LC-MS Host Cell Protein (HCP) Analysis Software | SpotMap MS
Current Challenges in LC-MS based HCP Analysis
- Complex software. Difficult to drive and time-consuming, preventing users from performing the routine calibration and maintenance they need to do to guarantee accuracy within their specific LC-MS equipment
- Software designed for Proteomics. Current LC-MS analysis software is designed for large-scale proteomic use, not for identifying HCPs. It’s over complicated for the task at hand when you really want to answer a simple question – does my sample contain HCPs? and if so, are they dangerous?
- Lack of reproducibility. Other software packages focus on dealing with many different research questions, and to do so require large numbers of parameters. This compromises the reliability of that data as it is too easy for different users to get different answers. SpotMap MS is designed from a “QC first” perspective designed to align with best practices in the field of HCP analysis.
- Lack of automation. Despite the maturity of LC-MS as an analytical technique, data analysis still remains a time-intensive and laborious process. SpotMap MS is designed as a “set it and forget it” solution automating your analysis and dropping you straight into a comprehensive HCP report once completed.
- Very few 21 CFR/GMP-compliant options. The limitations listed above have so far been a barrier to LC-MS’s adoption within regulated environments, with very few manufacturers supporting 21 CFR/GMP-compliance, limiting user choice. SpotMap MS is fully compatible with our AuditSafe software to achieve 21 CFR/GMP-compliance built by the industry, for the industry.
The software has been developed in collaboration with and in response to pharmaceutical industry feedback and the world’s leading experts in HCP analysis from the BEBPA Host Cell Protein Conference of which TotalLab has been a long time supporter.
It is easy to master, with accurate results obtained quickly and reproducibly.
Hands Free Analysis
SpotMapMS is designed to be as automated as possible to fit in with your life and your workflow. This allows you to save as much time as possible when analyzing your LC-MS samples, through advanced “hands-off” automation that allows you to “set and forget” your analysis through to unique upfront data visualization that allows you to make an upfront decision as to whether a dataset is worth investing analysis time into.
There’s also provision for the software to restart analysis at the last place it reached should anything happen to your computer mid operation. No more being chained to your desk waiting for your analysis to finish!
LC-MS Software with Data Quality at its Core
As Scientists, we want to be confident that we are investigating real trends and ensuring our data is of a high standard is central to this. Being warned early about acquisition failures saves users both time and money. SpotMap MS has a strong focus on making data quality checks automatic and easy to to perform. A new, comprehensive method known as the Protein Verification Loop has been developed by TotalLab specifically for SpotMap MS to ensure that your entire analysis is reliable; from raw data all the way to protein quantification.
This kind of process is specifically mentioned in the latest regulatory guidance, USP General Chapter 1132.1 states: “Search engine output should not be trusted implicitly, especially for low-abundance HCPs”. “Manual inspection of peptide-level raw data (XIC trace, MS spectrum, and MS/MS spectrum) should be a routine part of HCP data analysis process”
Our data quality metrics guide user actions, are easy to interpret and ensure that users at all experience levels can be effective software users and HCP mass spec experts without extensive training.
In other words: the methods and experience of an expert in HCP detection via LC-MS is now codified in an application for you to use
Metrics measured using this method can be used in System Suitability Testing, method development and to characterize the behaviour of your HCPs in your mass
Built-in HCP safety-profile Database
Integration with a Host Cell Protein safety-profile database saves users research time and facilitates prioritization of potentially dangerous HCPs. This database has been generated with the latest techniques in AI, evolves over time and is supported with links to the latest research papers for you to double check if the HCPs you’ve identified are critical to you.
Integration with Trendlab
SpotMap MS experiments can be tracked over time with Trendlab, another exciting new product from TotalLab that enables longitudinal tracking of your MS experiments. This extended functionality allows you to:
- Track your system suitability tests before and after each run, maintaining a long term record of your equipment health, setup and calibration.
- Monitor HCP content across multiple runs and observe any changes in HCP content that might indicate issues or changes in your workflow
21 CFR Part 11 and GMP/GMP-compliance
SpotMap MS, along with all TotalLab software, can be integrated into our 21 CFR Part 11/GMP-compliant AuditSafe software to ensure full 21 CFR/ALCOA/GMP/EU Annex 11 compliance for use in regulated industry environments (such as the pharmaceutical industry) where data traceability, accountability, and integrity are critical.
AuditSafe restricts software and data access through secure user sign-ins, granular permissions, audit logs, electronic signatures and image authenticity checks. Click here to find out more.
Full IQ/OQ Validation Packages Available
At TotalLab, we’ve been supporting the world’s largest pharmaceutical companies with highly secure, production-ready versions of our software for over a decade now and enjoy very good relationships across the industry.
We know the importance of properly validated software and how it forms part of your QC journey so we offer a full, in-person IQ/OQ package to accompany the sale of regulated versions of our software
Flexible Licensing Options
At TotalLab we’ve been working with pharmaceutical and academic life science customers for decades, we know that some of our users prefer offline licensing to enhance security within their sites. This isn’t a problem, all TotalLab software can be activated easily either online or offline.
Our licensing system licenses a whole computer at once, with no restrictions on the number of users who have access to the software on that computer.
Licenses can be purchased singularly for one computer or we also offer discounts on multiple license purchases at the same time if you want to cover multiple computers across your site; enabling hybrid working to perform analysis outside of the lab or to allow multiple analyses to happen at the same time.
We can also support enterprise licensing for full site-wide licenses covering large pharmaceutical manufacturing facilities and research facilities at a significant discount vs buying singular or multiple licenses.
We also support Pay Per Use Licensing for those users offering contract services that can then be invoiced to their customers as a billable event, significantly reducing service providers labor input whilst improving the value proposition for their customers.
For pricing and any other licensing related queries please contact us.
How to Purchase
The best way to ensure you’re purchasing the latest version of SpotMap MS with the highest level of technical support is directly from us here at TotalLab by using the contact us form. We can accept payment in GBP (£), USD ($) or EUR (€).