AtaGenix Laboratories

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Scale-Up

AtaGenix provides large-scale antibody and protein production from milligram pilot runs to multi-gram manufacturing batches — using CHO-K1, XtenCHO™, and HEK293 mammalian platforms with bioreactor capacity up to 200 L.

200 L

Bioreactor Capacity

2–4 wks

Transient Turnaround

>95%

Purity (SDS-PAGE)

10 g+

Max Delivery Scale

Case Highlight — Mouse IgG2a produced via transient CHO at 200 L scale: 288 mg/L yield, 1.97 g total delivery, SDS-PAGE >95%, SEC-HPLC >99% monomer, 4-week turnaround from DNA to shipped product.

Supported Formats

Format Species / Variants
Full-length IgG Mouse, rabbit, human, camelid — all subclasses
Antibody fragments Fab, scFv, VHH / nanobody
Bispecific formats CrossMAb, BiTE, IgG-scFv, DVD-Ig
Fc-fusion & scaffolds Receptor-Fc, enzyme-Fc, therapeutic scaffolds

Transient or Stable — Your Call

Need material next month? Transient CHO/HEK gets you there. Need consistent supply for 12+ months? We build a clonal cell line with documented stability and regulatory-ready process records. Same QC pipeline either way.

One Vendor, Every Format

IgG, nanobody, bispecific, Fc-fusion — we handle format-specific vector design, expression optimization, and purification in-house. No subcontracting, no finger-pointing when timelines slip.

Ship-Ready, Worldwide

Every batch ships with lot-specific CoA, cold-chain packaging, and export documentation. Add SPR/BLI kinetics, FACS, neutralization assays, lyophilization, or custom aliquoting as needed.

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AtaGenix's scale-up platform bridges discovery and manufacturing. Transient CHO/HEK293 expression delivers up to 200 L batches in 2–4 weeks for rapid in vivo material supply. For projects requiring lot-to-lot consistency and regulatory documentation, stable cell pool or clonal cell line production provides gram-scale output with defined process parameters. Both routes share the same downstream pipeline: Protein A/G or Ni-NTA affinity capture, SEC polishing, endotoxin removal, and a comprehensive QC package (SDS-PAGE, SEC-HPLC, BCA, LAL, CoA).

Scale-Up Production Workflow

A standardized 4-stage pipeline from gene sequence to gram-scale purified antibody with QC at every checkpoint.

01

Gene & Vector

Codon optimization
Vector design
Plasmid amplification

02

Pilot Expression

Small-scale transfection
Titer verification
Quality pre-check

03

Scale-Up Production

Up to 200 L transient
or stable pool fermentation
Fed-batch optimization

04

Purification & QC

Protein A/G + SEC
Endotoxin removal
SDS-PAGE, SEC-HPLC, CoA

Service Scope

 Transient CHO / HEK293 (up to 200 L)  Stable cell pool or clonal cell line production
 Full-length IgG, Fab, scFv, VHH, bispecifics  Fc-fusion proteins and therapeutic scaffolds
 Protein A/G + SEC polishing purification  Endotoxin removal (<0.1 EU/mg)
 Full QC: SDS-PAGE, SEC-HPLC, BCA, endotoxin  Optional: SPR/BLI binding, FACS, neutralization
 Buffer exchange, lyophilization, custom aliquoting  Cold-chain global shipping with export documentation

Production Route Comparison

Two routes, same QC standards. Pick based on timeline and lot consistency requirements.

Factor Transient (CHO/HEK) Stable Pool / Cell Line
Timeline 2–4 weeks 8–16 weeks
Typical Scale 10 mg – 2 g 1 g – 10 g+
Lot Consistency Batch-to-batch variation High consistency (clonal)
Regulatory Path Research / preclinical IND-enabling, CMC-ready
Best For In vivo studies, lead characterization Kit production, clinical supply, CMO transfer

Starting smaller? Explore our CHO Transient or HEK293 Transient for milligram-scale feasibility, then scale up when your lead is confirmed. Or go directly to a CHO Stable Cell Line for long-term manufacturing-ready supply.

Frequently Asked Questions

What is the maximum production scale AtaGenix can support?

Our current bioreactor capacity supports transient expression up to 200 L per batch. For projects requiring larger volumes, we run multiple batches in parallel or transition to stable cell pool production for consistent multi-gram supply. Typical single-batch yields range from 10 mg to 2 g (transient) or 1–10 g+ (stable pool/cell line).

When should I choose transient vs. stable pool production?

Choose transient when speed is the priority — 2–4 weeks from DNA to purified antibody, ideal for in vivo studies and lead characterization. Choose stable pool or clonal cell line when you need lot-to-lot consistency, regulatory documentation, or repeated production campaigns over months to years.

What antibody formats can be produced at scale?

We support full-length IgG (all subclasses, mouse/rabbit/human/camelid), Fab, scFv, VHH/nanobody, bispecific formats (CrossMAb, BiTE, IgG-scFv), and Fc-fusion proteins. Each format follows an optimized expression and purification workflow tailored to its specific requirements.

What QC data is provided with each batch?

Every batch ships with a lot-specific Certificate of Analysis (CoA) including SDS-PAGE (reducing + non-reducing), SEC-HPLC (monomer/aggregate profile), endotoxin (LAL assay, <0.1 EU/mg standard), and protein concentration (BCA or A280). Optional add-ons include SPR/BLI binding kinetics, FACS, neutralization assays, and stability studies.

Timelines and yields depend on antibody format, expression system, and production scale. Quote-based pricing. GMP-grade scope available upon request.

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