In the healthcare industry, Tridiagonal services both pharmaceutical companies and biomedical device companies.
Services to Pharmaceutical Industry:
Current Good Manufacturing Practices (cGMP) in the Pharmaceutical Industry requires a Quality by Design (QbD) approach to drug discovery, process development and manufacturing. Process analytical technology (PAT) initiatives have been implemented as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters (CPP) which affect Critical Quality Attributes.
A QbD initiative will need to demonstrate the following:
- The product is designed to meet intended use
- The process is designed to consistently meet product critical quality attributes
- The impact of starting materials and process parameters on product quality is understood
- Critical sources of process variability (raw materials, process) are identified and controlled
- The process is continually monitored and updated to allow for consistent quality over time
There is significant potential to harness the power of modeling in a QbD initiative. Through extensive R&D and industrial application predictive modeling approaches have been developed at Tridiagonal to assist customers with scale up and optimization. We assist pharmaceutical companies in API manufacturing (Chemical R&D) initiatives as well as the powder processing and tablet coating applications. The team extensively uses CFD and DEM methods to develop 3-D models of various unit operations. In Biologics manufacturing, the team has worked on scale up of bioreactors and optimization of these reactors. Shear, oxygen transfer rates and pH are critical parameters of interest.
The team has expertise in the following areas:
- Mixing
- Powder processing and particulate flow
- Coating
- Reactor design and scale up
- Design of Lab and Pilot Scale Equipment
- Develop software tools for mixing applications
- Convert batch to continuous processes
Services to Biomedical Industry:
Rapid advancements in medical imaging and modeling technologies enable biomedical companies to significantly accelerate product development. The industry has much to gain by utilizing modeling tools early in the process. Modeling platforms allow design engineers to rapidly evaluate their design space during the ideation phase. Promising designs can then be worked during detailed design.
Tridiagonal has been involved in servicing the industry in a number of applications involving design of drug delivery systems. Drug delivery system designs typically involve modeling of drug delivery from the device into a tissue of interest and the diffusion of the drug in the tissue. Diffusion is anisotropic and there are partitioning effects to also consider. This sets up unique drug concentration profile that is a function of the device design, the tissue properties and the various transport parameters. These are hard to predict with simple analytical models. CFD methods have made tremendous progress in modeling these systems.
Hemolysis is a key concern when designing devices that process blood. The magnitude of the shear and the duration of exposure of the blood cells to high shear are key contributing factors that determine the possibility for hemolysis. Tridiagonal has unique modeling frameworks to provide statistics on the shear rate exposures of blood cells. This can be used to calculate a hemolysis index and determine the possibility of hemolysis.
The team has expertise in following areas:
- Drug transport modeling in tissues
- Blood flow modeling in devices including Hemolysis Index Estimation
- Drug Release rates from drug matrix systems
- Performance prediction and Noise reduction of fans in sleep apnea devices
- Patient specific modeling – aerosol transport in lungs and hemodynamic studies in aneurysm
- Extrusion Die Designs for catheters
- Dry powder inhaler designs
