Advancing QC for Complex Biologics

Integrating MALS detectors with Empower software is a significant advancement for biopharmaceutical quality control because it combines absolute characterization of identity and purity from MALS with a widely adopted, validated data management platform. Unlike traditional compendial techniques – such as UV detection, which has been reported to miss critical quality attributes like transient low-level aggregates and often misses polydispersity under an eluting peak – MALS provides direct, absolute measurements of both, enabling improved quality testing.

On top of the accessibility to more advanced routine analysis, Empower is already a trusted system in QC labs, with established data integrity and compliance features. By embedding MALS, the resulting data inherits the same level of trust, traceability and regulatory readiness. Additionally, since Empower is already validated in many QC environments, integrating MALS within this system reduces the burden of additional validation.

This integration also aligns with the industry's push for digital transformation, operational efficiency and regulatory robustness. Empower’s enterprise connectivity ensures that data from different instruments and locations are harmonized and accessible. 

Biologics are becoming more complex, and the number of tests used in QC have increased in order to maintain safety and efficacy. This is especially true for the more nascent therapies, where we have heard from customers that they are using 5+ instruments to monitor one attribute to be absolutely certain of its state in the final product.

In addition to the more exotic gene therapies, the diversity of the protein pipeline is also increasing. More conjugated therapies incorporating new linkers and bispecific or even trispecific monoclonal antibodies (mAbs) are in development and quickly moving to QC as companies strive to make more efficacious therapies with less side-effects.

The benefit of MALS is that it is a platform technique, meaning it can be applied across a wide range of product types and can scale with the biotherapeutic pipeline. When diving into the protein pipeline, one of the faster growing classes is the aforementioned bispecific mAbs. While they are promising therapies, their complex structure makes them prone to aggregation and polydispersity.

MALS can deliver the required analytical insights with minimal method development when transitioning between molecules. With Empower integration, innovators can future-proof their workflows by enabling routine, QC-ready analysis for current and upcoming molecules.

MALS integrates seamlessly with existing liquid chromatography (LC) and optical detection systems commonly used in QC laboratories. Positioned 'downstream” from the LC instrument, the MALS detector receives the sample directly after it passes through the UV detector. This highly efficient inline configuration doesn’t require additional acquisition time outside of the compendial tests of LC-UV.

One of the key advantages of incorporating MALS into Empower software is the minimal learning curve. Since many scientists are already familiar with Empower, the time required to become proficient is significantly reduced. We recognize that some learning and method transfer will still be necessary for customers familiar with the ASTRA software from Wyatt, or unfamiliar with the MALS technology.

To support this, we offer premium support through our dedicated informatics professional services team, helping users get up to speed quickly. We also plan to include an introduction to MALS in Empower software as part of our Light Scattering University training courses later in the year.

Additionally, we’ve assembled a cross-trained support team – service engineers trained on both hardware components deployed in the field – who are prepared to assist with installation and answer questions to help users get started smoothly.

QC groups will face increasing pressure to ensure identity and purity of the therapy while maintaining compliance across all analytical platforms, which are likely to grow to adequately address critical quality attributes.

Empower Software is establishing itself as the central hub for QC data, forming the backbone of regulated laboratory operations. As the biotherapeutics landscape grows more complex, the demand for advanced analytical instrumentation and integrated data management will continue to rise. More than just a data repository, Empower does and will serve as a strategic enabler of regulatory compliance and data harmonization of a diverse set of analytical instruments.

The last thing I’d call out here is on how AI/ML can support the rise of complex biologics. In the QC lab, all chromatograms must be reviewed to ensure peaks are correctly integrated. This is a time-consuming exercise for some of the complex chromatograms produced and is an area that our customers have asked for tools to accelerate that process. Empower now offers an AI/ML tool that calls out differences between an integrated chromatogram and a reference library of properly integrated chromatograms. This enables reviewers to focus their efforts on areas of concern, and it can reduce review times from many days to a few hours.