TotalLab is a specialist software developer for biotech, pharmaceuticals, and life science industries, boasting over 20 years of experience. TotalLab offers advanced software services for equipment manufacturers, bespoke solutions for life science companies, and off-the-shelf products to tackle scientific challenges, automate workflows, and enable FDA 21 CFR Part 11/GMP regulatory compliance. Totallab provides the following software:

Phoretix 1D Phoretix Array Phoretix Colony Phoretix Toolbox CLIQS 1D Pro SameSpots SpotMap
PhoretixArray

A complete solution for calculating anti-HCP coverage using 2D gel electrophoresis and Western blot images

During biopharmaceutical development and manufacturing, host cell protein (HCP) impurities must be carefully identified and monitored to guarantee patient safety, drug efficacy and achieve FDA/EMA approval for your biotherapeutic. Two-dimensional gel electrophoresis (2D, 2-DE) and Western blotting remains the gold standard for anti-HCP coverage characterisation, validating an anti-HCP antibody requires a polyclonal antibody mixture with broad reactivity against the diverse HCPs that may emerge during the production process. To do this, SpotMap allows you to compare images of a 2D gel or blot of proteins detected with an anti-HCP antibody against an image revealing all potential HCP antigen proteins and calculating the coverage percentage between the two.
SpotMap provides the complete solution for analysing HCP coverage with 2D gel electrophoresis and Western blot images.
  • Universal. Supports all industry-standard image formats, including TIFF, GEL, MEL and IMG files. It also supports single stain, DIGE and DIBE techniques.
  • Speed. Get a coverage % in less than 10 minutes.
  • Objectivity. Unmatched automation reduces the need for manual intervention.
  • Reproducible. Evidence of consistent coverage results between different users and labs, drastically reduce subjectivity in your analysis.
  • Quantitation. Enables reliable, accurate quantitation of gel and blot images.
  • 21 CFR/GMP-compliant Meet FDA 21 CFR part 11/EU Annex 11/GAMP5/ALCOA compliance for regulated labs, from captured image through to final analysis and report production.
Our SpotMap software first launched to market in 2015 and is the industry-leading software for host cell protein (HCP) antibody coverage analysis in the pharmaceutical industry. SpotMap is unique and easy-to-use software specifically designed to automate as much of the process of antibody validation as possible for use in high-throughput industrial applications.
The software has been developed in line with and in response to pharmaceutical industry feedback, it is easy to master, with accurate results obtained quickly and reproducibly.

Why do I need to know my HCP coverage?

SpotMap is designed to help users analyse anti-HCP coverage – the percentage of immunodetection that an antibody reagent covers for the total population of HCPs within a sample. It does this by comparing a 2D gel or blot image of proteins detected with an anti-HCP antibody (your secondary image) against an image stained to reveal all possible HCP antigen proteins (your primary image).
HCP coverage analysis is used for:
  • Development of analytical methods (choice and validation of immunoassay reagents)
  • Selection and validation of the most appropriate generic HCP ELISA kit
  • Bridging studies to support assay replacement (e.g. change from commercial assay to platform assay or process-specific assay)
  • Generic assay re-validation for every new batch of reagent
  • Process- and platform-specific assay revalidation after changes that could affect HCP composition
  • Optimization of bioprocesses
The U.S., European and Japanese Pharmacopoeia all specify the use of 2-D gel electrophoresis followed by Western blot analysis (2-D Western blotting) as the gold standard for orthogonal anti-HCP antibody characterisation to evaluate anti-HCP antibody coverage:

Optimise your host cell protein analysis workflow

We use intuitive, automated algorithms and an easy-to-use interface to enable users to obtain an accurate coverage percentage in around 10 minutes.
This enables users to achieve extremely reproducible antibody-to-host cell protein coverage, even between different users and labs. It provides reliable, accurate quantitation of gel and blot images so that you can achieve objective results.
Users are also able to verify host cell protein antibody reactivity, giving you a more complete understanding of the antigen quality.
If you’re looking for software to support HCP coverage analysis, make bioprocess improvements or achieve analytical development then request a free demo of SpotMap. You’ll receive guidance on how to achieve reproducible results, tips for aligning challenging gels and Western blots and knowledge on the software tools to use on more challenging images, such as faint spots.

Every Quadrant Counts

SpotMap allows users to automatically divide their 2D gels or blots into quadrants, to further break down anti-HCP antibody coverage%into areas of low pI low MW, low pI high MW, High pI low MW and High pI High MW. This is especially useful for bridging assays between different lots of anti-HCP antibodies in the generation of process-specific ELISAs to ensure that both antibodies have a similar specificity across the range of host cell proteins, not just the same coverage based on spot number.
Quadrants are part of the innovate “spot sets” feature that allows users to customise their own unique groups of spots for easier analysis on their own (get a coverage score for a sub-population of spots for example) or they can choose one of the automatically created groups based on their current spots:

    * Quadrants
    * High/Low spots
    * Left/Right spots comparison
    * Overlapping spots
    * Top 100, 50, 10 spots based on either volume or area

Amongst many others. Using spot sets makes working with (and reporting coverage scores) on even large numbers of 2D spots much easier and quicker.

Report with confidence

  • Automatically generate a comprehensive report of your entire analysis, including original images, summarising all essential quality control checks, analysis parameters, results, images, tables and coverage charts in a single document. A detailed spot measurements table can also be appended to your report
  • Easily visualize and export critical analysis parameters such as position of alignment vectors and spots that were excluded or edited
  • Save, print or copy to clipboard all project data, tables and images (2D and 3D views, graphical reports, Display area, Application window)
  • Carry out pI/MW calibration to help interpretation of mass spectroscopy-based identification data
FDA 21 CFR part 11 regulations stipulate the need to track, record and authenticate your experiments. With our TotalLab GxP Module, you’re able to control system access, record user activity and define project sign-off procedures to ensure compliance with FDA regulations. 


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