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

FOR ADDITIONAL INFORMATION PLEASE CONTACT:

BUSINESSDEVELOPMENT@AVIDBIO.COM