Full Lifecycle Capabilities—from Concept to Commercial Supply

Avid provides fully integrated Biomanufacturing services for our clients. Each project is unique and we provide customized solutions every step of the way.

  • Cell line optimization
  • Cell culture and purification process development
  • Protein characterization
  • Process optimization, scale-up and validation
  • cGMP clinical and commercial manufacturing
  • Bulk filling
  • Analytical assay development
  • Method qualification and validation
  • QC release and stability testing
  • Regulatory strategy and submission

Process Development

Providing well-characterized biologics

Full Product Lifecycle Capability

Our process sciences group develops the process and analytical methods needed to deliver active products that can readily transfer to cGMP manufacturing. In addition to extensive experience with platform CHO-based IgG expression, the team brings experience gained through project successes in vaccine, recombinant protein, and enzyme process development, providing the expertise you need to advance your program to the next phase.

Process Development


Excellence in process development

We deliver customized expertise to meet your project objectives through all phases of development including:

  • Cell line development
    • Transfection
    • Subcloning
    • Clone selection using ClonePix technology
    • Experience with multiple expression systems
    • R&D material for early downstream development and pre-clinical studies
  • Upstream process development
    • Robust upstream process development using tools such as design-of-experiments (DoE) and quality-by-design (QbD) studies
    • Process optimization and characterization through:
      • Media/feed screening using high throughput process development (HTPD) to increase titer, while maintaining critical quality attributes (CQAs)
      • Spent media analysis to support upstream media feed-screen optimization
      • Transition from traditional stainless steel to stirred tank single-use bioreactors
  • Downstream process development and optimization
    • Antibody-based platform process experience
    • High-throughput (HTP) resins screening (affinity, ion exchange, mix-mode, HIC, etc.)
    • Scale-down model for viral validation
    • Adherence to regulatory and product-quality profiles

Our cell-line, upstream, and downstream development processes combine to ensure you receive a well-characterized biologic with consistent product quality

Analytical Methods


Applying analytical methods to achieve success

Our Analytical Methods Development (AMD) group offers extensive experience in transferring, developing, qualifying, and validating client assays. We tailor our methods to your particular processes and initiate development work at any stage, depending on your needs.

Our AMD team works with you to design an analytical program that will adequately characterize your product to meet regulatory guidelines.

  • Analytical methods development capabilities
    • Standard assays in place to support upstream and downstream development
    • Physiochemical analytical methods development (e.g. SEC, IEX, CE SDS-PAGE)
    • Functional assays (e.g.bioassay, antigen binding using Biacore®)
    • Protein characterization [carbohydrate, peptide mapping, deamidation and oxidation analyses, etc.]

Extensive experience and technical knowledge enable us to troubleshoot challenges throughout the development process, ultimately providing you with a robust and reproducible method.

cGMP Biomanufacturing

Manufacturing Quality From Start to Finish
Scale-up and GMP process conversion

Our Manufacturing Team works closely with Process Sciences, Quality, Supply Chain, and Product Sponsor to successfully transfer processes from Lab-scale to Manufacturing-scale.  Process SMEs (Subject Matter Experts) stay involved throughout the life cycle of the process from development to commercial manufacturing.

Drug substance

Our cGMP facilities in Orange County, California houses manufacturing space dedicated to mammalian cell culture and is able to produce both clinical and commercial biologics. Operating both stainless steel and single use systems, we have flexibility and experience to support a wide array of projects up to 2,000L.

  • Experience to bring your product to market
    • Producing clinical biologics since 1993
    • Commercial manufacturing since 2005
    • Disposable and Hard-piped Chromatography Systems
    • Disposable and Stainless Steel Bioreactors
    • Extensive experience working with various cell lines: CHO, NSO, and hybridoma
    • Produced more than 20 different mAbs for applications including therapeutic mAbs, imaging reagents and antibody intermediates for ADCs
    • Successfully brought products from early development to market

State-of-the-Art Facilities


Flexible Manufacturing Solutions:
  • Both stainless steel and single-use bioreactors
  • Flexible manufacturing scales provide multiple solutions for all project types
  • Disposable components in both upstream and downstream processes
  • Proven cGMP facility with expanding capacity

Bioreactor Capacity


Expansion to Meet Your Growing Needs

Avid expanded its biomanufacturing capacity with the addition of a new state-of- the-art late stage clinical and commercial facility in 2016. Located adjacent to Avid’s headquarters in Orange County, California, this manufacturing facility provides our partners with the resources and expertise to advance their programs from early-stage development through commercial production.

