The US has opportunity to bring new efficiencies to advanced biologics manufacturing

By Rachel Arthur contact

- Last updated on GMT

Pic:getty/shulz
Pic:getty/shulz

Related tags: Biologics, Us, CDMO, cell and gene therapies, ATMPs, Vaccines, mRNA

The US will play a key role in the development of advanced manufacturing technologies, predicts a report commissioned by CPhI North America ahead of the 2022 show.

While the country cannot compete on labour costs, it has the scope to bring new tech and efficiencies to advanced biologics manufacturing, say experts.

CDMOs in particular have the chance to drive the advancement of technologies and make the US a center for biologics manufacturing. 

High demand and capacity constraints

Previous decades have seen a drift away from US pharma manufacturing and domestic contract services. But macro changes - accelerated by the pandemic - are reversing this.

In particular, the report identifies growth for high value manufacturing areas, such as high potent and complex APIs, biologics and cell and gene therapies (absolute growth across biologics, biosimilars and cell and gene technologies is expected to amount to $133bn between 2019 and 2023, according to Results Healthcare – although this estimate pre-dates the pandemic which has added billions of dollars worth of contracts for fill-finish vaccines, adjuvants and viral vectors).

The result is capacity constraints: with both CDMOs and innovators now looking to expand capacity significant.

There are particular opportunities for the US to lead in advanced biologicals. In addition, mRNA-based vaccines and therapies and vector manufacturing for recombinant vector vaccines, gene therapy and gene modified cell therapy are other areas to watch. Manufacturing capacity for cell and gene therapies was already strained before the pandemic, and now is under further pressure because vaccines use a lot of the same technology and raw materials.

Getting ahead

As new drugs enter the market, many will require entirely new manufacturing processes. This gives US manufacturers and CDMOs the chance to get ahead of the game with purpose-built facilities.

Given the ongoing capacity constraints in biologics, the report envisions a change in approach from biotech innovators, with capital raised earlier to build clinical and commercial manufacturing sites. This puts the larger CDMOs – with a greater access to capital – ahead.

However, it’s not just manufacturing that can benefit. If companies can get ahead in the development process, that also sets up the US industry for success.

“While at the start of the adoption curve, advances in AI and drug target development technologies are also opening up the potential for some returning discovery and early-stage development work being run in the US," ​notes the report.

"These technologies potentially mean companies can review hundreds of targets simultaneously and come with the obvious advantages of closer collaboration between innovators and development teams.

"What we’ll likely see over the next few years is the increase in biotechs using US partners for computational processes to explore target options, chemistries and biologies – as opposed to the recent modus operandi of outsourcing chemistry services to Asia.”

Bright future for US CDMOs

With the high demand for biologicals, cell and gene therapies, vaccines and more, there’s ‘huge opportunities’ within the CDMO space, says the report.

For example, there are only 87 viral vector contract manufacturing facilities worldwide, according to GlobalData’s 2021 research. Experts suggest that standardized viral platforms could be used interchangeably by therapy developers, potentially speeding up cell and gene therapies’ development, approval, and technology transfer to CDMOs.

Furthermore, CDMOs are helping bringing potentially cost and time saving continuous processes to market more quickly: building trust and providing guidance to biotech partners less familiar with the regulatory process.

And large CDMOs have the opportunity to use their available capital to create purpose-built facilities in anticipation of a growing number of biologics.

Continuous processing

Another area of US leadership is continuous processing: with CDMOs helping to bring this to the market more quickly with their expertise.

Despite slow adoption over the last five years, the report says the industry is now at a ‘tipping point’ as a number of continuous lines start commercial production.

In the biologics space, the industry is continually looking for new innovations in upstream and downstream processing.

“Innovation in manufacturing will be required for the production volumes necessary for the widespread use of advanced biologics, as well as the reduction in price of these therapies; just as innovation was previously involved in the popularization of monoclonal antibodies,"​ notes Peter Shapiro, senior director of drugs and business fundamentals at GlobalData in the report.

"There are already large market-based incentives for success in increasing the efficiency and volumes of advanced biologic production."

Related topics: Upstream Processing

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