Scorpius Holdings Prepares for Mammalian CGMP Manufacturing Campaign Launch in Texas Facility

Editor's note: this story was originally published on BioPharmInternational.com.

Scorpius Holdings, an integrated contract development and manufacturing organization (CDMO), is prepared to launch its first current good manufacturing practice (CGMP) mammalian manufacturing campaign at its manufacturing facility in San Antonio, Texas, in the 2024 third quarter. The launch follows the company's expansion efforts for its biomanufacturing capabilities, especially in the area of mammalian cell culture for advanced biopharmaceuticals, according to a July 24, 2024 press release.

The company previously started up CGMP operations at its microbial manufacturing facilities, and the start of mammalian CGMP manufacturing campaigns signifies a strategic company milestone in its CDMO operations. The San Antonio site hosts a dedicated mammalian cell culture facility with CGMP-compliant controlled cleanrooms that can be tailored to allow for adaptable manufacturing solutions, according to a company press release.

“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. Scorpius is now extremely well-positioned to support a wide range of early stage clinical programs," said Jeff Wolf, CEO of Scorpius, in the press release.

The facility’s design includes cleanrooms with mobile equipment, which enables customizable configurations for the specific needs of individual projects. Scorpius has secured bookings for additional CGMP activities in the mammalian facility for 2025, according to Wolf in the press release.

The San Antonio site underwent significant expansion in May 2024 as Scorpius grew its operational footprint. The expansion included new storage space and a testing facility. Warehouse space was increased more than sevenfold, from approximately 3000 ft2 to approximately 22,000 ft2 with the expansion. The warehouse includes specialized storage areas with temperature control between -20 °C and -80 °C for raw materials as well as spaces designated for contained sampling and quality control testing. The facility will also accommodate bulk drug substance storage to ensure that products are stored under optimal conditions throughout the development and production cycles. (1).

The expanded facility will include a robust stability program meant to bolster Scorpius' service offerings by allowing the company to provide in-house stability storage capabilities. The company intends to foster smooth transitions into onsite testing with the enhanced in-house stability storage.

"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 said in a May 20, 2024 company press release.

Reference

1. Scorpius Holdings. Scorpius Holdings Announces Major Expansion in San Antonio with New State-of-the-Art Storage and Testing Facility. Press Release, May 20, 2024.

Source: Scorpius Holdings