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May 13, 2019

Your strategy to manufacture, no longer a one-size-fits-all

By Olivier Loeillot, General Manager, BioProcess - GE Healthcare Life Sciences

Olivier Loeillot is the general manager of GE Healthcare Life Sciences BioProcess division. His goal is to provide flexible manufacturing solutions that enable customers and partners to develop and deliver important new therapies for patients. Learn more from Olivier at the BIO International Convention, June 3 to 6, 2019, in Philadelphia, booth # 3519. If you would like to schedule an in-person meeting at BIO, please submit your request on our event page.

Medicine is no longer one-size-fits-all. Your strategy to manufacture it, shouldn’t be, either.

Healthcare—and accordingly, biopharma--- is changing and improving every day. Biopharmaceutical companies are moving away from the one-size-fits-all blockbuster pharmaceutical model toward increasingly more innovative, targeted biologics that deliver better patient outcomes. In fact, the number of new biologics the U.S. FDA has approved each year has gone from three per year since the 2004-2008 timeframe to more than 20 in 2018 (1). The pharmaceutical industry is also investing heavily in increasingly more precise medicines with major acquisitions in novel gene therapy companies such as Spark Therapeutics (Roche) and AveXis (Novartis). Biologics and cell therapies may not completely replace larger biopharma operations, but with this level of investment, they appear to be here to stay. Of course, that means the tried-and-true model of traditional big batch manufacturing must change as well.

Impact on drug manufacturing

For decades, big batch manufacturing-- a multi-step, lengthy process utilizing large-scale stainless-steel equipment—has been the strategy of choice for biopharma companies. This approach is ideal for producing massive quantities of drugs. However, manufacturing targeted biologics requires flexibility, handling small numbers of high-value batches at an increased frequency. It requires more versatility in process, equipment, raw materials, and even operator expertise. With this added complexity, the industry must find efficiencies and new ways of working to be more flexible and agile.

To get there, our customers in biopharma and biotech organizations will make strategic manufacturing decisions in order to efficiently, quickly, and productively deliver the molecule(s) in their pipeline to the market. Those decisions won’t be one-size fits all: Questions like ‘should we outsource our manufacturing or create in-house capacity? Do we need to build a new facility or outfit an existing one with a new process? Should we use single-use technology? How do we set up and train our operators to be more effective?’ are all critical considerations- and the direction followed impacts the speed, investment, validation effort, and flexibility that an organization will be able to accomplish.

We’re here to help.

The solution isn’t simple

Several bioprocessing advancements form the building blocks for manufacturing biologic medicines. As biopharma pipelines grow, there is increasing demand to produce multiple therapies in parallel. The industry needs to have the right capacity, in the right locations. Increasingly, single‑use technologies are being seen as important because they enable flexible, multi-product, small batch production and minimize cross-contamination between products. Modular construction facilitates the rapid and flexible build-out of manufacturing sites at significantly lower costs than building a permanent batch facility. Closed and/or continuous manufacturing processes coupled with automation have the potential to drive efficiency and reduce risk of product loss. The operator is physically separated from the product in a closed system, which minimizes human contamination. Sophisticated process controls in continuous manufacturing allow the review of all production variables in one system, so any necessary intervention doesn’t disrupt the entire manufacturing process. All of these factors mean more efficient operations and lower product costs.

Beyond bioprocessing

Biologics have time and temperature sensitivities that require a highly controlled and fully traceable supply chain. Time and temperature sensors in manufacturing suites, warehouses, trucks, labs, and pharmacies monitor safety and efficacy of drugs in transit and in storage. Targeted medicines have the added complexity of chain of identity tracking from patient to manufacturer and back to patient to ensure the therapy originated from the person receiving treatment. All of these controls also influence product packaging design and must be tested and validated under real-life conditions to achieve regulatory approval.

The promise of precision medicine depends on industry innovation

I believe it will take coordinated industry cooperation to get to the point where these bioprocessing concepts are more fully integrated and developed into a flexible manufacturing system suited to producing multiple biologics and cellular therapies. Equipment developers, like GE Healthcare Life Sciences, working in close collaboration with biopharma companies, treatment centers, and CDMOs can capitalize on our bioprocessing experience and product offering to create the factory of tomorrow. This will help get these novel therapies to more patients, paving the way to precision medicine and future therapeutics.

Reference
1. www.fda.gov