Amidst a hail of in­vest­ments com­ing from South Ko­re­an con­glom­er­ates in­to biotech, in­clud­ing Lotte and Sam­sung, SK is look­ing to get in on the ac­tion.

SK Pharmte­co, a CD­MO and sub­sidiary of the sec­ond-largest con­glom­er­ate in South Ko­rea, is in­vest­ing $35 mil­lion to ex­pand SK’s phar­ma­ceu­ti­cal man­u­fac­tur­ing plant in the Dublin sub­urb of Swords, Ire­land, in­clud­ing a new build­ing.

Ac­cord­ing to SK, the ex­pan­sion project will pro­vide an in­crease in the site’s man­u­fac­tur­ing ca­pac­i­ty and ca­pa­bil­i­ties, com­ing on­line some­time in 2024.

The first phase of the project will in­clude a new man­u­fac­tur­ing build­ing, which will aim to in­crease re­ac­tor vol­ume ca­pac­i­ty. The new build­ing will al­so con­tain fil­tra­tion and dry­ing equip­ment, as­so­ci­at­ed util­i­ties and the ca­pa­bil­i­ty for ad­di­tion­al man­u­fac­tur­ing lines and tech­nolo­gies in fu­ture phas­es of the project.

The ex­pan­sion will hap­pen over two phas­es, with ad­di­tion­al fund­ing for sub­se­quent phas­es. On com­ple­tion, the ex­pan­sion will re­sult in an over­all 50% in­crease in ca­pac­i­ty at the Swords cam­pus.

“With sub­stan­tial growth in our busi­ness base, this ex­pan­sion sup­ports SK biotek Ire­land’s po­si­tion as a key con­trib­u­tor to SKPT’s EU and world­wide busi­ness,” said Joyce Fitzhar­ris, pres­i­dent of SK biotek Ire­land, in a state­ment.  The new plant will be lo­cat­ed on the foot­print of a de­com­mis­sioned pro­duc­tion build­ing on-site, with­in prox­im­i­ty to SK’s oth­er site fa­cil­i­ties.

This is the sec­ond ma­jor ex­pan­sion project SK has em­barked on. In 2020, the Swords Cam­pus com­plet­ed a $30 mil­lion re­ac­tor ca­pac­i­ty ex­pan­sion.

The cam­pus has been around for 60 years as a small mol­e­cule API man­u­fac­tur­er, pro­duc­ing on­col­o­gy and car­di­ol­o­gy treat­ments.

This comes at a time not on­ly when oth­er com­pa­nies are look­ing to build out or ex­pand on the Emer­ald Isle, but as SK is mak­ing more in­vest­ments in biotech.

Ear­li­er this year, SK said it will in­vest $350 mil­lion in­to the Cen­ter for Break­through Med­i­cines, with plans to add 2,000 em­ploy­ees as part of a re­dux at the CD­MO’s King of Prus­sia, PA, fa­cil­i­ty.

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.”