Novel Modalities Spur Shift in Outsourcing Processes and Partnerships

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So far in 2025, BioPharm International® has taken a look at outsourcing in terms of the steps in the processes of developing and producing biologics, analytical technologies that can best align with process monitoring and optimization, and how newly-formed partnerships are helping to ease capacity shortages (1–3). At the same time, innovation continues to push forward, with sustainability and cost savings near the top of the list of priorities (4,5).

The crucial nature of the relationship between sponsor companies and contract development and manufacturing organizations (CDMOs) came into full focus at the Drug, Chemical & Associated Technologies Association (DCAT) Week 2025, where India-based Shilpa Medicare announced that it was launching a full-service, “hybrid” CDMO that aims to adopt a dual approach: offering comprehensive discovery, clinical, and commercial outsourcing services, but also including commercially ready, “off-the-shelf” novel formulations for business-to-business (b2b) licensing (6).

Under multiple roofs

According to Sridevi Khambhampaty, CEO of Shilpa Biologicals, a fully owned subsidiary of Shilpa Medicare, the bio/pharmaceutical industry is constantly evolving both in terms of the technology that is driving innovation in the field, and in novel treatment modalities (7). Because of this, Khambhampaty said, the outsourcing market is continuing to grow, placing even more emphasis on the sponsor–CDMO dynamic.

“With this plethora of technologies and modalities, it’s quite challenging for any company to have all of these under their roof,” Khambhampaty said (7). “So, the small biotechs which want to pursue several new ideas in the novel therapeutic modalities would like to use the CDMO services, because they obviously don’t want to invest in all the capex [capital expenditure] required for taking their ideas to market.”

As both the market itself and the range of outsourced services that are desired have gotten bigger, said John McQuaid, president and managing director of Almac Pharma Services, the strategies of CDMOs have changed by necessity, including, as in Shilpa’s case, starting their own CDMO.

“What started as a largely tactical capacity player for large pharma [companies], and probably what was basic manufacturing and packaging services, I think it’s really turned into something a lot more diverse and strategic in nature,” McQuaid said (7). “Today, CDMOs, we’re important partners for both large and smaller pharma companies. It’s not just capacity that we offer. It’s also technical and scientific knowledge. We have specialisms and technology platforms, and in some cases, proprietary platforms of our own.”

And not only are novel modalities emerging, McQuaid said, but the ones that are driving the most activity have shifted over time. This, he said, has matured the relationships between sponsor companies and CDMOs from at one time being merely transactional to now being closer to true, evenly matched partnerships (7).

“When I started, [outsourcing activity] was dominated by small molecules, and whilst we still see strong demand in this area, we’ve seen higher percentage growth in areas such as biologics, vaccines, [and] cell and gene therapies,” McQuaid said (7). “We’ve got ADCs [antibody-drug conjugates] and of course most recently, peptides. Another trend we’ve definitely seen is the growth in personalized medicines. That’s brought about by better drug target identification, [and] advances in genomics and biomarkers.”

Faster time to market, for all ages

The emergence of personalized medicines is emblematic of a larger trend in customization of services that extend not just to the patient, but within outsourcing partnerships themselves.

“To cater to these diverse modalities. I think flexibility is the key, and being able to offer modular services is also one of the key things,” Khambhampaty said (7). “For example, at Shilpa, we managed to create multiple suites, which I think a lot of the CDMO industry is also adapting to—to be able to make plasmid DNA in one suite, make mRNA [messenger RNA] in one, and then make ADC conjugation in one, and so on and so forth.”

This ideally results, Khambhampaty said, in an increased ability for molecules to be advanced more quickly to the clinical stage, the area in which she sees most of the demand in the CDMO sector currently concentrated with respect to new modalities (7). And to attack that demand on a smaller scale, rather than relying on a large-scale facility, can prove advantageous in the long run.

“A one-stop shop is always welcome, just from the ease of coordination, because you don’t have to deal with multiple partners to get a project done,” Khambhampaty said (7). “But the key advantage [to outsourcing] is that the various moving parts within a project can be handled much better. So, for example, delays, let’s say, in certain upstream processes will impact your downstream and will impact your safe filling. But all of these slots, if they are under the same umbrella—if the same CDMO was doing your drug substance and your drug product—then obviously they will make adjustments to the timelines.”

