Lifecore Biomedical is a full-service contract development and manufacturing organization (CDMO) that partners with pharmaceutical and biotech companies to develop and deliver vital and complex injectable therapies—from formulation to commercialization.

The CDMO’s capabilities for sterile injectable development include formulation, sterilization and process development, as well as analytical, stability, engineering and validation services. On the manufacturing side, Lifecore offers sterilization, aseptic filling, packaging, analytical and stability services.

Lifecore operates two state-of-the-art facilities in Chaska, MN—one covers 143,000 square feet and the other 78,000 square feet. Both are ISO 13485 and GMP certified, international symbols of quality system assurance and compliance.

Contract Pharma recently talked with Lifecore’s president, Jim Hall, about the business as well as sterile injectable market trends. He has been in the leadership role at Lifecore since June 2017. Before that he served as the company’s vice president and general manager since July 2013, as well as other prior leadership roles. In total he brings over 30 years of pharmaceutical and combination product manufacturing and development experience.

Contract Pharma: How has Lifecore Biomedical’s business evolved in recent years?

Jim Hall: Lifecore has leveraged a 35-plus year heritage as a top-tier supplier of injectable grade hyaluronic acid and pivoted to providing specialist full-service contract development and manufacturing capabilities for complex injectable drug formulations.

Our continued investment centers on expanding our vial and prefilled syringe capacity for injectable products, and in strengthening our technical capabilities and systems to support customers from preclinical through commercialization of their products. 

We have also built a world-class quality system that supports all aspects of our industry, including active pharmaceutical ingredients (APIs), excipients, biologic products, medical devices and combination products.

CP: What are some business highlights from this past year?

Hall: Lifecore has doubled its business twice over the last decade and that growth trajectory continued in 2021, and into 2022, recently surpassing $100 million in revenues.
In terms of service delivery, our team has:

• Supported 2 new product approvals—we’re now manufacturing 26 commercial products;
• Grown the clients we support with development services—our pipeline includes 23 projects in various preclinical and clinical phases; and
• Facilitated several successful regulatory and client audits.

We have also opened a warehouse and achieved FDA registration for the site, added new capacity with the investment in two state-of-the-art fillers and expanded our analytical capabilities with the renovation of existing lab space.

CP: How have you had to change to adapt to the COVID-19 pandemic?

Hall: Our supply chain teams have done an amazing job pivoting our strategy by identifying multiple sources, qualifying new materials and securing critical inventories well in advance of production requirements.

We modified our work schedules to encourage social distancing, keep our employees safe and minimize potential virus transmission. The implementation of split and multiple shifts has actually resulted in increased manufacturing throughput and efficiencies.

Introducing virtual work environments for appropriate employees has similarly led to increased efficiency and has allowed us to recruit talent that we may not have had access to previously.

CP: How do you see the injectable drug delivery space evolving over the next few years?

Hall: The overall CDMO market is very strong and growing, led by robust drug development growth and a high propensity to outsource manufacturing. Injectable products are the fastest-growing portion of the overall CDMO market and are anticipated to provide a CAGR of 10.5% through 2023, with prefilled syringe demand outpacing the overall injectable products market providing an anticipated CAGR of 13% through 2023.

Based on these favorable market tailwinds, we see strong performance in the drug development space and for the injectable CDMO service sector.   

CP: What are some important trends and challenges on the clinical development side of your business?

Hall: Drug developers want strong and proven quality systems, speed and reliable execution with technical expertise to support all phases of development, and the capacity to support commercial success at launch and with lifecycle management.

These are the industry’s perennial challenges and Lifecore’s culture is built around providing these critical service components. We’ve continued to invest in our people, systems and infrastructure to ensure we deliver for our partners.

CP: How about on the manufacturing front?

Hall: Novel drug delivery technologies are helping to drive this growth and are vital in bringing new drugs to market and in enabling existing drugs to be delivered in a more targeted and safer manner.

Biologics, MABs, vaccines and drugs targeting chronic diseases are the more prominent candidates driving new investments and development programs. This is creating demand for additional capacity and technical expertise, and we are keenly focused on meeting these industry needs.

CP: How can injectable drug development and manufacturing projects benefit from Lifecore’s expertise?

Hall: Injectable drug development typically requires specialized equipment and unique technical expertise and capabilities. Lifecore has spent more than 35 years working with complex drug formulations centered on hyaluronic acid. Over that time we have developed a unique skill set and knowhow that transitions perfectly when dealing with other complex high-value molecules.

In addition, our team has subject matter expertise in process development, engineering, design assurance, analytical development and manufacturing to assist in bringing novel drugs to market—we can manage the entire development process, supply chain and lifecycle management.

CP: What are your goals for Lifecore in the near term?

Hall: We want to continue to be the CDMO partner of choice for our many blue-chip customers as we continue to expand our capabilities, operating capacities and development pipeline while continuing to support our partners in the advancement of their products.

Several of the products in our current pipeline will hopefully receive regulatory approval in the next 12 to 24 months.

We will also begin the installation and validation of two new state-of-the-art fillers, and continue expanding our development and analytical capabilities with the enhancement and expansion of available lab space.

CP: What are your customers concerns when partnering on projects?

Hall: Customers are looking for the highest quality development with fast and reliable execution, the technical expertise and capabilities to advance development, and the needed capacity to support them in commercial execution if they are successful. Lifecore’s culture is built around providing these critical service components and we’ve continued to invest in our people, systems and infrastructure to ensure we deliver for our partners.