Finite Element Analysis of Aggregation Rate Generator: ARGEN FEA Story

BlogFEAFinite Element Analysis of Aggregation Rate Generator: ARGEN FEA Story

ARGEN is a Aggregation Rate Generator created to assess pharmaceutical stability of therapeutic proteins and general stability of natural polymer products

In March 2012, Advanced Polymer Monitoring Technologies, Inc. (APMT) was founded by Professor Wayne F. Reed, Bill Bottoms, Michael F. Drenski and Alex W. Reed to commercialize Professor Reed’s patents, licensed through Tulane University.

Professor Wayne F. Reed began his research in the polymer field in 1985. Years of fundamental and applied research projects through collaborations with hundreds of researchers and millions of dollars in funding have resulted in the development of several novel polymer monitoring and characterization techniques and technologies.

APMT’s mission is to play an enabling role in the polymeric materials and biopharmaceuticals manufacturing industries of the 21st century. They achieve this by delivering innovative products that are vital to the research, development, and production of these materials.

ARGEN: Aggregation Rate Generator

The company’s product, ARGEN, is an aggregation rate generator created to assess the pharmaceutical stability of therapeutic proteins and general stability of natural polymer products. Stability is a major concern for therapeutic protein development. As biopharmaceutical therapeutics are exposed to stressors, they generally tend to undergo unfolding or denaturing events that can potentially lead to aggregation or overall phase instability. In these cases, the therapeutics may lose efficacy or, in a worst-case scenario, become antigenic or harmful to the patient.

The ARGEN system utilizes 16 independent measurement channels to continuously monitor the intensity of light scattering. This measurement is acutely sensitive to extremely small changes in molecular size, for instance when a sample aggregates. To understand the nature of this aggregation phenomena in relation to common processing stressors, the ARGEN incorporates precise, independent control of both temperature and stirring for each channel. Therefore, by continuously monitoring the sample throughout an entire experiment process, the early detection of aggregation, degradation and particle formulation can be directly correlated to stressor interaction and overall sample formulation stability.

Finite Element Analysis

The engineering team decided to use finite element analysis to analyze the ARGEN product line. As there are 16 optical assemblies within a system, its rigidity was a key consideration in addition to its weight because it is a benchtop instrument. Consequently, reaching an optimal balance between weight and rigidity was the main goal of our customer.

This is where SimScale came into play. The team mainly performed FEA simulations to test different framing configurations with different materials. “First we tried different parameters in simulation setups until we found a configuration we were happy with that lead to reasonable results. From there we could set up many parallel experiments to test the effects we were interested in,” said AMPT’s engineers.

The Simulation Results with SimScale

The choice was a solid mechanics simulation, static analysis. The simulation involved contacts, different materials for each body, a fixed constraint at the base of the frame, and pressure load on the mounting board.

It was necessary to test the interaction between the framing and the board that the optical components are mounted on. As in any complex engineering project, challenges were encountered, but they were overcome with the SimScale documentation. As our customer mentioned, what significantly helped was the fact that the simulations ran very quickly and the correct setup was identified much easier than with traditional simulation software. This is actually one of the greatest advantages of cloud-based simulation software. Cloud-based CAE software allows engineers to simulate several combinations and designs at the same time, which means there is no dead time when you are unable to use your computer while waiting for the results.

“Overall the simulations performed excellently. For the project, we ran 25 simulations on 4-core machines. The average run time was 10 minutes,” the team said.

After the initial setup was complete, it was very easy to produce the deformation information that was of interest, and the design process was subsequently split into two parts. Within the first iteration, the engineers switched the framing from a thick gauge aluminum to a thinner gauge stainless steel, whereas in the second iteration, they added a channel down the center of the frame to significantly increase the stiffness without adding much weight.

Conclusion

APMT is planning to continue improving the ARGEN system using SimScale, with a particular focus on further reducing the weight of the system without compromising its performance and better understanding the airflow and heat transfer within.

“We wanted to incorporate computer-aided engineering (CAE) to better understand our design choices without having to execute many expensive prototype runs. Without the use of SimScale, we would have had to allocate more money to test our design choices. By applying numerical simulations, we managed to establish an efficient and cost-effective way to gather data used in design choices,” the company stated.

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