$10 Billion And 1 Million Liters: Here Comes The Biomanufacturing Capacity!

By Louis Garguilo, Chief Editor, Outsourced Pharma

I’ve been a biomanufacturing-capacity-crunch skeptic for years (e.g., from 2018: Time To Silence Capacity Alarms For Bioprocessing?).

Remember when that monumental lack of capacity – internal and external at CDMOs – was going to feel like a massive concrete slab blocking the road to a biopharmaceutical revolution?

It didn’t happen.

Instead of one giant roadblock, though, what has happened is more akin to a multitude of bricks placed in the individual paths of advancing drug development programs.

We know about these capacity crunches from exasperated executives at emerging biopharma of all kinds: outsourced development-scale and fit-for-purpose manufacturing options are in lethally short supply.

Instead of lugubrious 2,000-liter bioreactors, an army of advanced-technology companies are looking to CDMOs for smaller and more nimble capacity to get them up and running – at reasonable start-times and adequate pricing models.

This was exacerbated by the black swan of COVID, which sent waves through the entire outsourcing ecosystem.

Vaccine production in an instance sucked up large-scale capacities. Now there were risks for larger drug owners, right along with the emerging small-scale crunch. However, COVID seems to have actually disproportionally affected small-scale capacity.

So I may have been right to begin with – no widespread, years-long, large-scale crunch. But wrong because small-scale crunches are placing landmines across the emerging biopharma field.

Now help is on the way. Here comes the capacity – hopefully in all its forms and glory.

CDMOs Get Going

Over the past 18 months or so, there have been dozens upon dozens of CDMO announcements for biomanufacturing – and specifically cell-and-gene – capacity additions. DCAT’s Editorial Director Patricia Van Arnum put together a list of over 27 such recent announcements.

I did some back-of-the-envelope number crunching from her (international) list of CDMOs. They’ve announced investments of some $100 billion in new facilities/equipment, topping one million liters in additional capacity, and hundreds of millions of additional (or upgraded) square feet in development and manufacturing footprints.

(These numbers don’t take into account the billions of dollars spent cumulatively in recent M&A, most often of CDMOs by CDMOs.)

Shouldn’t these announcements – and I just saw more today – point to relief on the way for emerging biopharma organizations?

As discussed above, that still depends. It depends on whether this upcoming capacity equally serves bigger pharma requirements as well as the specific needs of emerging biopharma organizations.

Also consider: While the pace of this new capacity buildout is breathtaking – some announcements of even massive expansions indicate facilities will be customer-ready (at least in part) in as little as 12 months – a lot of the new capacity is still months to a year further out from that.

More critically, the emphasis in most all these announcements is on large reactors and increased  large-scale-manufacturing – not inviting to the emerging biopharma market.

We must be fair regarding this point, though. Capacity expansion announcements are precisely that: promotions of the sheer power of more. And typical statements prove that:

“… 256,000 liters in [new] total biomanufacturing capacity”

“… doubling cell-culture production for recombinant vaccines” and “increasing gene-therapy production 10-fold, tripling cell-culture capacity, and doubling microbial fermentation capacity at an existing facility.”

So for whom do these bells toll?

I’d suggest if indeed some are tolling to attract emerging-biopharma clients, CDMOs should also clarify that in their announcements. In fact, a number of them attempt this.

For example, Thermo Fisher (along with other  major capacity expansions), adds this down-sized pronouncement– at least for a local community of potential clients (italics for all examples mine):

“Thermo Fisher Scientific and the University of California, San Francisco (UCSF) formed a strategic alliance to accelerate the development and manufacturing of cell-based therapies by opening a cell-therapy manufacturing and collaboration center. Under the agreement, Thermo Fisher will build and operate a 44,000-square-foot cell-therapy development, manufacturing, and collaboration center in leased space on UCSF's Mission Bay campus … The site will offer clinical and commercial cGMP cell-therapy manufacturing services, along with associated technology development support, to UCSF and other partners. The center is expected to open in 2022.”

AGC Biologics seems to suggest smaller-company targeting, announcing it broke ground on a new biologics manufacturing facility in Copenhagen to more than double the company’s single-use bioreactor mammalian cell-culture capacity at the site … In addition, AGC Biologics expanded its pDNA Center of Excellence in Heidelberg, Germany for process development and manufacturing of plasmid DNA (pDNA). The company announced earlier this year  plans to expand its Cell and Gene Therapy Center of Excellence in Milan, Italy, to increase capacities and implement viral- vector-suspension capabilities.

Genezen Laboratories, an Indianapolis, Indiana-based cell- and gene-therapy CDMO of early-phase process development, viral vector production, and analytical testing services, is planning a 75,000-plus-square foot cGMP-compliant lentiviral vector production facility. The first phase will see the construction of a 25,000-square-feet site that will include a process development lab expansion, scheduled for completion in the autumn 2021.

One final example is Lonza, (also among other, larger scale announcements) is expanding its microbial manufacturing facility in Visp, Switzerland, providing mid-scale commercial manufacturing. The new facility complements existing small-scale (1,000 L) and large-scale (15,000 L) assets in Visp. In Portsmouth, the company is adding a new biomanufacturing facility for small-to-mid-volume production.

So at the same time that (for example):

• Samsung Biologics invests just south of $2 billion for a new biomanufacturing plant in Incheon, South Korea, which they call (another of their) colossal “bio complexes”; and
• Fujifilm Diosynth Biotechnologies announces North Carolina as the location of a new $1.9-billion large-scale, cell-culture bulk drug-substance biomanufacturing site; and
• Boehringer Ingelheim (BI) plans to inaugurate a new $827-million large-scale, cell-culture biomanufacturing facility in Vienna, Austria, which includes up to 150,000 L manufacturing capacity for BI products and contract manufacturing activities;

CDMOs also seem to have fingers on the pulse of the smaller biopharma-client base. And in fact (as I’ve covered previously), there are also a growing number of “emerging CDMOs” and CDMO models being established precisely to fill the development and smaller capacity space.

Taking all this together, perhaps – over time – we’ll have capacity for all drug sponsors of all sizes.

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Also see:

Cell And Gene Start-Ups Need "CDMO 2.0"
What’s A “Biopharma CDMO”?
Canadian Biopharma “Enables” CDMO For mRNA Vaccine Production