Analytical services for biologics and therapies
Are you looking to assess the potential impact of process- and product-related impurities on the safety and efficacy of your biologic drug, or gain a thorough understanding of your protein-based therapy? Quantitative mass spectrometry analysis provides the robust and reproducible data you need.
We are experts in mass spectrometry-based analytics for biologic drug development, providing reproducible quantification and characterization of drug products, protein impurities, and drug variants. With 20+ years of protein analysis experience and 10,000 completed client projects, our experts offer exceptional advice and support with a smile.
Let us assist you with:
Protein analysis
for reproducible, quantitative determination of specific therapeutic proteins and impurities
Process development
for reproducible, scalable manufacturing and downstream optimization of biologic drugs and advanced therapies
CMC documentation
to facilitate high product quality, purity, comparability, and regulatory documentation
According to the ICH Q6B guidelines, any impurities in, or molecular variants of, biologic drugs and therapies must be well-characterized.
Clients turn to us for help with analytical help within the following categories:
Analytical services for biologics and therapies
Are you looking to assess the potential impact of process- and product-related impurities on the safety and efficacy of your biologic drug, or gain a thorough understanding of your protein-based therapy? Quantitative mass spectrometry analysis provides the robust and reproducible data you need.
We are experts in mass spectrometry-based analytics for biologic drug development, providing reproducible quantification and characterization of drug products, protein impurities, and drug variants. With 20+ years of protein analysis experience and 10,000 completed client projects, our experts offer exceptional advice and support with a smile.
Let us assist you with:
Protein analysis
for reproducible, quantitative determination of specific therapeutic proteins and impurities
Process development
for reproducible, scalable manufacturing and downstream optimization
CMC documentation
to facilitate high product quality, purity, comparability, and regulatory documentation
According to the ICH Q6B guidelines, any impurities in, or molecular variants of, biologic drugs and therapies must be well-characterized.
Clients turn to us for help with analytical help within the following categories:
Services for biologics and therapies
Analysis of process-related impurities
To ensure process reproducibility and product comparability, include mass spectrometry in your HCP analysis strategy for the identification, characterization, and quantification of individual HCPs of concern.
Use mass spectrometry for enzyme-linked immunosorbent assay (ELISA) coverage and reagent characterization to ensure your ELISA is fit for purpose, and as an orthogonal impurity analysis method to support your ELISA data.
If a generic ELISA is unavailable for your cell line or the time to develop a process-specific ELISA is limited, mass spectrometry (MS)-based HCP analysis is the fastest, most precise, and most convenient solution.
MS-based HCP analysis has high coverage and sensitivity and is customizable to your product within weeks.
Our MS assay is available for full validation following ICH guidelines and is applicable to release testing and commercial production.
Our Services
Product characterization
Product and attribute characterization
To comply with ICH Q6B guidelines, regulatory documentation for new protein-based biologic substances and products should provide structural characterization (including truncations, cleavage sites, and major degradants) and an overview of physicochemical properties.
In addition, comparability and stability studies are required for quality assurance/quality control (QA/QC).
Mass spectrometry enables reproducible, quantifiable intact mass analysis, peptide mapping, and amino acid analysis for product and quality attribute characterization.
Our Services
Examples of biologics we analyze
Recombinant proteins
- Enzymes
- Hormones
- Fusion proteins
Antibodies
- Monoclonal (mAbs)
- Biosimilars
- Bispecific (bsAbs)
Vaccines
- Live attenuated
- Recombinant VLP
- Inactivated
Advanced
therapies
- Adenovirus
- AAV
- Lentivirus
Bacteriophage products
- Process samples
- DS batches
- Phage cocktails
Typical project
Facilitate meetings to define the project scope and agree project proposal
Assign an experienced project leader to your project to fulfill the project objectives, ensure timely delivery, and keep your team updated on progress
Provide reproducible data using advanced instruments and robust workflows, with SOPs in place for all analyses to ensure the highest quality
Follow up the report with an online meeting to review the results and answer your questions
FAQ
Alphalyse has cracked the code for reproducible LC-MS analysis using pipetting robots for automated sample preparation, intact protein standards for quality control, and big-data analysis to monitor variation. This allows us to perform robust, quantitative, and reproducible LC-MS analyses in accordance with regulatory guidelines.
Alphalyse scientists work with various biologics and sample types, giving us broad experience from multiple projects, which we share (confidentially) with our clients. We have completed 500+ HCP projects, and our 30 employees work exclusively on LC-MS analysis for process- and product-related impurities - constantly seeking to improve our methods.
The FDA and EMA increasingly demand HCP analysis orthogonal to ELISA data. Alphalyse clients have had BLAs, INDs, and even release tests approved based on our LC-MS data.
No other lab has completed as many LC-MS-based HCP projects as our experts. We focus exclusively on HCP analysis and protein characterization and have made it our signature to deliver personal and professional advice throughout client projects.
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.