How Lifecore Biomedical Tackles Complex Manufacturing Challenges Through Technical Grit

“Other CDMOs couldn’t handle these products, but we figured it out through technical grit and deep expertise,” explains Jackie Klecker, Executive Vice President of Quality and Development Services at Lifecore Biomedical.

In a CDMO Live Preview episode of the PharmaSource podcast, Jackie and Ryan shared insights into how Lifecore Biomedical has built its reputation as a contract manufacturer capable of handling the most challenging manufacturing projects, particularly as it celebrates its 60th anniversary in 2025.

Jackie Klecker brings 30 years of medical device and pharmaceutical manufacturing expertise to Lifecore Biomedical, where she’s spent 15 years evolving from technical operations to her current position leading quality and development services. She is joined by Ryan Swanson, Director of Process Development, who brings 11 years of industry experience, including significant CMC expertise from his time at Bristol Myers Squibb.

Deep Technical Expertise Built on Complex Foundations

Lifecore’s journey began with sodium hyaluronate raw material production, which proved to be excellent training ground for handling complex manufacturing processes. “Working with sodium hyaluronate solutions has really helped us with our technical expertise,” explains Jackie. “When you deal with sodium hyaluronate solutions, it’s as viscous as maple syrup, over 100,000 centipoise.”

This foundation has evolved into broader capabilities. “While historically that meant handling very viscous products, we’ve evolved to include more sensitive molecules that may be sensitive to light or oxygen,” Ryan explains. “We’ve been able to put manufacturing controls in place to accommodate for that.”

A Culture of Technical Problem-Solving

“We really have this culture of grit,” Jackie emphasises. “We’ve had clients come to us because their CDMO could not do a filling. We were able to figure it out through our very deep, knowledgeable group in process development and our experienced filling team who has been able to fill solutions without bubbles and handle extremely viscous solutions where we had to redesign parts of the filling process.”

Phase-Appropriate Manufacturing Solutions

Lifecore takes a practical approach to early-stage manufacturing. “We created a series of policies and procedures that allow us to create a phase-appropriate GMP manufacturing environment in our pilot facility,” Ryan explains. “This creates more flexibility for our clients and their timelines, while also reducing costs compared to using our commercial clean room space.”

The approach maintains rigorous standards whilst being pragmatic. “We still maintain critical GMP requirements like raw material traceability, line clearance, gowning, environmental monitoring and material transfer,” Ryan adds. “Everything follows a risk-based approach that’s continuously evaluated.”

Comprehensive Regulatory Expertise

With over 40 years of regulatory experience, Lifecore maintains compliance across multiple frameworks, including FDA, EU, Brazil, Canada, and Japan. “Everything we do here is risk-based – every change goes through a risk-based analysis,” Jackie explains. “We definitely want to ensure that the data package we give our customers really can help support their regulatory approvals.”

Meet the Lifecore Biomedical team at CDMO Live 2025. Book your ticket here