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Companies highlight new capabilities at DCAT Week ’18

There was a consistent theme at the company announcements section at the start of DCAT Week in New York on 19 March. CDMOs were keen to share news of investment, acquisition and integration at multiple sites.

Vivek Sharma

India’s Piramal Pharma Solutions is a prime example, investing in capabilities at sites on three continents. CEO Vivek Sharma said that all this was being done in response to increasing customer demand and the continuing growth of the outsourcing trend. “We are getting a lot more traction with existing customers,” he said.

Piramal is spending to increase drug substance capacity at the former Ash Stevens in Riverview, Michigan, Morpeth in the UK – with a new NCE launch facility – and two Indian sites, adding, among other things, niche capabilities in high potency APIs. On drug product, it is spending $30 million at Lexington, Kentucky, where it is adding two lyophilisation lines and one injectable line, and at its Indian sites.

SK Biotek, a subsidiary of the third largest corporation in South Korea, has recently acquired a facility in Swords, Ireland, from BristolMyers Squibb (BMS). This is part of ambitious growth plans in the small molecule space that will complement organic growth at its domestic facilities, said Dr Nitin Parekh, Executive Director of Strategy & Business.

Nitin Parekh

The site has 82 m3 of capacity. It was BMS’s largest small molecule facility, was the birthplace of some key BMS products and, more importantly, SK had already worked with it. “We knew the site, we knew the people, we knew the capabilities,” Parekh said.

The company plans to invest tens of millions of dollars to add capabilities and add to the 350-strong workforce. By 2020, it will revamp Building P3, bringing capacity to 95m3 to service existing clients and make BMS legacy products. There is space to rebuild on another part of the site post-2020, if demand warrants it.

Jean Bléhaut, the new president of Novasep’s Manufacturing Solutions business unit, highlighted an ongoing $65 million investment in biologics across the world. This, he said, is being driven by the “very dynamic expansion” of this market, particularly viral vectors.

Jean Bléhaut

The company is spending $33 million to expand its SenRise brand of viral vectors at Seneffe, Belgium, with two new GMP lines of single-use bioreactors nearing completion. Due for commissioning in Q1 2019, this will make both adherent and suspension cells.

At the same site, Novasep is spending $12 million on monoclonal antibodies (mAbs) and small series viral vectors with a commercial fill-finish facility. Finally, it is investing $20 million at Pompey, France, on a clinical-scale cGMP mAb facility, following on from an antibody-drug conjugate facility there that opened in 2017. This will be commissioned in Q3 and will feature perfusion and a proprietary chromatography technology.

“ADCs are key in our strategy. We already have payload and conjugation capabilities and this will enable us to offer a full service to our customers,” Bléhaut said.

Meanwhile, CordenPharma has acquired a former Pfizer high potency API (HPAPI) site at Boulder, Colorado, near its existing HPAPI facility. The facility, said Jason Bertola, Director of the Global Highly Potent & Oncology Platform, dates back to 1991 and has a long track record of developing and manufacturing HPAPIs down to OELs of 10 ng/m3.

The site has five processing bays of 30-3,000 litres capacity and specific expertise in chromatography. Acquiring it means that CordenPharma now has 40% of its high potency capacity free to offer to clients, where before it was 85% full.

However, said Bertola, “the long-term importance isn’t just an increase in capacity – it is also about integration with our supply chain beyond APIs. We can now offer finished, packaged, labelled products in a shorter time. It also fits in with our goal of boosting our oncology and HPAPI business.”

Finally, Catalent is now in the process of integrating Cook Pharmica, which it acquired in October 2017. Cook’s gigantic site at Bloomington, Indiana, brings a spectrum of fill-finish capabilities, according to Aileen Ruff, VP of Strategy & Marketing at the newly created Biologics & Specialty Drugs Delivery business unit.

This division was created as a result of the buy, also reflecting the growing importance of biologics to Catalent. These are expected to rise from 33% of its pharma business in 2016 to 40% by 2021. Bloomington can produce drug substance at up to 2,500 litres scale, as well as drug product and secondary packaging.

Catalent has also complete the installation of two single-use bioreactors at its site in Madison, Wisconsin, to address the increasingly important <5,000 litres market, plus a flexible filing line at Bloomington.

 



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