Done Right From DNA to IND
Integrated biologics development from gene sequence to IND-enablingCGMPbatch, one team, one program, fully US-based.
Value
Move to IND with
Clarity and Momentum
Faster path to IND
Parallel development workstreams keep your program advancing, accelerating timelines while maintaining the quality and rigor required for IND submission.
Built for scale from day one
Cell lines, processes, and analytical methods are designed with future manufacturing in mind, so your program is ready for what comes next.
Stronger CMC foundation
Every dataset and document is developed with IND submission requirements in mind from the beginning.
Aligned, integrated execution
One team working across all phases ensures continuity, shared understanding, and
consistent decision-making.
PROGRAM
Set Your Program Up
for What’s Next
The path to IND is where the foundation of your program is built. Early development decisions shape manufacturing scalability, regulatory readiness, and clinical timelines.
With an integrated approach, each phase builds on the last, creating a cohesive program that moves forward with confidence. Avid ensures every decision supports the full development pathway, from gene sequence through clinical manufacturing and beyond.
HOW
Built for Progress
and Predictability
Speed to IND: Coordinated, parallel workflows keep your program moving efficiently.
Program alignment: A single team ensures continuity across all development stages.
Regulatory readiness: Data and documentation are structured for IND submission from day one.
Efficient execution: Integrated development supports smooth progression without unnecessary rework.
Our Process
From Gene to CGMP Batch
-
01
Cell Line Development
Stable, high-producing CHO or HEK293 cell lines with IND-ready documentation,
including RCB and MCB generation. -
02
Process Development
Scalable upstream and downstream processes designed for efficient transfer into GMP
manufacturing. -
03
Analytical Development
Robust analytical methods supporting characterization, release testing, and regulatory
submission. -
04
Formulation Development
Stability-focused formulations aligned with real-world storage and use conditions.
-
05
IND-Enabling CGMP Batch
CGMP manufacturing, release testing, and stability initiation supporting the IND CMC package.
SOLUTION
One Program.
Fully Aligned.
Avid’s DNA to IND solution brings together every CMC development function under one team, in one location, under one quality system.
Cell line development, process development, analytical development, formulation, andCGMPmanufacturing are executed as a continuous program, not disconnected phases. This approach supports consistency, accelerates timelines, and simplifies the path to IND.
APPROACHES
Built Around Your Program
Fully Integrated Program: End-to-end DNA to IND execution under one contract, one team, and unified project management, supporting speed and alignment across all phases.
Modular Engagement: Start at any stage and expand as needed. Engage individual services or build toward a fully integrated program over time.
Why Us
Why Avid Bioservices
One Team, Start to IND
Continuity across every phase of development.
Parallel Execution
Coordinated workstreams designed to support efficient timelines.
Built for IND Submission
Data and documentation aligned from the beginning.
Deep Biologics Expertise
30+ years of development and manufacturing experience.
Fully US-Based
Domestic operations with FDA-experienced quality systems.
Start your path to IND
Tell us where you are in development. We’ll help you move forward with clarity, speed,
and confidence.
Learn More
DNA to IND FAQs
US-based development supports streamlined communication, alignment with FDA expectations, and reduced logistical complexity.
A typical DNA to IND program takes approximately 12–18 months, depending on molecule complexity, expression system, and development scope. Integrated programs with parallel workstreams can support more efficient timelines.
The CMC section of an IND submission includes details on the manufacturing process, analytical characterization, stability data, cell bank information, and release testing from the IND-enablingCGMPbatch.
A single CDMO supports continuity across development stages, allowing teams to build on shared knowledge and aligned processes. This integrated approach simplifies coordination, supports efficient timelines, and produces a consistent regulatory package.
An IND-enablingCGMPbatch is the first drug substance manufactured under CGMP conditions to support regulatory submission. It provides the release, stability, and manufacturing data required for the IND application.
Yes. Avid supports programs from early development through clinical and commercial manufacturing, allowing for continuity of team, process, and quality systems without the need for tech transfer.