Your Partner from Concept to Commercial

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
  • Aseptic filling
  • Analytical assay development
  • Method qualification and validation
  • QC release and stability testing
  • Regulatory strategy and submission

Process Sciences

Providing well-characterized biologics

Full Product Lifecycle Capability

Product Lifecycle

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 science

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 2000L.

  • Experience to bring your product to market
    • Producing clinical biologics since 1993
    • Commercial manufacturing since 2004
    • 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

bioreactor-capacity

Expansion to Meet Your Growing Needs

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

The new 40,000-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 modual clean room design
    • Utilizing the latest single-use technologies
    • Designed for late-stage clinical & commercial production
    • Uni-directional process flows for personnel & materials
  • Expanded capacity to meet demand
    • More than doubles current cGMP capacity
    • Built to accomodate up to 2,000L bioreactors
    • Innovative & flexible technologies
  • Flexible & Efficient
    • Multiple single-use bioreactors
    • Downstream processing suites & dedicated support facilities allow for production of a variety of biological products

     

See our new, 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
    timeline

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 15 years of inspection history with no significant impact to the business
      • Successful pre-approval inspections (PAIs) in 2005, 2012 & 2014 and 2015.
      • 2013 and 2015 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. Our role providing in-house manufacturing for a clinical-stage biopharmaceutical company enables us to share firsthand knowledge of the regulatory pathway and provide guidance outside of the realm of a typical CDMO.

Our regulatory team has extensive experience in developing regulatory strategy and approach, drafting responses and assisting in formulating strategies for interactions with regulatory authorities.

We offer a range of services including:
  • Comparability assessments
  • Amendments &Supplements
  • CMC gap analysis
  • IND/BLA/IMPD submissions
  • Assistance with response to FDA questions