This 42,000-square-foot biomanufacturing facility is outfitted with cutting-edge, single-use equipment to accommodate a fully disposable biomanufacturing process for late Phase III clinical and commercial production of biologics. A range of innovative features are incorporated into the new suite including monolithic modular clean room walls, dedicated support utilities for each key processing area, and the industry’s most advanced single-use production systems. Uni-directional process flows separating personnel and materials provide assurance that the design meets the most stringent regulatory requirements for commercial biologics API manufacturing.

  • State-of-the-Art Facility
    • Innovative & flexible modular clean room design
    • Utilizing the latest single-use technologies
    • Designed for late-stage clinical & commercial production
    • Uni-directional process flows for personnel, materials & product
    • Separate air-handlers for each process area
  • Expanded capacity to meet demand
    • Equipped with 200L, 1,000L & 2,000L single-use bioreactors
    • Innovative & flexible technologies
    • Integrated QC labs for in-process samples, final release & environmental monitoring
  • Flexible & Efficient
    • Multiple single-use bioreactors
    • Downstream processing suites & dedicated support facilities allow for production of a variety of biological products


Take a virtual tour of our Myford State-of-the-Art Facility

Project Management

Driving the success of your program

Our project management team has extensive experience in multiple technical fields, enabling them to drive your project planning and timeline development at every stage. Our areas of expertise include:

  • Process technology transfer
  • Process development
  • Process validation
  • Clinical & commercial supply
Dedicated to Exceeding Your Expectations
Our Commitment to You:
  • Execute each project with the highest quality and integrity standards
  • Provide exceptional customer service
  • Maintain open, honest communications that facilitates a partnership lasting well beyond the project

Our team has an excellent success rate and demonstrated on time release for clinical and commercial batches and develops a timeline to meet your program requirements, providing you with peace of mind in your choice of a CDMO partner.


A passion for customer service

We pride ourselves on setting the standard for customer service. As an Avid client, you will be assigned a dedicated project team that tailors the project strategy and timeline to your specific requirements. Open and honest communication, seamless technology transfer, and easy access to your project management team are just a few of the things you can expect when you partner with us.

Quality Systems

Quality Philosophy

We are collectively responsible for the quality of the products we produce. We deliver on our commitments to provide uncompromised compliance, deliver high-quality products to patients, and achieve the key time-sensitive milestones that drive our clients’ successes.

Quality is our passion and the paramount measure of our success. And it’s our passion for quality that contributes to your success and to the health of your patients.

  • Quality without Compromise
    • We maintain a focused vigilance on ensuring robust, integrated quality systems and compliance with worldwide regulatory agencies.
    • We strive for continuous improvement in our quality systems.
    • We rigorously track our systems’ performance to provide consistent, timely reporting that enables continuous compliance.
    • We are committed to optimal risk management and quality without compromise.
  • Strength in Compliance
    • Our robust quality systems are compliant with U.S. FDA, EU and ROW regulations.
    • Avid has an excellent regulatory inspection history:
      • Over 14 years of inspection history with no significant impact to the business
      • Successful pre-approval inspections (PAIs) in 2005, 2012, 2014, 2015 and 2017 (2).
      • 2013, 2015, 2017 and January 2018 FDA inspections resulting in zero 483 observations.
      • We maintain current registrations and cGMP certificates.

Our focus on quality goes hand in hand with our excellent inspection and compliance history, providing you with peace of mind in your choice of a CDMO partner.

Quality Control

Quality through science and compliance

Our Quality Control (QC) group’s primary focus is to verify the integrity of our processes and products and ensure they meet specifications.

Our Quality Control team verifies process and product excellence through services that include:

  • Quality control that serves your needs

    Our Quality Control team verifies process and product excellence through services that include:

    • Supporting method development projects, transfer and validation of testing methodology used to control raw materials, production intermediates, and final products
    • Performing analytical and microbiological testing at all stages of the manufacturing process, from raw material through final product release
    • Maintaining a robust environmental monitoring program of the manufacturing suite and utilities
    • Performing reference material qualification
    • Providing a full suite of stability services:
      • Real-time stability
      • Accelerated stability
      • Forced degradation
      • Photo stability
      • Freeze/thaw studies
      • Submission-ready reports
      • Trending/shelf life analysis

    Our Quality Control group serves as our internal oversight team, so that you can rest assured that your product is receiving the utmost attention to detail needed to achieve compliance.

Our focus on quality goes hand in hand with our excellent inspection and compliance history, providing you with peace on mind in your choice of a CDMO partner.

Regulatory Affairs

Helping you achieve your goal of commercialization

One of the benefits of partnering with us is our ability to support you from start to finish, including regulatory submissions and support. We offer a range of services including:

  • Comparability assessments
  • Amendments & Supplements
  • IND/BLA/IMPD submissions
  • Assistance with response to FDA questions