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Drug substance
process development

PD on pool material. Lock the
process before the clone.

  • ~7 months
    seg to 50L
  • 8 unit-op
    DSP train
  • 50L non-GMP
    in-house
  • Tech transfer
    package included

Program delays

Why standard PD programs lose 3–6 months — and how an integrated workflow keeps development moving

Traditional PD programs often move step by step across separate teams, which creates handoff delays, repeated work, and slower decisions.

Celltheon’s integrated approach keeps expression, purification, characterization, and optimization connected — helping teams move faster with fewer workflow gaps.

  1. Linear Module Execution

    The serial-workflow problem

    • Each module waits for the prior to finish
    • CLD → analytics → USP → DSP → 50L = ~12 mo
    • Idle weeks pile up between handoffs

  2. Vendor Handoffs

    The continuity problem

    • CLD at one group, PD at another, scaleup at a third
    • Each handoff adds time + cost + CQA drift
    • Comparability gets harder at every stage

  3. Re-Optimization at Scale

    The scale-up problem

    • Process on clone needs re-work at 50l
    • Vendors discover this after material is made
    • Add 2-3 months of unplanned dev

Three pillars

The Celltheon
PD advantage

Three structural advantages let us deliver a complete 50L process in ~6 months – significantly faster than typical CDMO timelines for the same

  1. Pillar 1

    In-silico liability screen

    • PD modules run in parallel, not series
    • DSP starts on pool material, not RB material
    • 10L WAVE pool harvest feeds DSP
      at Month 2
    • Subcloning + USP DoE run concurrently
    • Sequence to 50L DS in ~6 months
  2. Pillar 2

    Integrated With CLD + Analytics

    • Same team for CLD, PD, analytics, and 50L
    • No vendor handoffs = no COA drift
    • Analytics tied to the platform that made the molecule
    • Single tech transfer at program end
    • One contract, one timeline, one team
  3. Pillar 3

    Up to 50L Non- GMP In-House

    • 50L single-use bioreactor for scale validation
    • Full 8-unit-op DSP train at 50L
    • Process integration batches with hold studies
    • DS release per qualified analytical methods
    • Tech transfer package ready for your CDMO

The Integrated PD workflow

Six PD phases overlap on a single timeline. DSP development starts on stable-pool material before the final clone is selected – compressing the critical path by months.

  1. MONTH 1-4

    PHASE 1 – CLD

    • Pool dev + 10L WAVE harvest
    • 300-clone screen → top-5 RCB
    • 60-gen stability + NGS
  2. MONTH 1.5-3.5

    PHASE 2 – Analytics

    • Platform method qualification
    • Transfer to receiving site
    • Fit-for-purpose dev
  3. MONTH 2-4.5

    PHASE 3 – Upstream PD

    • 24-flask shake DoE
    • 4 x 3L on pool RCB
    • 4 × 3L on final clone RCB
  4. MONTH 2.5-4.5

    PHASE 4 – Downstream PD

    • 8 unit operations developed
    • On 10L WAVE pool material
    • 3L DSP adaptation batch
  5. MONTH 4.5-5.5

    PHASE 5 – Integration

    • 2 × 3L integration batches
    • Full hold time studies
    • Process + spec lock
  6. MONTH 5.5-7.5

    PHASE 6 – Tech T× + 50L

    • 1-month tech transfer
    • 50L non-GMP batch
    • DS Certificate of Analysis

The 8 DSP unit operations

Eight-unit-operation DSP train developed in-house for standard mAb and Fc-containing biologics. Adapted unit ops for non-Protein-A targets, custom polishing for bispecifics).

  1. Clarification

    Depth filter sizing studies. Primary + secondary trains scalable to 50L.

  2. Protein A

    DBC + elution optimization on ProA. Yield + HCP clearance.

  3. Low-pH VI

    pH 3.5 hold + hold-time optimization. Recovery into AEX load buffer.

  4. Depth Filtration

    Sizing on neutralized Pro eluate. Filter train selection for scalability.

  5. AEX/CEX Polishing

    Flow-through mode for HCP + cDNA clearance. Targets <10 ng/mg HCP, <10 pg/mg hcDNA.

  6. Nanofiltration

    Filter sizing for viral clearance. Capacity assessment and train selection.

  7. UF/DF

    Concentration + buffer exchange into formulation buffer at target DS concentration.

  8. Final Filtration

    0.22 um bioburden-reduction filtration of formulated DS. Locked- process adaptation batch.

Scientists discussing experimental results on a tablet in the laboratory Scientists discussing experimental results on a tablet in the laboratory
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