Lifecore Injectables CDMO is a Minnesota-based CDMO specialized in the development, fill/finish and commercialization of sterile injectable drugs, biologics, medical devices and combination products. The company supports global customers of all sizes in pre-clinical, clinical, and commercial stages with expertise in straightforward to highly complex formulations. Backed by over four decades of global regulatory success, Lifecore strives to meet challenges head-on and develop robust, efficient processes that scale.

In this conversation with Contract Pharma, Nathan Meehan, Process Engineer, Lifecore Injectables CDMO, highlights the organization’s sterilization strategies in injectable manufacturing. He explores how the company overcomes the challenges that make sterilization difficult, changing regulatory expectations, how sterilization affects formulation and process design, future trends and more.

Contract Pharma: Why is sterilization such a challenging aspect of injectable drug product manufacturing?

Nathan Meehan: Sterilization is inherently challenging because it is, by nature, destructive. It is designed to remove and/or destroy microorganisms, and that same mechanism can damage drug products. Many injectable formulations, particularly…