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Fierce Pharma Manufacturing·· 4 小时前AI 评分49

Lonza扩大瑞士Visp ADC扩产计划范围,新增中等规模生物偶联能力

Lonza rounds out Swiss ADC expansion's scope with mid-scale capabilities

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Lonza于10月29日公布其瑞士Visp基地抗体偶联药物(ADC)扩产计划的新细节,项目将包含三套多产品生产套件,商业产能预计2028年上线。公司还计划从明年起在现有生物偶联套件中引入500升一次性使用产能,将中等规模生物偶联生产的灵活性与6月公布的大规模扩产相结合。大规模设施目前在建,采用不锈钢和一次性使用生产,规模最高达1200升。

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Image 5: Lonza

Lonza framed the evolution of its expansion plan as wedding the “flexibility of mid-scale bioconjugation manufacturing” with the previous large-scale project unveiled in June. (Lonza)

Several months after telegraphing a major antibody-drug conjugate manufacturing expansion in its native Switzerland, CDMO Lonza is laying out fresh details and growing the project’s scope.

Building upon a June announcement in which Lonza committed to expand its payload-linker manufacturing capacity at its R&D and production hub in Visp, Switzerland, the contract manufacturer said Thursday that the project will now include three multiproduct suites as it predicted that commercial capacity will come online in 2028.

Among the site’s existing bioconjugation suites, meanwhile, the company now plans to introduce 500 liter single-use capacity starting next year, according to an Oct. 29 release.

The CDMO framed the move as wedding the “flexibility of mid-scale bioconjugation manufacturing” with the previous large-scale expansion announcement in June. At the time, Lonza said the project, for which it hasn’t disclosed its investment, would bolster its ability to produce highly potent active pharmaceutical ingredients (HPAPI) and establish new commercial capabilities for the booming antibody-drug conjugate (ADC) field.

The additions to the project should now support customers looking for help with their ADCs and other bioconjugates from clinical development through to commercial supply at the Visp campus, Lonza explained.

“As more ADCs and other bioconjugates advance towards commercialization, customers need confidence that manufacturing capacity can grow with their programs,” Christian Seufert, Lonza’s head of advanced synthesis, said in a statement. “Lonza’s investments in Visp reinforce our ambition to be the leading CDMO partner for integrated bioconjugation development and manufacturing solutions.”

The plans to equip Lonza’ mid-scale bioconjugation suites with single-use capacity should help the company chip in on multiple products and programs, with additional plans to bring on chromatography firepower and “parallel manufacturing capacity,” which Lonza said will support faster campaign changeovers, flexible planning and a broad spectrum of bioconjugate projects from its clients.

As for the large-scale facility, now under construction, Lonza said the site will feature stainless-steel and single-use manufacturing at scales up to 1,200 liters.

Around the time Lonza unveiled designs on the Visp upgrade, the company also noted that it had grown its pact with a “leading” U.S. pharma company, tacking on commercial production for a pair of unnamed biologics programs. Lonza noted that it provides services for the partnership across sites in both Europe and the U.S.

Stateside, the contract manufacturer last month said it would build out a new facility in Bend, Oregon, with the project slated for completion around 2029.

Lonza has pegged the upcoming plant in the Pacific Northwest as a commercial spray drying facility. As with the Visp project, Lonza did not disclose an investment figure for the Bend plant.

来源:Fierce Pharma Manufacturing · fiercepharma.com