Vaccines
Are you looking for extensive vaccine characterization of batches, process steps, and residual impurities? Do you want to ensure patient safety, heighten drug stability, and avoid developmental delays or risks to other vital parts of your vaccine development?
Analytical support services are necessary for vaccine stabilization, batch to batch comparison, and assessment of immunogenicity. Using advanced mass spectrometry (LC-MS) analyses suitable for all sample types and expression systems, we can quantify residual agents and Host Cell Proteins (HCPs), confirm your vaccine protein sequence, evaluate post-translational modifications, and resolve the intact mass of your recombinant proteins — all within weeks.
Our quantitative analytical data allows you to understand and control your manufacturing and purification processes, and ensures the highest levels of product quality, purity, regulatory compliance, and patient safety.
On demand webinar
Analyzing vaccine purity – without ELISA
Are you struggling to document that your downstream process consistently produces a safe product? In this webinar, you will learn how to quickly measure and compare residual protein in any type of vaccine.
Our analytical services
Ensuring your biotherapeutic vaccine product is of the highest quality
We perform all our analyses according to the ICH Q6B guidelines – Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. By using robotic automation throughout the sample preparation and data analysis, we guarantee quick turnaround times and the most detailed vaccine analysis on the market. And with more than 400 completed HCP analysis projects in only four years, we have worked with all sample types and expression systems. If your host organism(s) are sequenced, we can identify and quantify every single HCP in your sample.
Our services
Our experts in protein analysis by mass spectrometry can help you in the following areas:
Host cell protein analysis
Assess the presence and potential impact of process-related impurities on your product. Identify and quantify residual proteins at each stage of the downstream process to ensure all impurities of concern can be efficiently removed.
Product characterization services
Gain a thorough understanding of your biotherapeutic product. Optimize your process design and ensure that your product achieves all safety, purity, and potency attributes required by regulatory authorities.
Articles
Ensuring consistency of vaccines is complex. We offer proven technology you can trust and you're in safe hands with our LC-MS experts.
Documenting viral and human proteins in one flexible assay
This developer specializes in immune activators targeting hard-to-treat solid tumors. Using one LC-MS assay, they easily compare impurity levels and quantify viral proteins in and between batches.
Comparing viral protein quantities between AAV batches and drug products
Find out how LC-MS was used to look for problematic Sf9 and AcMNPV host cell proteins in an adeno-associated virus based product.
Orthogonal HCP method for vaccine development and production
Statens Serum Institut (SSI) found that ELISA methods provided limited coverage of HCPs in their vaccine, resulting in a lack of detail and accuracy. They needed an ELISA alternative for HCP analysis.
Insight articles
Whatever ELISA-related challenge or question you may have, we are here to help you solve it. One of our protein analysis experts will discuss the best analysis approach or method for your project by email or online meeting – without obligation.
Documenting viral and human proteins in one flexible assay
Our client specializes in immune activators that target hard-to-treat solid tumors. One LC-MS assay makes it easy for them to compare impurity levels in different batches, and quantify viral proteins.
Comparing viral protein quantities between AAV batches and drug products
Find out how LC-MS was used to look for problematic Sf9 and AcMNPV host cell proteins in an adeno-associated virus based product.
Orthogonal HCP method for vaccine development and production
Statens Serum Institut (SSI) found that ELISA methods provided limited coverage of HCPs in their vaccine, resulting in a lack of detail and accuracy. They were thus looking for an ELISA alternative for HCP analysis.
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We offer customized solutions, contact us to discuss your project.
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What clients say
Senior Manager, Process Development
Clinical-stage biotech company
FAQ
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.
Talk to us
Whatever protein-related challenge or question you may have, we would love to help. Our experts can help you decide on the best analytical approach for your project by email or online meeting - providing advice without obligation.