FastTrack IND

FastTrack IND

One Roadmap. One Accountable Partner. IND Delivered.

You have a lead candidate. What comes next is the most complex part of the journey — navigating cell line development, upstream and downstream process development, GMP manufacturing, and IND writing across multiple vendors, timelines, and regulatory requirements. FastTrack IND takes full responsibility for that journey, acting as your independent CMC broker from development candidate to IND batch.

Discuss Your IND Programme

One Roadmap. One Accountable Partner. IND Delivered.

You have a lead candidate. What comes next is the most complex part of the journey — navigating cell line development, upstream and downstream process development, GMP manufacturing, and IND writing across multiple vendors, timelines, and regulatory requirements. FastTrack IND takes full responsibility for that journey, acting as your independent CMC broker from development candidate to IND batch.

Discuss Your IND Programme

One Roadmap. One Accountable Partner. IND Delivered.

You have a lead candidate. What comes next is the most complex part of the journey — navigating cell line development, upstream and downstream process development, GMP manufacturing, and IND writing across multiple vendors, timelines, and regulatory requirements. FastTrack IND takes full responsibility for that journey, acting as your independent CMC broker from development candidate to IND batch.

Discuss Your IND Programme

Up to 6

months saved on average

99%

success rate in IND filing

20 -30%

cost reduction vs. standalone contracting

>7 g/L

titer through best-in-class platform selection

What FastTrack IND solves

The Challenge: Navigating the Labyrinth

The path from lead candidate to IND batch involves more than nine key decisions across cell line development, upstream processing, downstream processing, formulation, tox batch manufacturing, fill and finish, IND writing, and regulatory submission. Without an experienced partner managing all of these in parallel, the risks are real: delays, wrong partner selections, misaligned goals, re-design, and re-work — each one adding months and cost.

The FastTrack IND Solution


  • One roadmap — a single, clear CMC plan from sequence to IND

  • One accountable partner — FJBio takes full responsibility

  • Dedicated project manager across all vendors

  • Access to best-in-class CLD platforms and CDMOs, selected independently

  • IND delivered faster and with fewer surprises

What FastTrack IND solves

The Challenge: Navigating the Labyrinth

The path from lead candidate to IND batch involves more than nine key decisions across cell line development, upstream processing, downstream processing, formulation, tox batch manufacturing, fill and finish, IND writing, and regulatory submission. Without an experienced partner managing all of these in parallel, the risks are real: delays, wrong partner selections, misaligned goals, re-design, and re-work — each one adding months and cost.

The FastTrack IND Solution


  • One roadmap — a single, clear CMC plan from sequence to IND

  • One accountable partner — FJBio takes full responsibility

  • Dedicated project manager across all vendors

  • Access to best-in-class CLD platforms and CDMOs, selected independently

  • IND delivered faster and with fewer surprises

What FastTrack IND solves

The Challenge: Navigating the Labyrinth

The path from lead candidate to IND batch involves more than nine key decisions across cell line development, upstream processing, downstream processing, formulation, tox batch manufacturing, fill and finish, IND writing, and regulatory submission. Without an experienced partner managing all of these in parallel, the risks are real: delays, wrong partner selections, misaligned goals, re-design, and re-work — each one adding months and cost.

The FastTrack IND Solution


  • One roadmap — a single, clear CMC plan from sequence to IND

  • One accountable partner — FJBio takes full responsibility

  • Dedicated project manager across all vendors

  • Access to best-in-class CLD platforms and CDMOs, selected independently

  • IND delivered faster and with fewer surprises

Value chain positioning

FastTrack IND operates at the downstream end of the FairJourney Bio value chain — connecting discovery output directly to the clinic.

Explore discovery-to-IND

Explore discovery-to-IND

Independent. Experienced. Fully Accountable

The Service

FastTrack IND acts as an independent broker — not a CDMO, not a CLD provider, but the expert project manager who selects, contracts, and oversees all of them on your behalf. FairJourney Bio's independence means every recommendation is based on what is best for your molecule, not on which partner generates the most revenue.

Independent. Experienced. Fully Accountable

FastTrack IND acts as an independent broker — not a CDMO, not a CLD provider, but the expert project manager who selects, contracts, and oversees all of them on your behalf. FairJourney Bio's independence means every recommendation is based on what is best for your molecule, not on which partner generates the most revenue.

Independent. Experienced. Fully Accountable

The Service

FastTrack IND acts as an independent broker — not a CDMO, not a CLD provider, but the expert project manager who selects, contracts, and oversees all of them on your behalf. FairJourney Bio's independence means every recommendation is based on what is best for your molecule, not on which partner generates the most revenue.

