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Services

Biosimilar
development services

100+ OTS pools

10 OTS clones

7+ g/L Pool titers

50L Scale in-house

Value drivers

A different approach to productivity and quality — with fewer steps and less risk

Biosimilar development isn’t a discovery problem – it’s a matching problem. The program is won or lost on titer economics, CQA control, and process continuity.

Three places programs typically fail:

  1. Titer at Acceptable Cost

    The economics problem

    • Biosimilar margins are thin – sub-4 g/L titers make scale-up painful
    • Legacy CHO platforms weren’t built with biosimilar cost structures in mind
    • COGS at commercial scale is set in cell-line development, not after

  2. Limited CQA Control

    The comparability problem

    • Product quality must match the innovator profile
    • Glycosylation and charge variants require active process control
    • Late CQA drift creates rework and delays

  3. Vendor Handoff Drift

    The continuity problem

    • Each handoff introduces process and documentation variability
    • Disconnected CLD and process development increase comparability risk
    • Continuity matters from cell line through scale-up

How We Solve It

The three pillars
of Celltheon biosimilars

Celltheon’s biosimilar offering rests on three engineered advantages – every program runs on the same stack.

  1. Pillar 1

    High-Titer, Cost-Effective Expression

    • GOLDILOCKS™ + ELIXIR™ deliver 14+ g/L pool titers
    • 7-14 g/L clone titers across every modality
    • Royalty-free for biosimilar programs – always
    • Higher titer = lower COGS at commercial scale
    • One co-optimized stack, no per-program tuning
  2. Pillar 2

    ELIXIR™ for Tunable Product Quality

    • Media + feed formulations engineered for CQA control
    • Glycosylation tunable: afucosylation, sialylation, galactosylation + mannosylation control
    • Track aggregation + charge variants throughout PD
    • Perform QA matching within weeks of project initiation
  3. Pillar 3

    In-House Process Development to 50L

    • Full upstream + downstream PD under one roof
    • No vendor handoffs = no comparability drift
    • 50L non-GMP scale-up validates before commercial
    • Analytical characterization at every stage
    • Tech transfer package handed to your CDMO

Engagement Models

Two paths to Biosimilar development

Pick your starting point. License pre-developed material from our OTS library or build a custom program from sequence against your reference molecule

  • 100+ molecules
    Path A – OTS library

    License from the OTS Biosimilar Library

    Pre-developed cell lines and material against leading reference biologics. Pick up where we left off and advance to CB and scale-up on accelerated timelines.

    • 10 biosimilars with developed clones
    • 100+ biosimilars with developed stable pools
    • Rapid access to innovator for comparability studies
    • Skip the CLD front-end – go directly to scale-up

    Ideal for: major reference biologics; speed-to-IND plays

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  • Path B – custom development

    Build from Sequence Against Your Reference

    Full GOLDILOCKS-based development for your reference molecule. Structured as four packages – pick the stage you need.

    • Royalty-free cell line license, end-to-end
    • Four engagement packages: Pool / +Clone, USP / +DSPD / 50L
    • Tunable QA control via ELIXIR™ media strategy
    • Delivered to RCB; client scales to 2,000L+ commercial

    Ideal for: programs targeting newer references not in the OTS library

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Cell culture dishes in a laboratory Cell culture dishes in a laboratory

Package options

Two biosimilar development paths — license ready OTS material or build a custom program from sequence

All packages include comprehensive data reports suitable for regulatory submissions. A la carte and custom configurations are available.

  • Package 1

    Pool Evaluation

    • Timeline: ~1 month

    Starting point – proves the molecule

    • Gene synth + clone (pGL™)
    • GOLDILOCKS™ → SUPERCELL™
    • Pool + fed-batch CQA panel
    • Pool preserved in LN₂

    Use for: early proof of concept, go/no-go decisions

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  • Package 2

    Clone + Upstream Process

    • Timeline: ~2.5 months

    Includes Package 1, plus:

    • VIPS® subcloning (ICH Q5D)
    • 300-clone ProA BLI screen
    • Top-5 RCB + USP DoE
    • Locked USP conditions

    Use for: characterized lead clone + optimized USP

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  • Package 3

    Stability + 3L + DSP

    • Timeline: ~4.5 months

    Includes Package 2, plus:

    • 60-gen stability + NGS
    • 3L bioreactor scale-up
    • Full DSP (8 unit ops)
    • Locked DSP at 3L scale

    Use for: tech transfer at CDMO without 50L

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  • Package 4

    Full 50L USP / DSP

    • Timeline: ~6 months

    Includes Package 3, plus:

    • 50L non-GMP USP + DSP
    • DS at target conc. + COA
    • Tech transfer pkg (full)
    • RCB shipment to CDMO

    Use for: de-risked scale-up + DS for IND work

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Available When You Need It

Comparability analytics

Analytical methods we can apply for innovator comparability work, when the program calls for it. Offered as an add-on to any service package.

Attribute Method
Primary structure Intact + reduced (deglycosylated) mass by RP-LC-MS, disulfide mapping by LC-MS
Charge variants icIEF + CEX-HPLC (orthogonal)
N-glycan profile HILIC-HPLC, peptide mapping by LC-MS
Aggregation / purity SE-HPLC, DLS, HIAC
Post-translational modifications Peptide mapping by LC-MS/MS
Fragmentation CE-SDS reduced + non-reduced
Potency BLI/SPR affinity, ELISA potency, Cell-based bioassay vs innovator reference
Residual impurities HCP ELISA, hcDNA qPCR, residual Protein A ELISA

Comparability characterization is offered as an add-on to any package. We can also tune the upstream process via ELIXIR™ media/feed strategy to shift QAs toward an innovator target profile

Bonus Capability for Any Program

6,000+ innovator
sequence database

Internal Database

6,000+

clinical protein sequences

Use Cases

Express any sequence at multi-gram scale as a control protein in ~3 weeks via OmniCHO™ transient expression:

  • Innovator control material for comparison studies
  • Reference standard for analytical method development
  • Pre-IND comparability characterization
  • Applicable to biosimilar and nonbiosimilar development
Frequently Asked Questions

Quick answers
to common questions

Quick answers about SUPERCELL™.

View more answers

Discuss your molecule with our scientists

We don’t workaround — we innovate
and deliver

Explore whether OmniCHO™ is the right expression platform for your specific protein format.

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