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The hottest new area of medicine today is a cutting-edge technology that leverages the body’s own cells to treat disease.
Companies have been pouring in and investing billions. But they’re encountering one big challenge: actually making the treatments.
New gene and cell therapies are encountering years-long backlogs, and delays keep potentially lifesaving medicines away from patients.

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For the biotech company Meira Gtx, a 29,000-square-foot factory in central London is the solution to a problem that has bedeviled its entire industry.

The $660 million startup develops cutting-edge gene therapies, which tinker with the body’s DNA in hopes of treating serious illnesses. Meira focuses on a number of diseases of the eye, salivary gland and brain.

The company had only just started in 2015 when a huge opportunity opened up, to lease a drug manufacturing facility from a leading UK eye hospital. Meira jumped at it, quickly hiring pharma veterans to build out its capabilities and take over manufacturing, snapping up its new head of quality from the Swiss drug giant Novartis.

Gene therapy is the hottest area in medicine, offering up the potential to treat or even cure devastating rare and not-so-rare diseases. Gene therapy and a sister field, cell therapy, attracted more than $13 billion in global financing last year, by an industry group’s count. Some products have already been approved in the US, and many more are in the works, with more than 1,000 research trials ongoing.

But first, companies have to make the medicines. In a field so new, trendy, and intensely complicated, manufacturing has become a crucial, costly and time-consuming challenge, with a surge of new interest forcing biopharmaceutical companies to either build their own multimillion-dollar facilities or else wait on lines for years for others to manufacture them.

Meira’s enviable capability has sparked requests from other companies to make their products. And it could well explain an up to $440 million partnership the biotech inked with Johnson & Johnson’s Janssen earlier this year, focused on both research and improving manufacturing.

“Manufacturing is critical to us,” Alexandria Forbes, Meira Gtx’s president and CEO, said in an interview with Business Insider. “It’s an industry-wide issue.”

The biotech deliberately focused on disease areas where it wouldn’t need to make huge amounts of the product, Forbes said. But other companies are facing the challenge …read more

Source:: Business Insider


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