By allowing ads to appear on this site, you support the local businesses who, in turn, support great journalism.
Clemons: I don't quite understand Shire, but I know this is good news
FDA approval at local plant means good things ahead for leading industry
Shire Corridor
People and products navigate the central spine corridor - known as the "Spine" - at the Shire PLC manufacturing facility in Social Circle, Ga., in a 2016 handout photo provided by the company. The Spine is the main hallway connecting production buildings, laboratories, the warehouse and utility spaces. - photo by Jim Roof Creative

OK, y’all gather ’round. We’re all friends here in the truth tree, so I can be honest.

The story elsewhere in the paper I wrote about Shire earning FDA approval for its Social Circle plant is not the first time I’ve written about the company. And every time I’ve done so, I’ve done it with no clue just exactly what they do out there at Stanton Springs.

It’s a biopharmaceutical plant with about 900 employees, and the company announced Thursday it had earned Food and Drug Administration approval of its first submission from the plant announced in 2012, when Baxter planned to be the first occupant of Stanton Springs.

Baxter spun off its biopharmaceutical business to Baxalta, which Shire acquired in 2016. All that came before the government ever approved the production of immune globulin infusion.

Matt Walker, the head of technical operations for Shire, sounded like a pretty happy guy when we talked on the phone Friday morning.

It took six years from the time Gov. Nathan Deal announced Baxter was coming to the FDA giving its stamp of approval, but Walker said it was all part of a “structured” process.

“All companies that seek FDA approval go through the same process,” he said.

The news came right on schedule, and will lead to a second submission to the FDA later this year, for development of albumin therapy.

But what, pray tell, is all this? I asked Walker to explain to readers — and really, to me — like we’re all 5.

He told me Shire is the leader in its field.

“We have just over $15 billion in revenue last year, so we are a biotech company,” he said. “We have obviously an array of different products. Covington is part of our plasma network. We’re extracting proteins from the plasma we collect from donors throughout the U.S.”

They do that at collection centers in Douglasville, McDonough, Snellville and Warner Robins, and about 100 other locations around the country, in case you’re interested in rolling up your sleeve.

“We collect that through a process called fractionation. We extract the proteins from the plasma. Two proteins that are of interest to us in this facility are IgG (immunoglobulin G) and albumin.”

Shire employees draw the proteins from the plasma, then purify them.

With immune globulin infusion, product is shipped from Stanton Springs to customers around the U.S. The albumin treatment, once approved, will be shipped to a sister facility in Illinois for filling. Walker said that’s because a different technology is used.

Walker is based in Lexington, Massachusetts, and goes to Shire sites around the world. He’s been to the local facility several times and likes what he sees here.

“I think it’s great,” he told me. “I think it’s great for the community. It’s obviously a huge investment. I’ve been involved in a couple of very large investments, and this one’s the largest. It’s going to be tremendous — it already is — and we look forward to working with the local community for many decades to come.”

That future also includes what Walker called “integration planning time” with Takeda Pharmaceutical Co. Ltd., which has made a $62 billion offer for Shire.

“The two companies will begin planning for the future,” Walker said.

I’m still not sure I totally understand, but I do get that the future Walker spoke of is much brighter as of Thursday with the news from the FDA.

David Clemons is the editor and publisher of The Covington News. His email address is Twitter: @scoopclemons.