Scorpius to Unveil First Mammalian cGMP Campaign at Texas Plant

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The San Antonio facility will be taking this biomanufacturing initiative by the end of Q3 2024.

Image Credit: Adobe Stock Images/F11Photo.com

Image Credit: Adobe Stock Images/F11Photo.com

Scorpius Holdings, Inc., a contract development and manufacturing organization (CDMO), is planning on launching its first current good manufacturing practice (cGMP) mammalian manufacturing campaign at its San Antonio, TX facility in Q3 2024.1 The news represents growth of the company’s biomanufacturing services, specifically when it comes to mammalian cell culture production for advanced biopharmaceuticals.

At its microbial facilities, the CDMO already had cGMP activities in the works, but the unveiling of these mammalian cGMP services opens new revenue streams for its operations. The mammalian cell culture facility contains a multitude of manufacturing solutions, including cGMP-compliant controlled cleanrooms.

“I am extremely proud of what our team has accomplished in a short period of time. Our manufacturing and quality teams have worked exceptionally hard to get our mammalian facilities operational in less than two years, well ahead of the typical timing for such complex buildouts,” said Jeff Wolf, CEO of Scorpius. “Scorpius is now extremely well-positioned to support a wide range of early-stage clinical programs.

“Our focus at Scorpius is providing each client the personalized attention and systematic flexibility they deserve. Our facility's design includes cleanrooms with mobile equipment, allowing for easily customized configurations to meet the specific needs of each project. Our strategy is to expand our scope of services as our clients advance their respective programs through clinical development. Looking ahead, Scorpius has already secured bookings for additional cGMP activities in the mammalian building for 2025, demonstrating the demand and confidence in our expanded capabilities.”

It's also important to note this announcement comes off the heels of expanding the size of Scorpius’ San Antonio warehouse facilities by more than sevenfold—from about 3,000 square feet to 21,000 square feet—with the opening of a new storage and testing plant.2

The project features specialized storage areas that are able to maintain temperatures between -20°C and -80°C for raw materials; there is also dedicated space for contained sampling and quality control testing. It will even house bulk drug substance storage, allowing for storage (in desired temperatures) throughout both the development and production cycles.

"These new capabilities enable us to offer our clients continuity through their supply chain and meet their needs from process development through drug substance release. This strategic expansion reflects our commitment to excellence and our dedication to supporting our clients’ overall needs, Wolf added."

In relation to boosting biomanufacturing productivity and efficiency, time will also tell as to the impact that advanced AI robotics will have in the Scorpius’ workflow—last month, the CDMO reached a strategic partnership3 with Beyond Imagination, Inc. The plan is to address the rise in demand for rapid-scale biomanufacturing, combined with limited supply of labor.

“This partnership marks a major advance in the integration of advanced AI robotics into vital sectors, setting the foundation for a future where technology and human expertise align to transform the biomanufacturing and pharmaceutical industries,” commented Dr. Harry Kloor, PhD, executive co-founder and CEO of Beyond Imagination. “We are excited to work closely with the Scorpius team to improve biomanufacturing production for the benefit of customers and ultimately patients.”

References

1. Scorpius Holdings Set to Launch First Mammalian cGMP Campaign at San Antonio Facility in the 2024 3rd Quarter. Scorpius Holdings, Inc. July 24, 2024. Accessed July 24, 2024. https://ir.scorpiusbiologics.com/news-events/press-releases/detail/758/scorpius-holdings-set-to-launch-first-mammalian-cgmp-campaign-at-san-antonio-facility-in-the-2024-3rd-quarter

2. Scorpius Holdings Announces Major Expansion in San Antonio with New State-of-the-Art Storage and Testing Facility. Scorpius Holdings, Inc. May 20, 2024. Accessed July 24, 2024. https://ir.scorpiusbiologics.com/news-events/press-releases/detail/754/scorpius-holdings-announces-major-expansion-in-san-antonio-with-new-state-of-the-art-storage-and-testing-facility

3. Scorpius Holdings and Beyond Imagination Announce Trailblazing Partnership to Utilize Autonomous AI-Powered Humanoid Robots for American Biomanufacturing. Scorpius Holdings, Inc. June 3, 2024. Accessed July 24, 2024. https://ir.scorpiusbiologics.com/news-events/press-releases/detail/756/scorpius-holdings-and-beyond-imagination-announce-trailblazing-partnership-to-utilize-autonomous-ai-powered-humanoid-robots-for-american-biomanufacturing

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