Shaping The Future Of GLP-1 Quality

By Katie Anderson, Chief Editor, Pharmaceutical Online

It seems like GLP-1 analogs are always front and center in the day’s news. As of recent, Eli Lilly announced a $1.2 billion dollar investment in a Puerto Rican manufacturing facility to accommodate production of its oral GLP-1 pill and Novo Nordisk’s engaged in a  somewhat unfriendly competition with Pfizer to acquire Metsera.

GLP-1 analogs are always in the news, and that fact isn’t going to change anytime soon, with the drug category anticipating a 17.46% CAGR into 2030.¹ With this exploding demand, manufacturers are left to troubleshoot how to make enough GLP-1 demand without sacrificing quality.

Three experts—Doug Bakan (CTO of Kailera), Hyung Heon Kim (CEO of MetaVia) and Deepa Nagpal (Founder of SygnifyQ)—joined us on Oct. 15, 2025, to explore this topic, find out the most common quality failures, learn what innovation is occurring and find out what business decisions can help support both quality and quantity.

The Demand and Innovation

With the initial popularity of GLP-1 drugs, the industry was not prepared, according to Nagpal. She noted, “Organizations were not prepared for such a huge demand, so the production lines were way behind the expected requirement.” She furthered that the pandemic complicated the production by creating issues with the supply chain. To mitigate the trouble with demand, GLP-1s were put on a drug shortage list, freeing up compounding pharmacies to profit off their own versions. Problem was, not everyone has the expertise and capability to produce such drugs. “These are not simple projects, specifically with peptides. You have to have the expertise to do it well,” noted Bakan.

The industry was then tasked with increasing quantity to unprecedented levels, but keeping the quality high. Bakan believes the issue in quantity is different depending on company size. He explained that while large GLP-1 manufacturers have invested in facilities to meet the demand, that frees up CDMO space to answer the quantity for small to mid-size manufacturers. “These smaller CDMOs have recognized the potential to have these enormous quantities of drug product that needs to be supplied. They say, not only can we supply a certain amount of material today, but we want to grow with you and we want to continue to expand,” he added, noting optimism in answering future demand.

Demand and quality have both been addressed with innovation. As far as delivery goes, Kim has seen innovation in presentation form, including new forms such as dry vials.

Nagpal continued that she has been innovation in production. “Established manufacturers have implemented continuous manufacturing and real time release processing (real time testing), which has sped up the process with respect to the production of a batch,” she explained.

Meanwhile, Bakan noted innovation in the manufacturing of the peptides themselves. “Some manufacturers are using liquid phase peptide synthesis or recombinant technology (fragmentation approaches), which is another way to increase the scale but also to reduce the cost,” added Bakan.

Failures in Quality Control and Solutions

Thanks to innovation, expansion and new partnerships, supply is well on its way to increasing to meet demand. But, is quality being sacrificed? With the proper steps, the experts say no.

Bakan highlighted the two most common quality issues he sees are in sterility and analytical methodologies. His team keeps a close eye on its sterility, complying with the annex-1 changes, and tries to take the human component out of aseptic processing as much as possible.

He has also seen quality failures in analytical methodologies. “We have to develop super solid analytical methodologies to make sure we are accurately characterizing the impurity profiles of these molecules, and I think that is where the failure can come in,” he added.

Nagpal emphasized that companies need to spend more time in the beginning developing its processes before it gets into manufacturing. “The analytical teams don’t really get enough time, and budget is always a major issue. We should be investing enough in analytical methods,” Nagpal explained.

In addition to investing in the analytical assays early, Bakan believes firmly in mindset. “We always want to have the mindset of continuous improvement. We will continue to refine our analytical assays, because we know that things can happen at scale-up.”

Adaptations to the Process and Scale-up

Speaking of scale-up, the panelists agreed that scale-up was less of a concern when it came to supply now than in years past. Bakan did add that procuring equipment for scale up could be an issue.

“If you need to add change parts or something like that [on equipment], there still to be quite a long lead time on those things. So that's a hurdle that we have towards scale-up is to making sure that the process train or the manufacturing train itself is set up to produce at the scale that we want to,” Bakan furthered. To combat that, Bakan recommended having a network of suppliers who can each contribute to your company’s needs for scale up.

Though changes to the process do happen, it is vital to have a change control process in place, according to Nagpal. “When you're making changes, you have a robust system to track the changes down,” she noted.

Bakan agreed, adding that he has to have confidence that the change is going to make a realistic difference. “The last thing you want to do is sort of fix something that isn't broken, but you always want to advance and continuously improve,” said Bakan.

In the batch vs. continuous manufacturing conversation, though, Nagpal noted that batch is the way to go early on, but continuous manufacturing can be implemented once you have a fully developed process. “Obviously, it comes with a lot of risk. You have to monitor your process as you go along. It definitely speeds up your process, but on the other hand, you're taking the risk of losing the batch if something goes wrong,” she added.

Addressing The Business Side

In the last portion of the virtual GLP-1 panel, the experts talked business, namely supply chain, regulatory and tech transfer.

Kim hasn’t really seen an issue with supply chain, and Bakan agreed. Though, they both agreed that diversifying the supply chain is the best practice. “We try to introduce geographical diversity, corporate diversity and duplication. We really want to have networks of suppliers that if things go south in one area of the world, we can maybe compensate by dialing up our production in the other side,” added Bakan. He also commented, “My least favorite phrase is I am single sourced, and he did not that having both a peptide and small molecule version of GLP-1 analogs automatically diversified his supply chain.

When it comes to regulation, Nagpal recommended to not be afraid to rely on the FDA, adding, “Reach out to them if you have questions regarding your clinical protocol or your manufacturing. They want to help you.”

Bakan furthered that his teams strives to get their hands on all the regulatory information they can to be adequately prepared for the FDA’s needs. “You've got to have an understanding of what those agencies are going to expect when your product gets to that point of regulatory approval. We try and keep a very close eye on anything that's publicly available information.”

When it comes to tech transfer, all three experts agreed that communication and preparation are key. Nagpal recommended doing a pilot batch first, and of course, making sure all your cQAs and CPPs are in place. Bakan added that “you can’t overcommunicate,” when it comes to tech transfers, furthering, “You can't underestimate the importance of having a quality agreement set up early so that you know that you're playing by the same rules.”

Kim concluded that you can’t rush anything when it comes to tech transfer. He recommended making sure you are adequately prepared and that you have allotted enough time.

The panelists concluded the panel by agreeing that you can’t cut corners when it comes to quality. Nagpal put it simply, “Don’t cut on quality, because the patient comes first,” and Bakan furthered, “You got to put the time in early.” Though innovation certainly helps when it comes to both increasing supply and quality, it seems that preparation, communication, adaptation and documentation are really the stars of the show when it comes to matching GLP-1 demand with quality.

You can watch the entire event for free thanks to our event sponsor, Waters. On that web page, you’ll also find links to other in-depth segments from the discussion. We host these types of panel discussions regularly throughout the year, so stay tuned to Pharmaceutical Online Live for more expert insights on topics ranging from sustainability to aseptic processing and more.