What is IND-enabling CMC and why is it important?

IND-enabling CMC (Chemistry, Manufacturing, and Controls) ensures your biologic is safe, consistent, and scalable before clinical trials. It is a critical step to support IND submission and accelerate time to clinic.

What enables the accelerated timeline for ExpressCMC?

ExpressCMC combines process expertise with the ProMax™ vector to generate high-yield, stable clones early, enabling tox DS in ~4 months and GMP DP in ~9 months.

What experience does ProBio have with complex biologics?

Over 50% of projects involve bsAbs, fusion proteins, and fragments, with 40+ IND clearances. ProBio leverages 200+ process solutions to solve complexity challenges.

IND-Enabling CMC Banner - Fast-Track Biologics Development

IND-Enabling CMC Services

A rapid, integrated CMC development platform that accelerates biologics from discovery to IND-ready material with optimized processes. One-stop biologics development and manufacturing in as fast as 4 months from gene synthesis to tox batch.

Overview

Workflow

Case Studies

Related Services

FAQs

Fast-Track IND CMC Development for Antibodies and Proteins

Accelerated Platform

Just 4 months from DNA to clone based tox downstream production
~9 months to GMP drug product
High-yield, stable clone-based production

Built for Complexity

Expertise in bsAbs, fusion proteins, and fragments
Proven in novel modalities
Tailored strategies per molecule
200+ process tools

Analytical Expertise

Advanced potency and bioassay platform
60+ proprietary assay cell lines
Accurate, IND-ready results

Supported Integrated Execution

Senior CMC project team with proven experience in complex biologics
End-to-end development support
Fast, proactive project management

From Gene to Tox DS in as Fast as 4 Months

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Cell Line Development*

Process Development

Formulation Development

Quality Study & Method Qualification

Clone Derived Tox DS Ready

GMP DS MFG & Release

GMP DP MFG & Release

Timeline (Months)
* From DNA to Top 1 clone

ExpressCMC Fast Track to IND

Proprietary ProMax Vector
High-yield, stable expression
mAbs & symmetric bsAbs
DP concentration: ≤50 mg/mL (mAb), ≤30 mg/mL (bsAb)

Speed without compromise: clone-based, not pool-based

Many fast-track workflows rely on cell pools to save time. ProBio goes further, delivering fully characterized clonal cell lines in just 4 months, ensuring robustness, reproducibility, and IND readiness.