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Hercule

Biomanufacturing excellence software platform.

"Every batch you run without structured data capture is knowledge you will never recover. Hercule gives you the data infrastructure that turns your manufacturing history into a competitive asset - starting in weeks, not years." 


Hercule turns the manufacturing data you already generate into a structured, queryable asset, for faster development, automated compliance, and continuous process improvement.


✽  What We Offer

One product, different business tracks. 
On the same data.

1

Automated compliance

 Continuous Process Verification is mandatory, and done by hand it's slow, shallow, and error-prone. Hercule's CPV module gathers all your available data in near real-time, checks every batch against your own rules, and generates review-ready reports, turning weeks of manual work into minutes, with full traceability. It flags missing data and at-risk batches early, so your team can act before a batch is lost and support release with days to weeks gained. Automated CPV can be deployed in weeks, not months.

Built for QA, regulatory and production teams.

2

Develop processes faster

Optimising one unit operation at a time is slow and misses how they interact. Hercule structures what you already know across the whole process and focuses your experiments on the parameters that actually drive quality — its Insights, Model and Optimize modules reveal the key process drivers and even suggest the next experiments to run. The result is a robust, transferable process with fewer runs: We demonstrated up to ~40% shorter development time and lower cost. 

Built for process development and R&D teams.

3

Improve existing processes

The knowledge to improve yield, robustness and throughput is already in your batch data, if it's structured. Hercule surfaces the hidden drivers behind your outcomes, quantifies where the gains are, and recommends concrete, achievable changes, automatically taking your regulatory constraints into account. Teams have found double-digit productivity gains this way, for example +15% for a vaccine manufacturer and ~20% across a multi-site cell-therapy operation, from data they already had. 

Built for MSAT and manufacturing-sciences teams.

35+ processes benefited from Hercule already. Boost your biomanufacturing business: Book a 45-minute call. We'll map one of your processes with you.

Ask for a demo

✽  What We Also Offer

Prefer expertise without the software?

At your service !

Not every team is ready to install a platform, and not every need requires one. If you want to find the value hidden in your data, or simply start structuring it, our data scientists can work with you on a project basis, sometimes drawing on Hercule's own data models and analysis routines behind the scenes, with nothing to deploy on your side. Same expertise, delivered as a focused engagement rather than a product.

Hercule at a glimpse

One platform. Many applications.

Hercule brings solutions for very different persons and teams within a biotech manufacturing company: 

  • Process improvement team
  • Production lead
  • Manufacturing Sciences and Technology (MSAT)
  • Process Development
  • Technological R&D
  • Plant manager
  • C-level

Applications fit for all levels of digital maturity.

Holistic view on biomanufacturing.

Biomanufacturing data are challenging to comprehend because they may relate to :

  • Different stages of process lifecycle, from development to commercial manufacturing.

  • Different IT silos: LIMS, ERP, EMS, SCADA, ... which contain many data types (measures, notes, curves, images, timestamps, ...). Hercule will connect to these data sources, and put them in relation and in context. 

  • Different operations. Preparation, Cell culture, Filtration, Harvest, ...  

At the heart of Hercule is a powerful data model covering more than 200 manufacturing related concepts.

Bonus : Hercule is an on-premise software solution. Your data stay at home!

Hercule Software Modules

Insights: Know your process

If you are responsible for process improvement, if you are new to the manufacturing team, if you have experience but want to confirm intuitions on objective grounds, or if you are developing a new process, this module is for you. The Insights module delivers very useful visualization as well as semi-automated statistics on every measures from your process.

Model : Build digital twins

This module uses advanced Machine Learning routines, but very well grounded into manufacturing business. It will discover what are the key process drivers (initially flagged as CPP or not) of any outcome of interest (such as yield, production lead time, or any possible CQA, ...). And it will do so taking automatically into account regulatory constraints. The produced models are thoroughly evaluated, based on data sciences metrics, as well as business-related metrics.

Optimize : Put models at work, get recommendations for improvements.

This module will put models at work. It makes recommendations about how to reconfigure production lines to improve with respect to any specified endpoint. It will also measure the originality and potential gain of each recommendation. Finally, it will suggest the next round of experiments you could run to improve your processes.

Continuous Process Verification

As a production manager, you want to ensure that operations go smoothly, to speed up batch release, to avoid unplanned maintenance, to stop production of a batch that is doomed to fail. You also need to produce batch release records as fast as possible. All these questions can be addressed by the Continuous Process Verification of Hercule. It gathers all available data in almost real-time and produces useful insights and call-to-actions for every single batch. It also allows you to track data management progress. If a part of the data is not yet available to the system, you will know, and may take corrective actions with the team involved. Insights generated by this module can be exported into editable reports, in order to support batch release, with up to weeks gained in the process!

Datasets: future-proof !

When it comes to AI and modelling, data comes first. AI Act, Good Machine Learning Practice (GMLP), GAMP5 V2... they all require traceability, transparency and thorough evaluation of your datasets. This module allows for complete management of datasets. Select what batch should be included or not, what measures should be involved or not, exclude outliers, some specific values, etc. It also enables validation and storage of datasets as well as datasets audit trails.

Datasets can also be conveniently exported in various formats, so that they can be used within your (second) favorite data science environment (R or Python homemade scripts, JMP, SAS,...).

Data Warehouse: Relevant data model with Hercule-CDM.

QC data are in your LIMS, Raw Material data and batch meta-data are in your ERP, Automation data are in an Historian database (and are even not aware of batch production start and stop), Environment data are in an EMS. Microbiology data are yet in a separate system. How are you going to make these data silos talk to each other? How are you going to consolidate these data for joint analyses? The Data warehouse module of Hercule interfaces all these different systems, to reconstitute a unified electronic batch record into a smart and useful Common Data Model (Hercule-CDM). And it does so in a gentle way: your data silos are left untouched, but push new data in the data warehouse through a standardized API. This data lake can then be used by other modules of Hercule to perform all their data analyses and visualizations. The API can also be used to export datasets for other uses, for example to feed your favorite internal statistical software.

Data Entry Module: digital forms.

Either because you have an already long legacy, or because you start transferring a new process from R&D to production, there might be part of your production activities that are still generating unstructured data (paper form or free-text word reports) or structured but uncaptured data (stand-alone xls files). How can the information contained in these files be part of your data-driven strategy? The Data Entry module of Hercule allows you to progressively (at your pace) replace these legacy elements by structured data that can feed your data analyses just as any other piece of data.

Form Editor

This module is the companion of the data entry module allowing you to work autonomously. Your procedures are tailored for paper-based form at some points and you do not want to start modifying them? No worry, Data Entry module have workarounds to fit into this frequently encountered situation. A second module, the Form Editor will allow to you create, edit, customize your forms.

User management.

Configure roles and access per user and/or per process. Authentication within Hercule can talk to your own authentication server for single sign-on.

New in Hercule V1.4: 
Self-service process builder

Define your bioprocesses directly in Hercule with the new Process Builder — the full ISA-88 structure, in minutes, no spreadsheets and no waiting on us. It's the foundation every other module draws on, now in your hands.