Scorpius Holdings Achieves Major Milestone with cGMP Facility Validation for Microbial Manufacturing
15 Maio 2024 - 9:00AM
Scorpius Holdings, Inc (NYSE
American: SCPX), (“Scorpius” or the
“Company”), an integrated contract development and manufacturing
organization (CDMO), today announced the successful validation of
its microbial facilities, marking a significant milestone in the
Company's operations. This validation signifies that Scorpius’
microbial cleanrooms are now officially approved to manufacture
current Good Manufacturing Practice (cGMP) microbial biologic
drugs, underscoring the Company's commitment to quality and
regulatory compliance.
Scorpius facilities have already garnered considerable interest,
with a backlog of bookings from client programs. This achievement
not only demonstrates Scorpius' capability to meet the regulatory
and client driven high standards required for contract
manufacturing of microbial biologics but also highlights the trust
and confidence its clients place in its services.
In conjunction with the facility qualifications, Scorpius is
also streamlining its operations by transitioning environmental
monitoring responsibilities to internal teams, while it migrates
from the previous reliance on third-party services. This shift is
expected to allow for greater efficiency, further enhancing the
Company's robust ability to deliver high-quality biomanufacturing
services.
“Scorpius has experienced strong interest in our microbial
capabilities, and we continue to add additional opportunities to
our pipeline for 2024 and 2025,” stated Jeff Wolf, CEO of Scorpius
Holdings. “This validation confirms our commitment to high-quality,
state-of-the-art microbial production. We are dedicated to
leveraging our advanced capabilities to support our clients' needs
and contributing to the advancement of breakthrough therapies.”
“This validation is a testament to Scorpius’ rigorous quality
standards and our dedication to supporting the development and
manufacturing of microbial products. With this achievement,
Scorpius is poised to further solidify its position as a leader in
clinical scale microbial manufacturing, offering our clients
unparalleled quality and service,” concluded Wolf.
Scorpius Holdings, Inc.
Scorpius Holdings Inc. is an integrated contract
development and manufacturing organization (CDMO) focused on
rapidly advancing biologic and cell therapy programs to the clinic
and beyond. Scorpius offers a broad array of analytical testing,
process development, and manufacturing services to pharmaceutical
and biotech companies at its state-of-the-art facilities in San
Antonio, TX. With an experienced team and new, purpose-built U.S.
facilities, Scorpius is dedicated to transparent collaboration and
flexible, high-quality biologics biomanufacturing. For more
information, please visit www.scorpiusbiologics.com.
Forward-Looking Statement
This release contains forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995. In some cases, forward-looking statements can be
identified by terminology such as "may," "should," "potential,"
"continue," "expects," "anticipates," "intends," "plans,"
"believes," "estimates," and similar expressions, and include
statements such as the transition of environmental monitoring
responsibilities from third-parties to internal teams being
expected to allow for greater efficiency, further enhancing the
Company's robust ability to deliver high-quality biomanufacturing
services; continuing to add additional opportunities to the
Company’s pipeline for 2024 and 2025; Scorpius being poised to
further solidify its position as a leader in clinical scale
microbial manufacturing, offering our clients unparalleled quality
and service. Important factors that could cause actual
results to differ materially from current expectations include,
among others, the Company’s ability to continue to validate its
microbial facilities; expand its large molecule biomanufacturing
CDMO services and continue to grow revenue; the Company’s financing
needs, its cash balance being sufficient to sustain
operations and its ability to raise capital when needed, the
Company’s ability to leverage fixed costs and achieve long-term
profitability; the Company’s ability to obtain regulatory
approvals or to comply with ongoing regulatory requirements,
regulatory limitations relating to the Company’s ability to
successfully promote its services and compete as a pure- play
CDMO, and other factors described in the Company’s annual report on
Form 10-K for the year ended December 31, 2023, subsequent other
filings the Company makes with the SEC. The information in this
presentation is provided only as of the date presented, and the
Company undertakes no obligation to update any forward-looking
statements contained in this presentation on account of new
information, future events, or otherwise, except as required by
law.
Media and Investor Relations
ContactDavid Waldman+1 919 289
4017ir@scorpiusbiologics.com
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