In-silico modeling is an exciting, new area for many biomanufacturers as it creates the opportunity to reduce wasted experiments, lower costs and accelerate development. However, there are many challenges ahead before it is used effectively and consistently, including different methodologies being applied and the need for data quality.

BioPhorum Development Group’s sponsors highlighted that in-silico modeling is an industry hot topic and so the Phorum based its recent BPDG29 virtual meeting on the subject. This not only confirmed interest in the area but that a structured approach is needed to recognize the opportunities it offers to the industry. More than 140 people attended the meeting across the three days.

The result and output from this meeting? The new In-silico Strategies Workstream was born.

Plans are in place for the first mobilization meeting on 8 September. The next step is to draw on members’ experience and expectations to refine the workstream’s charter and the team’s priority areas for a rich and promising collaboration.

Being a new workstream means there is a lot to discuss, for example:

• Should in-silico modeling replace laboratory experiments or define which ones are best to perform?
• What model to use, why and when?
• How can in-silico models be coupled with in vitro studies?
• How should a model be validated?
• Are there any case studies that demonstrate the benefits of validated models?
• What comes first – the data or the model?
• Is there a toolbox of validated models that multiple companies can share?
• What are the blockers/success factors for developing new models?

“During the BPDG29 conference, it was becoming more apparent that many companies are dealing with the same challenges around in-silico modeling, e.g. model setup, lifecycle and validation,” said Dr. Joschka Buyel, Protein Purification & Documentation Expert at Bayer.

“Being able to share your approaches and thoughts on in-silico topics with other scientists around the globe will be an excellent opportunity for establishing new standards and grow as a biotech industry. The in-silico workstream will be a great addition to BioPhorum where we can leverage the strength of our community once more.”

Benefits and challenges

These debates and questions will drive hugely important workstream discussions, with the results ultimately improving bioprocess development – because a ‘right first time’ approach applies to a wide variety of processes, such as chromatography, mechanistic mixing, mechanistic separation and cost predictions.

In-silico modeling creates computerized simulations that can be used to run experiments virtually and help scientists to design more efficient studies or make more efficient decisions for understanding the biological effect of molecules in the body.

This virtual approach means potential benefits include considerably fewer resources needed for ‘design of experiment’ activities, dramatic improvements in ‘right first time’ results, conducting simulations to replace wet laboratory experiments and reducing development lead times.

However, the benefits, approaches and uses of in-silico modeling all depend on the stage of development and, as it is a relatively new area, the approach faces some important challenges. These include:

• A diverse use of methodologies throughout the industry
• An evolving modeling lifecycle and its impact on understanding the model/process
• The need to validate the digital model and justify its use from a business perspective
• Models are limited by the information/data used to inform it, i.e. ‘trash in = trash out’
• The ability to target experiments with the potential to replace wet laboratory work with in-silico models for regulatory filings, but this will require increased industry confidence in the models.

Many companies are uncertain about how to develop and use in-silico models. The new In-silico Strategies Workstream is a fantastic and timely first step to bring together subject matter experts and help define a future direction for the industry. Watch this space.

For more information about the new workstream and how to become a member, please contact nadine@biophorum.com