Biologic manufacturing: Quality and efficacy lead to cost-effectiveness

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/scanrail)
(Image: Getty/scanrail)

Related tags: biomanufacturing, Manufacturing, Cost, Quality assurance, Ge healthcare

Biologics come with a hefty price tag, both to patients and manufacturers, but cost-effectiveness may be obtained through quality assurance.

GE Healthcare Life Sciences have been working with manufacturers to develop solutions to establish more cost-effective biologic drug production. We spoke with Madhu Raghunathan, global product strategy leader at GE Healthcare, about cost-effective drug manufacturing before he hits the stage at Interphex 2019 to carry on the discussion.

He began by explaining that the pharmaceutical industry is capital intensive for all stakeholders and that cost-effective manufacturing is a fundamental challenge for all involved.

Raghunathan told us the company’s clients, manufacturers of biologics, are trying to produce drugs that are efficacious and can be brought to the market quickly in a cost-effective manner while meeting quality standards in a scalable manner.

“All of those things can be challenges, as well as offering opportunities for us as vendors because we are able to fulfill each of those aspects with products and solutions that we offer,”​ Raghunathan explained.

He gave the example of Humira (adalimumab), which brought in $19.9bn (€17.63bn) worth of revenue last year, as a drug with efficacy that is hard to determine.

“You’re talking about a drug that’s pretty expensive to a patient but the efficacy is only 20-25%. So, this is a challenge that everybody recognizes. As a manufacturer of biological drugs, companies are looking at how can drugs actually be more effective.”

Search for efficacy leads to cost-efficiency

Raghunathan told us that this search for efficacy is one of the reasons why personalized therapies, as well as subclasses of monoclonal antibody (mAbs), are starting to hit the market – with innovation for efficacy comes innovation for cost-efficiency.

“When we start to have some of these personalized therapies, it changes the way in which you develop and manufacture these drugs. All of a sudden, you’re not manufacturing drugs at the 100s of kilogram scale, you’re manufacturing these drugs in the kilogram or gram scale and that poses a great challenge,”​ he explained.

“The way these drugs are being manufactured, where they’re being manufactured, they could be manufactured in a hospital instead of in a plant – all of these factors means we have to make sure we have the right products and the right workflow solutions to manufacture these types of therapies at the scale that they are being manufactured.”

To Raghunathan, an important component of cost-efficient manufacturing is the proper size of the facility in which materials are manufactured. “If you underestimate and build a facility that’s smaller than the actual volume of the drug that’s needed, we’ve seen people lose out on revenues of several hundred million, even a billion dollars, because they built a facility that’s too small.”

He continued, “On the other hand, if you build a facility that’s too big you’re going to underutilize the facility and that’s going to drive up costs because the cost of manufacturing a biologic drug is between $50-100 a gram all the way up to $500 a gram if you’re not efficiently utilizing the facility.”

Process and adhering to the highest quality standards is the way in which he believes manufacturers can establish cost-efficiency, in order not to lose money on any batches of biologics that cannot be used if manufactured incorrectly.

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