LC-MS analysis for vaccines

Regulatory standards and clinical administration require thorough documentation of quality attributes about drug product identity, purity, potency, stability, and safety. However, the high complexity of novel vaccine products poses a considerable challenge for impurity and product characterization strategies.

Unlike traditional biologics, which are typically manufactured by expressing one recombinant protein in a single cell line, novel vaccines often contain highly heterogeneous protein mixtures from multiple sources. This complexity means traditional analytical methods such as ELISA often provide insufficient HCP coverage for novel or complex vaccine products. Traditional biologics also have well-defined manufacturing processes, whereas the manufacturing processes for novel vaccines are often still in development.

LC-MS provides a complete overview of your sample(s) regardless of host systems and sample types, from early harvest samples to cleaned-up clinical batches. This enables data-driven process optimization for product consistency and quality and allows you to meet regulatory requirements for product release and characterization.

An Alphalyse mass spectrometry-based assay identifies and quantifies proteins in all sample types and expression systems regardless of their source, even if they originate from several host species.

However, to ensure the safety of our laboratory staff, viral particles must be attenuated or killed before sample shipment. Vaccine components such as virus-like particles, which may closely resemble native viruses but are non-infectious, may be readily analyzed.

Regulatory authorities often fast-track vaccines that can potentially end pandemic threats to public health. However, developing a process-specific ELISA may require 1 - 2 years for antibody development and assay validation. Even then, there are examples of inadequate impurity detection and clearance in commercial vaccine products, causing patient safety issues.

LC-MS assays are robust, quantitative, highly sensitive, and require only 6-8 weeks to be established and optimized for any biologic product. This can significantly accelerate the development, marketing approval, and commercial biomanufacturing of vaccine products while ensuring the highest levels of product quality and patient safety.

The FDA and EMA have already approved release testing for vaccine products in Phase-III clinical trials based on MS-only HCP analysis data under GMP conditions provided by us.