Avid Bioservices Completes Construction of New, World-Class Cell and Gene Therapy Development and Manufacturing Facility
17 Octubre 2023 - 7:05AM
Avid Bioservices, Inc. (NASDAQ:CDMO), a dedicated biologics
contract development and manufacturing organization (CDMO) working
to improve patient lives by providing high quality development and
manufacturing services to biotechnology and pharmaceutical
companies, today announced that it has completed construction of
CGMP manufacturing suites within its new, world-class cell and gene
therapy (CGT) development and CGMP manufacturing facility as
scheduled. The newly launched CGMP manufacturing suites are
currently undergoing final environmental monitoring and performance
qualification. With the completion of this latest and final
expansion project, Avid estimates that its combined facilities now
have a potential total revenue generating capacity of up to
approximately $400 million annually.
The purpose-built 53,000 square foot CGT
development and manufacturing facility will support early-stage
development through commercial manufacturing and is located in
Orange County, CA, just five miles from Avid’s mammalian
development and manufacturing operations. The recently completed
manufacturing suites join the CGT facility’s analytical and process
development labs, which were launched in 2022. Avid plans to
commemorate the completion of the CGT facility by hosting a
celebratory grand opening in January 2024.
“Over the past few years, we have implemented a
strategic expansion plan designed to grow both our capacity and
capabilities to align with the demands of the evolving
biopharmaceutical market. With the completion of our CGT facility
and launch of its CGMP manufacturing suites, we have now completed
all phases of that expansion plan and find ourselves strongly
positioned to meet the needs of our current and future customers,”
said Nick Green, president and chief executive officer of Avid
Bioservices. “The completion of this expansion is another example
of the Avid team’s ability to execute. The facility’s completion
comes only 24 months after we first broke ground and, when allied
with the other activities and expansions undertaken by the team
during this period, represents a significant achievement. We look
forward to engaging with customers and offering them the full range
of capabilities necessary to serve their needs along with Avid’s
significant experience of operating CGMP-compliant facilities.”
Avid’s CGT facility will have the capability to
produce suspension culture batches of up to 3,000 liters, as well
as adherent cultures utilizing fixed bed bioreactors. Additionally,
the manufacturing suites are designed to produce drug product with
the use of state-of-the-art filling and capping machinery performed
under isolator. With over 6,000 square feet dedicated to quality
control laboratory space, the facility will be fully equipped to
support both clinical and commercial CGT products.
“As more and more clinical successes are
achieved in the cell and gene therapy space, we will continue to
see increasing demand for CDMOs with extensive commercial
manufacturing experience and mature, well-tested quality systems.
Avid Bioservices is very well positioned through our new CGT
facility and experienced team to produce these life-saving
therapies for the benefit of patients around the world,” said Drew
Brennan, general manager of viral vector technologies of Avid
Bioservices.
About Avid Bioservices, Inc.
Avid Bioservices (NASDAQ:CDMO), an S&P
SmallCap 600 company, is a dedicated contract development and
manufacturing organization (CDMO) focused on development and CGMP
manufacturing of biologics. The company provides a comprehensive
range of process development, CGMP clinical and commercial
manufacturing services for the biotechnology and biopharmaceutical
industries. With 30 years of experience producing biologics, Avid's
services include CGMP clinical and commercial drug substance
manufacturing, bulk packaging, release and stability testing and
regulatory submissions support. For early-stage programs the
company provides a variety of process development activities,
including cell line development, upstream and downstream
development and optimization, analytical methods development,
testing and characterization. The scope of our services ranges
from standalone process development projects to full development
and manufacturing programs through
commercialization. www.avidbio.com
Forward-Looking Statements
Statements in this press release which are not
purely historical, including statements regarding Avid Bioservices,
Inc.'s intentions, hopes, beliefs, expectations, representations,
projections, plans or predictions of the future, are
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements involve risks and uncertainties including, but not
limited to, the risk that the company may experience delays in
hiring qualified individuals into the viral vector business, the
risk that the company may experience delays in engaging initial
customers for the viral vector business, and the risk that the
viral vector business may not become profitable for several years,
if ever . Our business could be affected by a number of other
factors, including the risk factors listed from time to time in our
reports filed with the Securities and Exchange
Commission including, but not limited to, our annual report on
Form 10-K for the fiscal year ended April 30, 2023, and
subsequent quarterly reports on Form 10-Q, as well as any updates
to these risk factors filed from time to time in our other filings
with the Securities and Exchange Commission. We caution
investors not to place undue reliance on the forward-looking
statements contained in this press release, and we disclaim any
obligation, and do not undertake, to update or revise any
forward-looking statements in this press release except as may be
required by law.
Investor Relations:
Stephanie Diaz
Vida Strategic Partners
415-675-7401
sdiaz@vidasp.com
Media Relations:
Tim Brons
Vida Strategic Partners
415-675-7402
tbrons@vidasp.com
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