical to us. It gives us exceptional insight into the scientific challenges our customers face. These insights enable Agilent to put an intentional focus on biopharma, as we continue to develop new products and services that help our customers. Collaboration and cross-functional teamwork have enabled us to deliver new products and workflow solutions that better address customer analytical needs.

The biopharma and biotherapeutics industries face significant challenges related to reproducibility and instrumentation. Chemetrix can assist labs in addressing these pain points with innovative products from Agilent Technologies and comprehensive support, enhancing reproducibility, simplifying instrument operation, and ensuring reliable results. By leveraging advanced analytical instruments solutions, biopharma and biotherapeutics professionals can overcome these challenges, accelerating their research and development efforts and ultimately contributing to the advancement of healthcare.

This article includes information and text originally published by Agilent Technologies

 

Keeping Pace with COVID-19 Virtual Symposium

COVID-19 research and testing methods are evolving every day. Join us for an interactive live event to hear the latest on what leading researchers and labs are doing to keep pace.
You will discover best practices for applying technology to support COVID-19 research, test development, and vaccine and drug development – and how these workflows can be effectively applied toward other infectious diseases as well.

 

Register to access a diverse lineup of speakers and sessions, including:

  • Collaborating in the fight against COVID-19
  • A next-generation tool bench for virology research
  • Keynote presentation: Viral hijacking of cellular metabolism
  • Seahorse XF reveals bioenergetic impact in virology
  • Rapid functional evaluation of virus-neutralizing antibodies and antiviral drugs using multiparametric live-cell analysis
  • Focus on virology: Applications to enable discovery
  • SLIMS: Easier and faster LIMS deployment for COVID
  • Faster in, faster out: Achieve the most efficient analysis of raw material for vaccine production
  • Agilent BioMDS solutions for vaccine research
  • Agilent GC solution for alcohol-based hand sanitizer testing
  • Analysis of alcohol levels in hand sanitizer formulations using Cary 630 FTIR
  • QA/QC of protection masks

 

Agenda

 

Register Here >