Embracing Analytical Techniques Into Regulated Laboratories

Biopharmaceutical regulations and regulatory guidance help to ensure high performance across the industry, enabling laboratories to create better and more consistent drug therapies. Though the rules around compliance can be complex, they provide the structure for the pharmaceutical industry to succeed in releasing a safe and effective product.

To ensure compliance success in a changing regulatory landscape, laboratories must continually adapt in order to maintain compliance. Biopharma is presented with an additional compliance challenge, as the field requires complex analytical instruments that are not traditionally used in highly regulated labs.

One solution is the utilization of compliant-ready liquid chromatography-mass spectrometry (LC-MS), which can provide mass spectrometry detection for quality control analysis in Biopharma. As a fit-for-purpose, compliant-ready LC-MS system, Waters’ new BioAccord LC-MS platform addresses the biopharma compliance challenge by helping laboratories replace their less sensitive optical-based assays with a more advanced methodology.

How a robust, easy-to-use LC-MS platform can help meet the biopharma compliance challenge

The FDA introduced regulations for electronic records in 1997, giving companies selling products to the United States over 20 years to bring their laboratories to compliance. In this time, mass spectrometry and information technology have evolved dramatically – making it critical for customers to have access to technologies that can help them drive research forward while continuing to adhere to ever-evolving regulations.

Data integrity is of key importance for laboratories, especially those that claim good laboratory practice (GLP), good clinical practice (GCP), or good manufacturing practice (GMP). Maintaining data integrity includes:

• Immediate record storage in which records are attributable, traceable, and unaltered
• Added data controls to ensure that data is trustworthy
• Upon audit, the ability to demonstrate data management methods, integrity, and associated metadata (such as audit trails)

A robust, easy-to-use LC-MS system can help biopharmaceutical drug developers solve the compliance challenge, improve efficiency, and eliminate manual processes – and potential errors and non-compliance issues. For example, a system that manages e-records silently in the background automates data compliance – and ends the practice of tedious and error- or omission-prone handwritten documentation.

Powerful software in an easy-to-use system can handle everything automatically – including documenting the creation and interpretation of scientific data. As the world’s first smart LC-MS system, the BioAccord System differs from those already on the market and is better able to help laboratories address regulatory challenges.

What analysts need to address the compliance challenge with LC-MS

The ability for analysts to have a system that can address the compliance challenge is of great importance. In order for biopharmaceutical organizations to achieve their goals with greater efficiency, they require:

• Easy-to-use systems to achieve goals with greater efficiency
• A simple-to-use electronic record management system
• LC-MS systems with an assured performance both on delivery and throughout use
• To be kept up to date with regulatory expectations

The BioAccord System was designed with customer needs in mind. The system puts usability, deployability, and robustness at the forefront. By empowering our customers to succeed in fields such as Biopharma, where LC-MS has not historically been utilized, the production of life-saving products can proceed more smoothly.

How the BioAccord LC-MS System meets regulated  laboratory’s compliance needs

Usability

The BioAccord LC-MS System is the world’s first smart LC-MS system with an integrated workflow that is reliable, robust, and easy to use. The system fundamentally addresses the need to be more deployable and to allow users who are not familiar with the system to generate high-quality data with confidence in its reliability. The onboard diagnostics are key to helping users who are not familiar with LC-MS technology. These include panels with visual error codes that link to the software and provide step-by-step instructions on how to fix any errors that occur.

Quality of Data

The BioAccord LC-MS System has been engineered to provide high-quality controls that enable confident data retrieval during an audit. The software for the integrated workflow walks the user through the operational steps they need to take in order to reduce human error. The increased automation and reduced interaction help to remove variables relating to unintentional mistakes and ensures the reportable results generated from the instrument are accurate and trustworthy.

The BioAccord System itself works with a foundational platform called waters_connect. Applications on the platform have been developed around the system’s core compliance features. Waters_connect also includes an application programming interface (API) that securely exchanges data from the LC-MS with other best-in-class applications. This can help with compliance and reducing mistakes in situations where you have to use a different application to further process your data.

Instrument Performance

Users require systems that are reliable and robust. Waters dedicates a great deal of time devising qualification tests for LC-MS instrumentation and software so that customers can be assured of analytical performance. Vigorous qualification testing saves customers time and worry about instrumentation issues.

In addition, by offering pre-packaged calibration solutions, we help analysts to easily assess a system’s fitness in the laboratory. Waters’ LC-MS systems can self-calibrate, with quality checks telling users that the system is working to the appropriate level. The self-calibration software makes the calibration process easier, reduces human error, and decreases instrument downtime.

Equipping analysts with transformative LC-MS tools

To develop pioneering advances, users need to be equipped with the right tools. Waters seeks to provide this, and it has been our driving force over the last 30 years. The BioAccord System was designed because of the strong need for a compliant-ready system that leverages advanced technology. It enables scientists to focus on getting the best data possible without having to worry about complying with electronic record regulations.

As technologies like LC-MS move beyond R&D applications such as product and process characterization, the importance of informatics platforms such as waters_connect, and services (training and validation) cannot be denied. By adopting higher performance analytical technologies in regulated areas of pharma development, manufacturing, and quality, users are free to focus on their projects.

Learn more about how the BioAccord System can help your laboratory achieve regulatory compliance and easily leverage LC-MS data to support biopharmaceutical drug product development for the future.