Jeff Breit & Brandon Downey will describe efforts at Bend Research to develop integrated biotherapeutic manufacturing hardware and software technologies to reduce risk and optimize their clients’ fed-batch and perfusion processes. Register here.
1. Why did you decide to do a webinar with us?
We spent some time evaluating webinar vendors and felt that Business Review Webinars offered the right audience for our content, as well as an advanced platform designed to engage the audience.
Response from Phoenix Barringer, Marketing Manager at Bend Research, a division of Capsugel Dosage Form Solutions
2. What are you looking forward to explaining to the audience?
We are currently developing a bioprocess definition platform based on a fundamental understanding of input/output relationships and system dynamics. This platform is enabled by an integrated laboratory setting, which contains automated sampling handling hardware combined with PAT technology and large data set reduction software tools. A case study will be presented that highlights the capabilities of the lab and a bioprocess development methodology that focuses on increasing product quality and streamlining the product development critical path.
Response from Jeff Breit, Director at Bend Research, a division of Capsugel Dosage Form Solutions
3. How did you get into the industry?
Bend Research has a track record of scientific and engineering excellence in the pharmaceutical development space. Our clients requested that we leverage our engineering and biological expertise to better understand and consider optimizing practices in biologics manufacturing. Since venturing into this space approximately 8 years ago, we have advanced certain technologies, often with development partners, in order to streamline and ensure direct application in upstream and downstream manufacturing practices. Recently, we have focused our efforts on integration, data reduction and prediction, as these capabilities and technologies are needed to advance next generation processes in fed batch, perfusion and continuous manufacturing.
Response from Jeff Breit, Director at Bend Research, a division of Capsugel Dosage Form Solutions
4. Why are cell response dynamics important for developing a feed or control strategy in a bioreactor?
We are using cell responses to generate the right kind of data to build a predictive model showing how the inputs, like feeds, affect the outputs, such as titer and product quality. A predictive model of this type can help to develop a feeding strategy through predictive optimization, and by increasing process understanding of how the selected inputs affect the product outputs. A predictive model can also be used in a model predictive controller for active control of product outputs.
Response from Brandon Downey, Technical Group Leader at Bend Research, a division of Capsugel Dosage Form Solutions
5. In regards to PAT integration in your lab, how are your selecting analytical tools and how are you using the data sets that are produced?
Analytical tools measure the product outputs that are important from a quality perspective. Essentially, whatever needs to be controlled should be measured. The most important product quality measurements may vary from product to product, but the underlying methodology is the same.
Response from Brandon Downey, Technical Group Leader at Bend Research, a division of Capsugel Dosage Form Solutions
Join Jeff & Brandon in Bend Research’s webinar ‘Innovative, PAT-Integrated Bioprocess Environment’ on 3 June at 4pm London/11am New York.