When you’re aim­ing to be the “Fox­conn” or “Ama­zon Web Ser­vices” of biotech man­u­fac­tur­ing, it’s all about do­ing things dif­fer­ent­ly.

Some of those traits are on dis­play in Re­silience’s lat­est deal, a strate­gic col­lab­o­ra­tion to make Be Bio’s B cell ther­a­pies — or at least the ini­tial rare dis­ease pro­grams.

The pact marks the lat­est deal for a fast mov­ing bio­man­u­fac­tur­ing start­up, which has re­la­tion­ships in place with Take­da, Mod­er­na, blue­bird and Har­vard.

First off, there’s no up­front pay­ment. Re­silience is shoul­der­ing the man­u­fac­tur­ing costs in ex­change for the rights to “down­stream eco­nom­ics,” in­clud­ing what Be Bio CEO Joanne Smith-Far­rell calls “mod­est” mile­stones and roy­al­ties on any com­mer­cial prod­ucts. Giv­en Be Bio is still pre­clin­i­cal, that’d be years down the road, if ever.

The biotech will al­so en­joy a ded­i­cat­ed team over at Re­silience to work on­ly on its projects.

“It’s just a com­plete­ly dif­fer­ent thing than I’ve ever ex­pe­ri­enced with oth­er CD­MOs,” said Smith-Far­rell, a for­mer on­col­o­gy ex­ec at blue­bird bio.

Re­silience is the brain­child of Bob Nelsen, the co-founder and man­ag­ing di­rec­tor of ARCH, which al­so led Be Bio’s re­cent $130 mil­lion round. Lever­ag­ing the unique at­trib­ut­es of B cells, the promise (in rare dis­eases) is to en­gi­neer a durable treat­ment op­tion that com­bines the ben­e­fits of en­zyme re­place­ment ther­a­pies and gene ther­a­pies.

Be Bio is keep­ing the process man­u­fac­tur­ing and non-GMP man­u­fac­tur­ing in-house, while Re­silience picks up the tab on GMP man­u­fac­tur­ing.

“We haven’t got it yet on time­lines to the clin­ic,” she said, “but what I would say is it’s fair to as­sume that we’re putting this deal in place now for a rea­son.”

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.”