Summary - AIChE Chicago - October 2026 Meeting

The Chicago Section of the American Institute of Chemical Engineers is delighted to announce that it will be hosting a plant tour of Baxter International's Round Lake Drug Delivery Plant at 2:00 PM followed by a meeting at Slyce Coal Fired Pizza at 4:00 PM on October 22nd.

The meeting will feature speaker Catalina Mogollon who will present on the development and technology transfer of a new, ready-to-use infusion bag formulation used to replace traditional glass bottle packaging.

The tour will start at 2:00pm. Please note that the tour is limited to the first 12 registrants, so be sure to reserve a spot!

**Please arrive on-time to attend the mandatory safety video, site presentation and PPE fitting for tour**

**Please also note that to qualify for PDH credit, you must attend the meeting's technical presentation**

Catalina Mogollon is a Research Scientist at Baxter International with 10 years of experience in pharmaceutical process development, technology transfer, and process validation for parenteral products. She leads global manufacturing and commercialization initiatives, including process scale-up, registration stability studies, regulatory submissions, and cross-site technology transfers.

Since joining Baxter International in 2017, Catalina has successfully led product launches, manufacturing transfers, process optimization projects, and validation programs that have improved product quality, supply reliability, and regulatory compliance. Her expertise includes CMC development, process validation, Lean Six Sigma methodologies, and cross-functional leadership.

Catalina holds B.S. and M.S. degrees in Chemical Engineering from the University of Illinois at Chicago and has received multiple awards recognizing her technical leadership and contributions to pharmaceutical manufacturing excellence.

This presentation describes the development and technology transfer of a ready-to-use (RTU) infusion bag formulation of a fast-acting vasodilator previously marketed in a glass bottle. The project was initiated to leverage newly available non-interacting film materials and establish commercial manufacturing at a receiving Baxter site. The presentation outlines the rationale for the product conversion, the capabilities of the transferring and receiving manufacturing facilities, and the implementation of new equipment, material handling procedures, and waste management controls required for successful transfer.

The manufacturing process is reviewed from raw material weighing and solution preparation through filtration, filling, inspection, overpouching, terminal sterilization, and final product release. Particular emphasis is placed on process controls established for solution mixing, filtration, fill volume accuracy, sterilization, and handling of the active pharmaceutical ingredient.

The process evaluation confirmed that the receiving site manufacturing process is capable of producing the RTU infusion bag product with acceptable quality. Registration stability batches were successfully manufactured across multiple dose strengths, supporting regulatory submission activities. The program establishes a robust foundation for post-approval process qualification, commercial launch, and expansion of the product portfolio from glass bottles to flexible infusion bags.

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AIChE Chicago - October 2026 Meeting

Slyce Coal Fired Pizza

Speakers

Catalina Mogollon

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