Societal CDMO Announces Key New Customer Project Within Automated Fill/Finish and Lyophilization Unit at San Diego Facility
08 June 2022 - 9:00PM
Societal CDMO, Inc. (“Societal CDMO”; NASD: SCTL), a contract
development and manufacturing organization (CDMO) dedicated to
solving complex formulation and manufacturing challenges primarily
in small molecule therapeutic development, today announced a key
new customer project utilizing its automated fill/finish line and
lyophilization unit at the company’s San Diego facility. The
recently initiated project is focused on formulation development
and sterile GMP manufacturing of a lyophilized novel cancer
therapeutic for intravenous infusion. Societal has been contracted
by an emerging Japan-based biopharmaceutical company to conduct
this work in support of the company’s ongoing clinical development
of the compound as a potential treatment for solid tumors.
Societal’s aseptic fill/finish suite features a
sterile, automated vial filling system with the capability to fill
up to 2,000 presterilized vials per hour at a range of volumes. The
company’s lyophilization offering incorporates a novel, patented
approach to uniformity and instantaneously induces nucleation via
pressurization and depressurization. This equipment provides the
capacity for lyophilization of approximately 9,000 10 mL vials
during each 3-5 day freeze-drying cycle.
“Our decision to add fill/finish and
lyophilization capabilities to our suite of CDMO services was
driven by the opportunity to unlock an additional revenue source
for the company and further our goal of providing end-to-end CDMO
services for our customers. With ongoing customer activities moving
through our fill/finish and lyophilization unit, we are now
directly realizing those important benefits that triggered this
strategic service expansion,” said David Enloe, chief executive
officer of Societal CDMO. “It is important to note that we are
undertaking this project on behalf of a Japan-based biopharma,
which we believe is yet another example of a growing interest among
ex-U.S. drug developers to conduct critical CDMO activities within
the U.S. As such, we expect that having a bi-coastal base of
operations in the U.S. will continue to serve as a competitive
advantage for Societal.”
About Societal CDMOSocietal
CDMO (NASDAQ: SCTL) is a bi-coastal contract development and
manufacturing organization (CDMO) with capabilities spanning
pre-Investigational New Drug (IND) development to commercial
manufacturing and packaging for a wide range of therapeutic dosage
forms with a primary focus in the area of small molecules. With an
expertise in solving complex manufacturing problems, Societal CDMO
is a leading CDMO providing therapeutic development, end-to-end
regulatory support, clinical and commercial manufacturing, aseptic
fill/finish, lyophilization, packaging and logistics services to
the global pharmaceutical market.
In addition to our experience in handling DEA
controlled substances and developing and manufacturing
modified-release dosage forms, Societal CDMO has the expertise to
deliver on our clients’ pharmaceutical development and
manufacturing projects, regardless of complexity level. We do all
of this in our best-in-class facilities, which total 145,000 square
feet, in Gainesville, Georgia and San Diego, California.
Societal CDMO: Bringing Science to Society. For
more information about Societal CDMO’s customer solutions, visit
societalcdmo.com.
Forward-Looking StatementsThis
press release includes forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. The words “anticipate”,
“believe”, “could”, “estimate”, “upcoming”, “expect,”, “intend”,
“may”, “plan”, “predict”, “project”, “will” and similar terms and
phrases may be used to identify forward-looking statements in this
press release. Our operations involve risks and uncertainties, many
of which are outside our control, and any one of which, or a
combination of which, could materially affect our results of
operations and whether the forward-looking statements ultimately
prove to be correct. Factors that could cause the company’s actual
outcomes to differ materially from those expressed in or underlying
these forward-looking statements include risks and uncertainties
associated with the ongoing economic and social consequences of the
COVID-19 pandemic, inflation and global instability, including
political instability, including any adverse impact on the customer
ordering patterns or inventory rebalancing or disruption in raw
materials or supply chain; demand for the company’s services, which
depends in part on customers’ research and development and the
clinical plans and market success of their products; customers’
changing inventory requirements and manufacturing plans; customers
and prospective customers decisions to move forward with the
company’s manufacturing services; the average profitability, or
mix, of the products the company manufactures; the company’s
ability to enhance existing or introduce new services in a timely
manner; fluctuations in the costs, availability, and suitability of
the components of the products the company manufactures, including
active pharmaceutical ingredients, excipients, purchased components
and raw materials, or the company’s customers facing increasing or
new competition. These forward-looking statements should be
considered together with the risks and uncertainties that may
affect our business and future results presented herein along with
those risks and uncertainties discussed in our filings with the
Securities and Exchange Commission at www.sec.gov. These
forward-looking statements are based on information currently
available to us, and we assume no obligation to update any
forward-looking statements except as required by applicable
law.
Contacts:
Stephanie Diaz (Investors)
Vida Strategic Partners
415-675-7401
sdiaz@vidasp.com
Tim Brons (Media)
Vida Strategic Partners
415-675-7402
tbrons@vidasp.com
Ryan D. Lake (CFO)
Societal CDMO
770-531-8365
ryan.lake@societalcdmo.com
Societal CDMO (NASDAQ:SCTL)
Historical Stock Chart
From Apr 2024 to May 2024
Societal CDMO (NASDAQ:SCTL)
Historical Stock Chart
From May 2023 to May 2024