Triangle newcomer Chrysalis offers GMP-ready facilities, expertise; names Plakous 1st NC partner

The average research and development costs of launching a new drug vary widely, a 2021 National Institutes of Health analysis found, but remain very expensive, “…ranging from $161 million to $4.54 billion (2019 US$). Therapeutic area-specific estimates were highest for anticancer drugs (between $944 million and $4.54 billion).”

Larger companies may be able to streamline processes and reduce costs by outsourcing research, development and/or manufacturing to facilities that already meet stringent Food and Drug Administration requirements such as Good Manufacturing Practices (GMP). The designation is critical to ensuring product consistency and safety.

But what about emerging biopharma or medical device companies poised to grow but not yet sufficiently capitalized to build facilities or contract out services? Chrysalis Services LLC, a Research Triangle newcomer, announced Aug. 17 a novel platform that provides risk mitigation and accelerated access to the GMP infrastructure, systems and expertise that biopharma innovators need to advance through each stage of development and manufacturing.

The platform is structured around four connected programs: 

• Chrysalis PILOT™
• Chrysalis ONE™ 
• Chrysalis ADVANCE™ 
• Chrysalis LAUNCH™

It is designed to give biopharma companies the GMP infrastructure, systems, and expertise they need at each stage of development without the burden of building or traditional outsourcing.

In the announcement, Chrysalis CEO Sarah Stevens described the company’s approach: “Each Chrysalis program is designed to provide established, operational GMP infrastructure and expertise that is both fit for purpose and fit for phase.” Each program individually reduces risk, time, and cost of GMP manufacturing while ensuring accelerated access and full control of product and process for those that need it, when they need it, she added.

The platform is structured around four connected programs, Chrysalis PILOT™, Chrysalis ONE™, Chrysalis ADVANCE™, and Chrysalis LAUNCH™. It is designed to give biopharma companies the GMP infrastructure, systems, and expertise they need at each stage of development without the burden of building or traditional outsourcing.

Chrysalis also announced its first platform partner: Plakous Therapeutics, a regenerative medicine company developing novel biologics to address critical unmet needs in neonatal diseases. Plakous, headquartered in Winston-Salem, received a $250,000 Small Business Research Loan in 2022 from the North Carolina Biotechnology Center.

“Access to established, operational GMP infrastructure at the right stage of development is a real challenge for companies advancing novel biologics,” said Robert Boyce, CEO of Plakous Therapeutics. “Partnering with Chrysalis provides us with the infrastructure, systems and expertise we need to advance our therapy toward the clinic and ultimately commercialization with full control of our outcomes and milestones.”

Chrysalis now has three sites: two in Massachusetts, near Boston and Cambridge, and the North Carolina facility in Morrisville, just outside Raleigh and near the Research Triangle Park, announced in July.

Chrysalis Raleigh offers 75,000 square feet of GMP-ready space with 24 modular cleanrooms across 35,000 square feet of temperature-controlled and humidity-monitored space, the company said. Each 750-square-foot suite can be combined to accommodate larger processes or evolving project needs.

Clients also have access to dedicated office and meeting spaces with secure card access, mapped GMP warehousing with ambient and controlled storage, and a staffed shipping and receiving area with a loading dock. Lounge areas and a break room support daily operations and team well-being.

Consistent with the Chrysalis operating model, all clients, from early stage through commercial manufacturing, retain full ownership of their process, product and manufacturing schedule.

Shelly West, vice president of business development at Chrysalis, likened the company’s business model to that of Airbnb. “When you book an Airbnb, you know exactly what you're getting before you arrive, whether it's the number of bedrooms, a fully equipped kitchen or the amenities needed for your stay,” she said. “The space is ready, the infrastructure is in place and support is available if needed, allowing you to focus on your purpose for being there.”

Chrysalis operates similarly for life science companies. “We provide the environment, expertise and flexibility they need to advance their programs, while allowing them to focus on developing life-changing therapies,” West added.

West, who recently joined the Chrysalis team, highlighted the company's shift toward a more flexible business model designed to meet and support companies where they are in their growth journey.

“We're helping innovators move their programs forward more efficiently,” West added. “This approach also creates opportunities for collaboration with contract research organizations and contract development and manufacturing organizations, enabling Chrysalis to serve as an extension of the broader life sciences ecosystem.”

West is optimistic about both the Chrysalis hybrid model and the growing momentum across the life sciences industry. “We are definitely seeing an increase in activity and engagement from companies looking for more flexible ways to access GMP infrastructure,” she said.

“It’s an exciting time to be a part of the industry, and I’m looking forward to connecting with innovators, entrepreneurs and life science leaders throughout the region,” West added. She has already begun meeting with clients and building new relationships and looks forward to welcoming the life sciences community to the Chrysalis open house in September.