Process Development for CORYNEX™ Programs
From strain engineering through analytical development and tech transfer — Aji’s process development team builds the foundation for reliable cGMP manufacturing.
Break the Constraints of Toxicity
E. coli is the default microbial expression system — but it produces lipopolysaccharide (LPS) in every batch. For therapeutic biologics, removing LPS is not optional. It requires dedicated purification steps that add cost, time, and failure risk. Corynebacterium glutamicum produces no LPS. The host organism’s cell wall simply does not contain it. That single difference eliminates an entire class of downstream processing burden — and the regulatory questions that come with it.
Don’t Limit Yourself to the Yields of CHO and Yeast
CHO cell culture is the gold standard for glycosylated full-length antibodies. But for non-glycosylated proteins — VHHs, antibody fragments, antibody mimetics, long peptides — CHO is expensive and slow relative to what a well-optimized microbial system can achieve. CORYNEX™ achieves titers up to 11 g/L. Standard fed-batch fermentation. No proprietary media formulations that lock you in. The same fermentation equipment your CDMO already operates.
Analytical & Quality
In-house analytical capability covers the standard protein characterization suite. CoA issued for every GMP batch. Confirm in-house vs. outsourced for any specific method before committing to clients.
SDS-PAGE / CE-SDS
Assessment of purity, integrity, and apparent molecular weight under reducing and non-reducing conditions
SEC
Assessment of monomer content, aggregates, and other size variants
LC-MS / HRMS
Confirmation of intact mass and product identity, with further characterization as applicable
Binding & Activity Assays
Assessment of binding and biological activity using product-appropriate assays
Bacterial Endotoxin Testing
Quantification of bacterial endotoxin to support product quality and release testing
Stability Studies
Long-term and accelerated stability studies designed to support product development
End-to-End Process Development
Every CORYNEX™ program begins with process development — strain, upstream, downstream, analytics, and tech transfer — before a single cGMP batch is manufactured.
Production Strain Engineering
Engineering and optimization of the C. glutamicum production strain: gene insertion, promoter selection, secretion signal optimization, and screening for titer and purity. Our team has built the CORYNEX™ strain library over decades of industrial development.
Fermentation Process Development
Media optimization, fed-batch strategy, and fermentation parameter development from 1L scale through pilot bioreactor. Scale-up strategy aligned with the target GMP facility’s equipment.
Purification Process Development
Harvest and primary recovery, chromatography process development (capture, intermediate, polishing), UF/DF, formulation development. Designed around CORYNEX™’s simplified secretion baseline — fewer steps, lower cost.
Analytical Method Development
Identity, purity, potency, and safety analytical methods developed. In-house analytical capability covers the standard protein characterization suite.
Technology Transfer to GMP
Full process package preparation: process descriptions, batch record templates, risk assessments, analytical method transfer packages. Transfer executed to an Aji Bio-Pharma partner CDMO, or client-nominated partner CDMO.
CMC Documentation Support
Process development data packages for IND CMC filings — confirm exact scope of CMC documentation support.
Let’s discuss CORYNEX™ for your protein program
Endotoxin-free. High-yield. Simplified purification. One team from strain development through cGMP.