Neeraj Sharma is CEO of Onesource, a global specialty CDMO with end-to-end capabilities in Drug-device combinations, Complex injectables, Biologics and oral technologies. In a discussion with 24/7 Biopharma at CPHI Milan, Sharma opened up about his company’s core strength and how industry tailwinds are propelling the company further in its journey.

When asked about Onesource’s unique value proposition, Sharma pointed to the diversity of services they offer. While he noted that the company may not have the track record of the established big players in some segments, he feels that the company’s “width” of offerings and end to end differentiates it from the herd. A perfect track record in quality and compliance with over 100 customer and regulatory audits, agility and willingness to provide customized solution and investment in state-of-the-art facility for biologics and DDC has enabled OneSource to attract global customers. Company’s biggest draw is their work with drug-device combinations, a technically difficult area to operate in due to the scale of fill-finish and the complexity of the assembly process.

“The biggest part of this value chain is a device itself, and the maximum complexity is around assembling the device, putting the cartridge or a pre-filled syringe into a pen or an auto-injector [and] testing it,” said Sharma. “Because what FDA or EMA look for in a drug device, the maximum time for review is the device itself, and how accurate it’s actually dispensing the drug. And that’s where our expertise is, that we are able to assemble it, we are able to put it together, test it. And that trust is why we have got multiple customers for drug device combinations.”

According to Sharma, this complexity is prohibitive for many CDMOs that may be interested in entering the drug-device space. OneSource has found tremendous success in this niche, and the company is actively working on nine products in the biologics, peptides, and non-peptides spaces, including three GLP-1 projects with global pharmaceutical leaders.

GLP-1s, one of the hottest topics in Milan amid the widespread success of drugs like Ozempic, is one emergent technology OneSource is equipped to work with. Sharma noted that whether its GLP-1s, drug-device combinations, Biologics or Soft Gelatin Capsules, by investing in robust technological processes the company is prepared to pivot to whatever the industry demands.

“The Strides group is known for significant investments in CapEx in the latest technologies,” said Sharma. “We partnered with Pharmagel for Soft gelatin capsules in 90s, invested in isolator technology, in sterile injections, way back in 2015, 2016, when nobody really was looking for it, started working on GLP-1s in 2019Only now FDA is wanting more and more sites to be isolator based, but we invested in that technology. So the group is known for investing in absolute high-tech equipment well ahead of before it becomes a trend. We have never shied away from investment, and we have never really been worried about where the funding is going to come from.”

Similarly, the company is also looking to capitalize on regulatory trends in the broader biopharma market. The pending BIOSECURE Act is positioned to encourage friendshoring, and companies like Onesource are positioned to have a geographic advantage among US-friendly countries due to their relatively low manufacturing costs.

“Finding an alternative to China has already begun, and that continues with or without [BIOSECURE],” said Sharma. “We have seen over the last eight months or so, we have had multiple American multinationals, Japanese multinationals, coming over… we have, right now, multiple open request for proposals (RFPs) from some of the renowned companies on biologics, drug substance, and drug products.”

“So, if you ask me, will all those RFPs close? No. But will some of the RFPs close? Absolutely. We’ll get that business, and if you and I have this pleasure of meeting two years from now, you will see multiple Indian companies, including Onesource, having some good business coming which was maybe originally for China— both as a second source for existing products, and certainly for new products.”