Published: 03 Aug 2020

•5 min

•5 min read

•Tony Allman•0

Find the right bioprocess software to address specific user requirements

Providing a single software solution to suit the full range and diversity of all biological cultivations would be an impossible task. A universal solution would be over-specified and expensive for most users, whilst similarly, a basic solution may not provide enough capabilities to suit all needs. This overview explores different user requirements and their best choice of bioprocess software.

1. Levels of a bioprocess software

By its nature, bioprocess software is multi-layered. Different categories of users have layers in terms of the features they need from bioprocess software:

Those users with the basic needs may only require the software features integrated into the bioreactor
Most users will require the extra capability provided by external bioprocess software
Some advanced users may need specific features beyond the standard software package, such as process validation via advanced user management and additional security features.

Levels of Bioprocess Software Artwork.png

2. How do you know which level is best for you and why?

Each choice of bioprocess software level will have its own license and related costs. Upgrading is always an option but getting the decision right the first time is preferable. Creating a User Requirement Specification (URS) will help you to define your specific needs: Divide a list of available features into must have, should have and could have categories, then the different software levels can be compared to your list in an objective way. Other stakeholder’s opinions, budget, timing and futureproofing will also play a part in the decision-making process.

The user categories will now be explored in more detail to provide a better idea of how to get the most from each software level. This will help you decide on initial choices if and when to upgrade and to which level. For many users, the decision will be made by the application and process itself.

3. User types

Basic user

A basic user has no perceived need for specialized bioprocess software. Any modern HMI will have elements built-in for local control, but this will not be as comprehensive as a bioprocess software solution. The advantages of keeping all bioprocess data in one place, including analysis results and message logs, are easy to identify.

Basic requirements include:

Output of process values plus set points and controller status
Display real-time data as text and/or charts
Start and stop batches
Log data for a limited timeframe and archive to external memory
Display alarms and archive to external memory
Export data in Comma Separated Value or Excel file formats
Store used setting and/or recipe files

Standard user

This group can be best described as those whose needs are met by the standard features provided. The fact that many popular features are included in a “standard version” is the reason why it is a clear leader in numeric terms. Although, it is likely that an upgrade will be necessary in the future.

A typical standard user would need the basics plus some combination of the following:

Analysis values (including addition of data post-archive)
Comparison of real-time and archived batches
Export of data over a network
Printing of charts
Connection of peripherals
Calculated values
Time-based control in phases
Simple cascades
Feeding in different steps
Pump timings recorded
Store control sequence files
Multi-vessel logging/control
Connection to third-party devices for mixed installation

Advanced

This category equates to full SCADA software plus advanced features related to the whole bioprocess. The type of features which could be included in this group are

Offers customization possibilities
Multiple set up of batches simultaneously
Full reporting with the output of alarms, recipes, soft sensors and workflows.
Data supplied in real time to other laboratory software packages
Full documentation provided for validation, QC and scale-up purposes
Integration with other software for specific purposes e.g. modelling in Matlab.
Central location for data and meta-data including libraries for organisms, culture media and recipes.
Multi-group planning capabilities

This is aimed at users with a product as an end goal. Data generated in the laboratory will need to be shared for scale-up and may count towards a submission for a product license. The units connected would be the actual production vessels.

Super users

This is usually the domain of industrial users and may tie together research, scale-up and production facilities. Any process for clinical applications will need a range of qualification documents for process validation. Regulatory authorities will also need to access the data. However, some universities and institutes may have large projects which need the same level of co-ordination. The type of features which could be included in this group are

Multi-user with a mix of HMI and software for peripherals to be integrated
May also be multi-user and may be multi-site
Numbers of real-time links in the high tens of units
Well-specified server(s) needed
For use within an industrial or Contract Manufacturing Organization

Summary

This article has explored different layers of bioprocess software how they can be mapped onto the diverse needs of users.

A basic user may be able to manage his bioprocess with a local HMI controller and may not require external software, although they would miss out on advanced automation, archiving and data analysis.
A standard user should be well served by a standard software package by using what is needed for their application and ignoring the rest. This will suit most users, but in order to progress, a future upgrade may be required.
An advanced user package equates to the needs of process validation and working across several groups. The concept of the process is a big element, with many elements defined and stored in libraries within the bioprocess software.
The super-user is a rarest category, involving large projects and customized approach. Multi-group and multi-site operation are the key. As tens of bioreactors may be connected at one time, security and reliability are paramount.

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