“On the other hand, while large pharmas are capable of a huge amount of expansive capacity, they often don’t have open capacity, and they want to pursue multiple molecules in their portfolio without having to invest on new capacity,” she continued (7). “So outsourcing is really the only way to get to fast clinical studies, even for the large biopharma [companies].”

One newer focus in expediting drug development is addressing the youngest patient population, according to McQuaid, and that brings its own set of challenges.

“There’s a growing demand for age-appropriate formulations, pediatric drug presentations, so we have to invest and try and get ahead in those areas,” he said (7). “When you look at the cell and gene therapies and biologics, they bring requirements. So, we’re investing in storage and pack, label, and distribution solutions for cold chain products, ultra-low temperature products.”

And when time is of the essence, it may not be the most expeditious approach to have one single company handle everything; however, choosing a partner that has demonstrated experience in as many key areas of development as possible is a wise decision.

“It’s really accelerated time to market that’s certainly in the development sphere, that’s what we hear,” McQuaid said (7). “It’s definitely true that if you can bundle activities, if you can leverage a connected network of internal experts within the CDMO, you can eliminate risk, you can eliminate downtime.”

What clients want

The words “supply chain” became a somewhat dreaded refrain at various points of the COVID-19 pandemic, but in the bio/pharmaceutical industry, keeping the pipeline moving effectively has always been a top objective. And if turning to outsourcing keeps sponsor companies running as cleanly as they can, according to McQuaid, then they are in favor of it. Plus, he said, having the right amount of drug in the right place at the right time is the ultimate goal.

“We definitely see more and more clients with a really strong preference to co locate manufacturing, packaging, release testing, and then the final QA [quality assurance] release and batch release capabilities,” he said (7). “I think for them, that reduces the supply chain burden on themselves, having to manage all those different factors. It can have a financial return in terms of reducing inventory levels—not having to have safety stocks in so many different places—and ultimately, simplifying and de-risking the supply chain.”

At the same time, quality standards, regulatory landscapes, and the challenges of new technologies also continue to evolve along with market demands. This includes the rise of the use of artificial intelligence (AI), which Khambhampaty said can certainly benefit from checks and balances.

“Now, with the advent of AI-based drug discovery, there are a lot of smart scientists who are coming up with designer medicines and virtual labs,” she said. “They do need to find a CDMO to develop their concept to reality.”

“I think ultimately, the clients and pharma companies are seeking best-in-class services,” McQuaid said. “So, I think as CDMOs, we have to be cognizant of that. I think we have to be very transparent about our specialisms. What are our strong points? And if there’s an area that we can’t do, we need to be upfront about that. No one wants to be experimenting on their product.”

Choosing to collaborate with a CDMO is a step more and more sponsor companies have been making in an attempt to speed up timelines of certain drugs they have in development without sacrificing quality. To ensure that, selecting a partner that not only has a flexible knowledge base, but can also reliably deliver on that expertise, is a crucially important decision that neither side of the equation is taking lightly.

References

1. Haigney, S. Steps to Process Development Optimization. BioPharm International 2025, 38 (1) 29–32.
2. Challener, C. A. Outsourcing Analytics for Process Monitoring and Optimization. BioPharm International 2025, 38 (1) 26–28.
3. Lavery, P. Adopting Flexible Strategies to Combat Capacity Shortages. BioPharm International 2025, 38 (3) 31–32.
4. Lavery, P. Savings and Sustainability Sought by Pharma Partners. BioPharm International Bio/Pharma Outsourcing Innovation eBook, February 2025.
5. Haigney, S. Supplying Sustainably. BioPharm International Bio/ Pharma Outsourcing Innovation eBook, February 2025.
6. Shilpa Medicare. Shilpa Launches ‘Hybrid CDMO’ at DCAT. Press Release. March 11, 2025.
7. Thomas, F. Drug Digest: Strategic Partnerships. PharmTech.com, March 28, 2025.

About the author

Patrick Lavery is an Editor for BioPharm International^®.

Article details

BioPharm International®
Vol. 38, No. 4
May 2025
Pages: 6–8

Citation

When referring to this article, please cite it as Lavery, P. Novel Modalities Spur Shift in Outsourcing Processes and Partnerships. BioPharm International 2025 38 (4).