Built to Scale Process Development
Robust, scalable biologics process development, from early optimization through CGMP manufacturing, across fed-batch, perfusion, and continuous modes.
Value
Build a Process Ready
for What’s Next
Designed for scalability
Processes are developed with manufacturing in mind, supporting smooth transition from development to CGMP scale.
Aligned across upstream and downstream
Integrated development ensures cell culture and purification strategies work together as a cohesive system.
Built for consistency and control
Data-driven approaches support reproducibility, product quality, and process robustness.
Connected to manufacturing execution
Development outputs transition directly into Avid’s CGMP manufacturing environment.
CONSISTENT PERFORMANCE
Built to Support Every Stage
Scalable process design: Processes are developed to perform consistently from benchtop through manufacturing scale.
Product quality alignment: Critical quality attributes are evaluated and optimized early in development.
Reproducibility: Structured experimentation ensures consistent performance across runs.
Manufacturing readiness: Processes are designed to transition smoothly intoCGMPproduction.
Our Process
From Screening to Stability Data
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01
Understanding and characterization
Rigorous process characterization and DoE methodologies build the regulatory confidence needed from IND through licensure.
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02
From benchtop to CGMP
Integrated development and manufacturing under one roof means efficient scale-up and a well-understood process at every stage.
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03
One process. Built to perform.
At Avid, development is integrated with manufacturing from the start. Every decision contributes to a process that performs at scale.
UPSTREAM
Process Development
Fed-batch: Industry-standard approach optimized for high yield and broad regulatory acceptance.
Perfusion: Continuous culture systems supporting higher productivity and specialized molecule requirements.
Continuous manufacturing: Integrated strategies designed for efficient, next-generation production models.
All upstream programs include media optimization, feed strategy development, seed train design, and bioreactor parameter optimization, supporting performance from early development throughCGMPscale.
DOWNSTREAM
Process Development
Purification built for quality and yield
Chromatography development: Multi-step purification strategies designed to achieve target purity and yield.
Viral clearance & filtration: Robust clearance approaches aligned with regulatory expectations.
UF/DF optimization: Concentration and buffer exchange steps designed for scalability and product stability.
DoE-driven optimization: Systematic evaluation of process parameters to support process understanding and control.
Why Us
Why Avid Bioservices
Fed-Batch, Perfusion, and Continuous
All major upstream modes available and tailored to your program.
Scalable Infrastructure
Development aligned with manufacturing from benchtop toCGMPscale.
Data-Driven Development
DoE-based methodologies supporting process understanding and control.
Integrated with Manufacturing
Direct connection to CGMP clinical and commercial production.
30+ Years of Expertise
Deep experience across biologics modalities and development strategies.
US-Based Operations
Domestic facilities with FDA-experienced quality systems.
Start your process
development program
Tell us about your molecule and goals. We’ll design a process built to perform, from
development through manufacturing.
Learn More
Process Development FAQs
Upstream development focuses on cell culture and protein production, while downstream development focuses on purification and preparation of the biologic drug substance. Both must be developed together to ensure overall process performance.
Fed-batch involves adding nutrients during a culture run and harvesting at the end. Perfusion continuously feeds fresh media and removes product, supporting higher cell density and productivity. Each approach is suited to different molecules and production goals.
Process characterization studies evaluate how process parameters affect product quality. These studies define critical process parameters (CPPs) and support regulatory submissions and validation strategies.
At Avid, process development transitions directly intoCGMPmanufacturing within the same organization, supporting continuity and efficient scale-up.
Design of experiments (DoE) is a statistical approach used to evaluate multiple process variables simultaneously, helping optimize performance and build process understanding.
Yes. Avid supports both new development programs and optimization or scale-up of existing processes.