Product Design & Development

LGO interns interested in making something new can do an internship in product design and development. Projects in this category allow students to combine their engineering and MBA knowledge in a unique way to solve problems related to design, product implementation, and new supply chain systems.

Novel Oral Drug Delivery for Biologics

Kaitlyn Nealon (LGO ’18)

Company: Amgen
Location: Thousand Oaks, CA

Problem: Oral delivery of large-molecule drugs has been an unattainable “holy grail” for the past century. Amgen asked Kaitlyn to consider novel delivery mechanisms that could deliver a clinically relevant drug to a patient’s system, while protecting the proteins in the drug from being disrupted in the harsh enzymatic environment of the gut.

Tactical Next steps for Testing of the Technology A device
Tactical Next steps for Testing of the Technology A device

Approach: Kaitlyn started her project by researching dozens of oral biologics delivery technologies across startup companies and academic research. She assessed each technology’s value proposition as applicable to Amgen’s drug pipeline, conducted a literature review into historical barriers, and reviewed the current technology landscape. Kaitlyn identified two promising technologies that use novel methods to deliver drugs through the intestinal lining into the patient’s system. She prioritized risks to evaluate for each technology, including the size of the final device and payload capacity.

Impact: Kaitlyn modeled in silico the mechanics of one technology and the spread of drug product as a preliminary test. The results of this modeling showed this technology can be optimized mechanically to deliver liquid drug product successfully through the intestinal lining and into the patient’s system. If the new technologies Kaitlyn identified prove successful, the resulting products could be highly disruptive in the industry, allowing Amgen to revolutionize how patients interact with biological medicines.

Predictive Computational Modelling in Biologic Formulation Development

Jayanthi Jayakumar (LGO ’17)

Company: Amgen
Location: Thousand Oaks, CA

Problem: Amgen is a leading biotechnology company that creates protein therapies to treat severe diseases. To transform a disease-modifying protein into a drug that can be administered to patients, scientists need to develop it into a stable formulation. Excipients are inactive ingredients that perform various important functions in biologic formulation, including providing protein stability. However, identification of the correct excipients for optimum formulation development can often be time consuming and expensive. Jayanthi’s project uses advancements in computational biological modelling to evaluate its predictive role in biological formulation development.

Approach: Jayanthi began by identifying databases of compounds that could be tested computationally and experimentally as excipients. Then she worked with her mentors from Amgen and advisors from MIT to develop a high throughput method to computationally model a target protein and hundreds of potential excipients. Based on these results, she tested a sub-segment of these excipients in the wet-lab setting and compared them to the predicted outcomes from the computational model.

Impact: Amgen can use Jayanthi’s work as a starting point to develop predictive computational models that can be used in excipient selection for biological formulation development. This may ultimately save Amgen significant time and money. In addition, these models may help elucidate atomic level interactions between excipients and proteins, advancing the science behind formulation development.

Improving Performance using Glass Cartridge Silionization

Scott McArthur (LGO ’17)

Company: Sanofi
Location: Frankfurt, Germany

Problem: At Sanofi’s Site Frankfurt Insulin (SFI) and Site Frankfurt Devices (SFD), the company produces insulin delivery devices for patients with diabetes. Scott’s internship focused on glass cartridges, the primary packaging for insulin used in pen injection systems. Sanofi and Scott wanted to better understand the process of baked-in siliconization. When used in glass cartridges, the process is helpful for injectable pharmaceutical products. Scott’s project aimed to make the friction and lubrication characteristics of these cartridges more consistent, and therefore better performing for the patient. If these two variables are better controlled, current device will perform better, and other injection devices could result, ultimately improving patient experience.

Scott’s analysis helped Sanofi better understand a new injection manufacturing process.

Approach: Scott studied three specific processes. First, he studied the current state in the filling line characterization. Second, he looked at how friction force correlated to it and developed a recommended silicon profile. Finally, he conducted feasibility tests of atmospheric pressure plasma treatment. The results uncovered differences between different filling lines which led to recommended parameters that define a ‘good’ siliconization profile.

Impact: Scott’s recommendation, which is based off the data presented in the diagram pictured, has the potential to reduce variation in friction force performance by a factor 15. The next year’s LGO intern at Sanofi will use Scott’s results to focus optimize and standardize the siliconization profile across all filling lines in the facility.

Reducing New Product Development Time Using 3D Printing

Michael Sandford (LGO ’17)

Company: Johnson & Johnson
Location: Bridgewater, NJ

Product Design and Development Internship J&J
An example of a 3D printed medical devise at Johnson & Johnson.

Problem: The medical devices industry places great importance on speed to market in new product development. A short time to market means the product will have a longer sale lifetime and greater customer loyalty. Johnson & Johnson (J&J) is exploring additive manufacturing, or 3D printing, as a way to accelerate their product design and development process. Mike’s goals in this project were to reduce new product development cycle time and enable project teams to use 3D printing across J&J.

Approach: Mike developed a collaboration process to connect 3D printing experts in J&J with product development teams. These collaboration sessions (“blitzes”) resulted in many different ways to utilize technologies like metal 3D printing to create injection molds.

Impact: Thanks to Mike’s project, J&J utilized several promising 3D printing techniques to accelerate new product development. When he was able to engage projects early, Mike to accelerate launch substantially. All told, Mike’s recommended technical and business process changes show multi-million dollar potential for J&J.