3:01 PM
Oct 04, 2018
 |  BC Innovations  |  Tools & Techniques

Lilly: academic about manufacturing

Why Lilly is turning to academia to help remake its manufacturing processes

As Eli Lilly and Co. moves toward continuous manufacturing, the pharma is deepening ties with two academic centers to meet an array of engineering challenges. Through partnerships with Carnegie Mellon University, and the U.K.’s Imperial College and University College London, Lilly hopes to bring computer modeling to improve both operations and decision-making.

Continuous manufacturing offers the promise of greater efficiency and lower cost than traditional batch manufacturing, but on the whole pharmas have been slow to embrace the technology.

In particular, the transition requires a shift in approach toward quality by design, a strategy that rests on experimentation and requires different tools.

Whereas standard manufacturing processes involve empirical analyses of individual batches, continuous manufacturing offers an opportunity to design manufacturability into a drug from the start.

Increasing adoption of continuous manufacturing is a priority for regulators. In February, FDA Commissioner Scott Gottlieb outlined the agency’s intent to dedicate a portion of the FY19 $400 million budget increase to develop regulatory standards needed to advance continuous manufacturing of small molecule and biologic drugs.

Last year, FDA and EMA issued a report that evaluated regulatory submissions containing quality-by-design elements, and said the two agencies are exploring joint activities “with specific focus on continuous manufacturing, additional emerging technologies, and expedited/accelerated assessments.”

Lilly has been openly courting the approach. In 2017, it published a paper in Science describing the first cGMP process using continuous manufacturing for an API (see “Lilly Goes with the Flow.”)

“The key is how do we design and scale processes faster?”

Salvador Garcia-Munoz, Eli Lilly

Now, it’s bolstering investments in its university partnerships with a commitment of about $13 million.

On Sept. 6, Lilly extended...

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