Avid Bioservices Announces Launch of Analytical and Process Development Suites Within New, World-Class Viral Vector Development and Manufacturing Facility
June 14 2022 - 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 the opening of the analytical and
process development (AD/PD) suites within the company’s new,
world-class viral vector development and CGMP manufacturing
facility. The launch of the AD/PD labs comes eight months to the
day that Avid announced its intention to expand its CDMO service
offering into the rapidly growing cell and gene therapy market.
Build-out of the viral vector facility’s CGMP manufacturing suites
is ongoing, with those capabilities expected to come online in
mid-calendar 2023.
The company’s new AD/PD labs are equipped with
complete upstream, downstream and analytical development
capabilities and are able to support up to 500 liter suspension
culture in single-use bioreactors and various adherent cell modes.
The company’s viral vector AD/PD team, which is led by Elie G.
Hanania, Ph.D., has deep expertise in developing and implementing
state-of-the-art enabling technologies for viral vector production
and purification processes focused on adeno-associated viruses
(AAVs), lentiviruses, oncolytic viruses and other viruses for gene
therapy and vaccine applications.
“Avid’s entry into the cell and gene therapy
sector is a critical component of the company’s growth strategy
over both the short- and long-term. We believe that we are uniquely
positioned to leverage our deep expertise in the manufacturing of
traditional biologics to address the growing demand for high
quality manufacturing of cell and gene therapies,” said Nick Green,
president and chief executive officer of Avid Bioservices.
“Today’s launch of our AD/PD labs is a crucial first step in our
expansion into the viral vector space as we remain laser focused on
smart and sustainable revenue growth for our business. We now look
forward to engaging in a meaningful way with potential viral vector
clients and offering this latest tangible evidence of the quality
of Avid’s facilities and the capabilities of our team.”
In October 2022, Avid announced plans to
construct a purpose-built 53,000 square foot viral vector facility
in Costa Mesa, CA, approximately five miles from Avid’s existing
operations in Tustin, CA. The strategic decision was driven by
continued strong growth in the cell and gene therapy market
combined with the CDMO industry’s overall lack of proven,
high-quality CGMP manufacturing expertise and capacity for viral
vectors. With more than 17 years of experience in commercial
manufacturing of biologics underpinned by a strong quality ethos
and a customer-centric approach to doing business, Avid offers a
strong value proposition to prospective customers in the cell and
gene therapy market.
“The opening of our newly constructed viral
vector process and analytical development laboratories within eight
months of our announced investment is truly a testament to the
capability and dedication of our Avid team, as well as our partners
at CRB. We are excited to begin working on customer projects
in this new facility and look forward to completing the ongoing
construction of our new vial vector CGMP manufacturing suites,”
said Drew Brennan, general manager of viral vector technologies of
Avid Bioservices.
About Avid
Bioservices, Inc.
Avid Bioservices 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 28 years of
experience producing monoclonal antibodies and recombinant
proteins, 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 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 the
construction of viral vector facility, the risk that expanding into
a new biologics manufacturing segment may distract senior
management’s focus on the company’s existing operations and/or its
current expansion of the Myford facility, 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, 2021 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.
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
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