CAPACITY TO ACCELERATE SUCCESS
BEYOND YOUR TYPICAL CMOINTEGRATED, COMPREHENSIVE, FLEXIBLE
Avid Bioservices is a Contract Manufacturing Organization (CMO) with the
capacity to accelerate success. As a CMO partner, we provide fully integrated
services across the process chain to develop and commercialize a biologic,
including cell line and process development, analytical methods development,
clinical and commercial cGMP biomanufacturing, and regulatory submissions.
We provide first-hand expertise and knowledge to navigate a biologic
from concept to commercialization, since we are a wholly-owned subsidiary
of Peregrine Pharmaceuticals, a clinical-stage, publicly traded biotech
company with a management team experienced in the development and
commercialization of therapeutic proteins. This allows us to offer Clients
unique insight to manage the process, scale-up and validation challenges
of drug development and commercialization while mitigating risk, reducing
costs and accelerating time to market.
Our Clients benefit not only from our comprehensive service offerings,
but also from the experience that comes from navigating our own products
through development.
LET OUR EXPERIENCE DRIVE YOUR SUCCESS
Our fully integrated service offerings
allow us to streamline the process by
executing multiple parts simultaneously
and effectively utilizing the process
results in subsequent and ongoing
processes. Through all stages of the
project we ensure seamless transitioning
and provide the Client with a single point
of contact to simplify the dissemination of
project information.
Avid strives to be the partner of choice
by providing a more comprehensive
approach to development and
biomanufacturing contract services to
meet the market demand. Manufacturing
biologics for our Clients, including our
parent company, enables us to provide
guidance outside the realm of a typical
CMO, in addition to providing flexible
solutions.
Our facility currently has 2,650 liters
of total capacity with the potential
for expansion of an additional 6,000
liters, taking advantage of disposable
technology.
We pride ourselves on being able to apply
our knowledge and experience to benefit
our Clients and their projects throughout
the process. Our manufacturing expertise
spans from clinical to commercial
production, including commercial API
production since 2005.
DEDICATED TO PRE-CLINICAL THROUGH COMMERCIAL
PRODUCTION OF MAMMALIAN CELL CULTURE BIOLOGICS
CELL LINE DEVELOPMENT
Cell line development & selection
Cell line characterization & optimization
Cell banking (MCB/WCB/RCB)
Cloning & subcloning
PROCESS DEVELOPMENT
Upstream process development
Downstream process development
Technology transfer & verification
Scale up & down
Process optimization & validation
160RUNS
PATH TO MARKET
PRODUCED OVER 160 cGMP
RUNS IN OVER 15 DIFFERENT
INDICATIONS
1 2
Our development teams can assist
with any challenges you may be facing:
from scale up, to process optimization,
to analyzing and characterizing your
antibody or protein. A broad understanding
of bioprocesses and bioreactor cell
culture enable significant improvements
in recovery rates, stability and actual
protein expression through upstream
and downstream process development
and optimization, all to accelerate the
time to market. Protein characterization
assures safe, stable and efficacious
products providing our Clients with a well
characterized biopharmaceutical product.
COMPREHENSIVE DEVELOPMENT, ANALYTICAL &
MANUFACTURING EXPERTISE ACCELERATES TIME TO MARKET
ANALYTICAL METHODS DEVELOPMENT
Development, feasibility,
optimization, transfer, qualification
& validation of methods
Identity
Purity
Potency
Safety
Characterization
cGMP BIOMANUFACTURING
Multi-product cGMP manufacturing
ICH Q7 compliant facility
Batch, fed-batch & perfusion modes
FDA & EU inspected
VALUE-ADDED SERVICES
Regulatory strategy & submissions
cGMP CMC section 7 support
In-process & release testing
Process & equipment validation
Stability testing
Reference standard
BIOREACTOR CAPACITY
SS SUB
100L 50L300L 200L1000L 1000L
SINGLE USE BIOREACTORSTAINLESS STEEL
3 4 5
Avid’s proven track record of quality and customer service speaks for itself.
Since our inception in 2002, our successful inspection track record continues
to grow, ranging from audits by the U.S. FDA, European agencies, and the State
of California, as well as other regulatory agencies and Clients. This is further
supported by the robust quality systems we have in place and our dedication to
produce high quality products each and every time.
At Avid, we are dedicated to setting the standard in customer service and
exceeding client expectations. Our project management team has extensive
experience collaborating with our Clients and contributing to their success. We
offer a flexible approach to project execution by tailoring each project plan to
the Client’s specific requirements. Throughout the process, project management
acts on behalf of the Client and drives the project internally and externally,
ensuring timelines are met and product is delivered on time.
COMMITTED TO SUPERIOR QUALITY & CUSTOMER SERVICE
TYPICAL PROJECT TIMELINE (MONTHS)
TECH TRANSFER
UPSTREAM
DOWNSTREAM
ANALYTICAL METHODS
MCB GENERATION
TECH TRANSFER
TOX BATCH
GMP RUN
DEVELOPMENT PROJECT
PROCESS TRANSFER PROJECT
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
(CLIENT TO AVID)
(INTERNAL TO PRODUCTION)
AVID BIOSERVICES, INC.
14282 FRANKLIN AVENUE
TUSTIN, CALIFORNIA 92780
USA
PHONE: +1.714.508.6100
WWW.AVIDBIO.COM
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