As­traZeneca has been grow­ing its pres­ence in Chi­na over the past sev­er­al years, and the phar­ma’s lat­est ven­ture in the coun­try will see it es­tab­lish a man­u­fac­tur­ing process for COPD treat­ments.

Ac­cord­ing to a press re­lease, trans­lat­ed from Chi­nese, As­traZeneca of­fi­cial­ly an­nounced it will ex­pand its in­vest­ment in Chi­na and plans to spend some cash to con­struct a pro­duc­tion and sup­ply base as well, as a re­gion­al head­quar­ters in the port city of Qing­dao, Shan­dong in east­ern Chi­na. Qing­dao will al­so be home to an in­no­va­tion cen­ter fo­cused on rare dis­eases, a life sci­ence in­no­va­tion park and an in­dus­tri­al fund.

The com­pa­ny ad­di­tion­al­ly said that the planned man­u­fac­tur­ing and sup­ply base in Qing­dao will pro­duce the in­gre­di­ents for Breztri, a ther­a­peu­tic that treats COPD. As­traZeneca de­clined to com­ment on the cost, size or time­lines on the man­u­fac­tur­ing space and in­no­va­tion cen­ter.

“As­traZeneca’s in­vest­ment in the Qing­dao pro­duc­tion and sup­ply base aims to bet­ter meet the huge de­mand of pa­tients for Breztri in­hala­tion aerosols. To fur­ther pro­mote the de­vel­op­ment of Qing­dao’s bio­phar­ma­ceu­ti­cal in­dus­try and con­tribute to the Na­tion­al Health Vi­sion 2030, As­traZeneca will con­tin­ue to strength­en its con­fi­dence in in­creas­ing in­vest­ment in Chi­na,” said Wang Lei, the Chi­na pres­i­dent of As­traZeneca, in a state­ment.

Breztri, which gained ap­proval in Chi­na in 2019, had a rocky jour­ney with US reg­u­la­tors. In 2019, the triple-drug com­bi­na­tion treat­ment was orig­i­nal­ly shot down with a CRL, but it fi­nal­ly re­ceived the green light in 2020.

And while As­traZeneca has a sol­id pres­ence in Chi­na with sup­ply bases in Wuxi and Taizhou, Jiang­su, Chi­na, some staffers re­cent­ly found them­selves in trou­ble.

In Jan­u­ary, mul­ti­ple sus­pects were ar­rest­ed in con­nec­tion with an al­leged med­ical in­sur­ance fraud scheme or­ga­nized by As­traZeneca Chi­na em­ploy­ees, the coun­try’s Na­tion­al Health­care Se­cu­ri­ty Ad­min­is­tra­tion (NHSA) said. The ar­rests oc­curred af­ter an in­ves­ti­ga­tion found ev­i­dence that staff mem­bers tam­pered with the ge­net­ic test­ing re­sults of tu­mor pa­tients to de­fraud med­ical in­sur­ance funds.

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.

As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.

ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.

As the manufacturing of cell and gene therapies is ramping up and companies are starting to invest in their manufacturing capabilities, Terumo Blood and Cell Technologies have formed a partnership to stay in the game.

According to the company, it has signed a new collaborative agreement with GenCure, a subsidiary of BioBridge Global, to extend and unify cell and gene therapy manufacturing solutions.

Earlier this year, Novartis touted its radioligand as a major piece to counter competition in the cancer space. However, the physical production of its products has had anything but a smooth ride.

In May, Novartis had to suspend production of Lutathera and Pluvicto, its two primary radiotherapies. According to the company, this was done out of an abundance of caution as a result of potential quality issues identified in its manufacturing. The production suspension impacts the commercial and clinical trial supply of the products.

A manufacturing facility belonging to the Netherlands-based API producer Fagron Group has entered the FDA’s crosshairs after an employee destroyed a cleaning log, among other violations.

One of its plants in Saint Paul, MN received a warning letter on June 14, following an inspection last November that uncovered cross-contamination concerns.

“In your response, you provided a follow-up cleaning validation report in which you only assessed the carryover of niacin swab samples but not progesterone, which was included in your initial cleaning validation,” FDA says in the letter. “The lack of progesterone (b)(4) [commercially confidential information] is concerning considering the failing residue results you provided to investigators would yield unacceptable levels of progesterone cross-contamination.”