What independence means in practice  

  • No bias toward any cell line development platform or CDMO

  • Recommendations based on open-source, best-fit approach

  • Access to the best technologies at every stage of the CMC journey

  • Full transparency on risks, timelines, and cost impact

  • A partner focused solely on your molecule's success

What independence means in practice  

  • No bias toward any cell line development platform or CDMO

  • Recommendations based on open-source, best-fit approach

  • Access to the best technologies at every stage of the CMC journey

  • Full transparency on risks, timelines, and cost impact

  • A partner focused solely on your molecule's success

What independence means in practice  

  • No bias toward any cell line development platform or CDMO

  • Recommendations based on open-source, best-fit approach

  • Access to the best technologies at every stage of the CMC journey

  • Full transparency on risks, timelines, and cost impact

  • A partner focused solely on your molecule's success

CMC workstreams managed  

  • Gene synthesis

  • Cell Line Development (CLD) — platform selection and execution

  • Upstream Processing (USP)

  • Downstream Processing (DSP)

  • Formulation Development

  • Process and Analytical Method Development

  • Process Transfer to GMP

  • Drug Substance and Drug Product cGMP Manufacturing and Testing

  • Viral Clearance Studies

  • Biosafety Testing

  • Fill and Finish

  • IND Writing and Filing

CMC workstreams managed  

  • Gene synthesis

  • Cell Line Development (CLD) — platform selection and execution

  • Upstream Processing (USP)

  • Downstream Processing (DSP)

  • Formulation Development

  • Process and Analytical Method Development

  • Process Transfer to GMP

  • Drug Substance and Drug Product cGMP Manufacturing and Testing

  • Viral Clearance Studies

  • Biosafety Testing

  • Fill and Finish

  • IND Writing and Filing

CMC workstreams managed  

  • Gene synthesis

  • Cell Line Development (CLD) — platform selection and execution

  • Upstream Processing (USP)

  • Downstream Processing (DSP)

  • Formulation Development

  • Process and Analytical Method Development

  • Process Transfer to GMP

  • Drug Substance and Drug Product cGMP Manufacturing and Testing

  • Viral Clearance Studies

  • Biosafety Testing

  • Fill and Finish

  • IND Writing and Filing

How FJBio manages it

  • Centralised partner management: FJBio holds the MSA with each vendor, not the partner

  • Single invoice: all vendor costs consolidated into one FJBio invoice

  • Pre-negotiated rates: access to volume discounts not available to individual sponsors

  • Dedicated project manager: single point of accountability across all workstreams

  • Proactive forward planning: experienced CMC advisors who anticipate and mitigate common pitfalls

How FJBio manages it

  • Centralised partner management: FJBio holds the MSA with each vendor, not the partner

  • Single invoice: all vendor costs consolidated into one FJBio invoice

  • Pre-negotiated rates: access to volume discounts not available to individual sponsors

  • Dedicated project manager: single point of accountability across all workstreams

  • Proactive forward planning: experienced CMC advisors who anticipate and mitigate common pitfalls

How FJBio manages it

  • Centralised partner management: FJBio holds the MSA with each vendor, not the partner

  • Single invoice: all vendor costs consolidated into one FJBio invoice

  • Pre-negotiated rates: access to volume discounts not available to individual sponsors

  • Dedicated project manager: single point of accountability across all workstreams

  • Proactive forward planning: experienced CMC advisors who anticipate and mitigate common pitfalls

  Principles  

FairJourney Bio takes responsibility to: (i) pre-negotiated competitive pricing, (ii) execute on timelines, (iii) take full responsibility towards IND filing, (iv) maintain cost control.

  Principles  

FairJourney Bio takes responsibility to: (i) pre-negotiated competitive pricing, (ii) execute on timelines, (iii) take full responsibility towards IND filing, (iv) maintain cost control.

  Principles  

FairJourney Bio takes responsibility to: (i) pre-negotiated competitive pricing, (ii) execute on timelines, (iii) take full responsibility towards IND filing, (iv) maintain cost control.

Best Platform. Best Partner. Best Outcome

CLD & CDMO Selection

FairJourney Bio benchmarks all leading CLD platforms and CDMOs based on real project experience and published clinical track records — and uses that knowledge to select the best fit for each molecule.

Best Platform. Best Partner. Best Outcome

FairJourney Bio benchmarks all leading CLD platforms and CDMOs based on real project experience and published clinical track records — and uses that knowledge to select the best fit for each molecule.

Best Platform. Best Partner. Best Outcome

CLD & CDMO Selection

FairJourney Bio benchmarks all leading CLD platforms and CDMOs based on real project experience and published clinical track records — and uses that knowledge to select the best fit for each molecule.

CLD platform benchmarking  


Six major CLD platforms evaluated across key performance parameters:

  • CHO K1 GS-KO + CHOZN® Standard GS: 4–5 g/L typical titer

  • CHO-K1 SURE CHO-M + proprietary SGE vectors: 4–7 g/L

  • CHO DG44 + 4Cell® CLD platform: <10 g/L

  • CHO-K1 miCHO + Leap-In® Transposon: 8–10 g/L

  • CHO-K1 GS-KO + CHOvolution® (ex. Revvity): <10 g/L

  • CHO Edge + Proprietary TnT hyperactive transposase: 8–11 g/L

Note: titer figures are vendor-quoted ranges for standard IgG1 mAbs in fed-batch bioreactor. FairJourney Bio selects based on molecule-specific requirements, not headline titer figures.

CLD platform benchmarking  


Six major CLD platforms evaluated across key performance parameters:

  • CHO K1 GS-KO + CHOZN® Standard GS: 4–5 g/L typical titer

  • CHO-K1 SURE CHO-M + proprietary SGE vectors: 4–7 g/L

  • CHO DG44 + 4Cell® CLD platform: <10 g/L

  • CHO-K1 miCHO + Leap-In® Transposon: 8–10 g/L

  • CHO-K1 GS-KO + CHOvolution® (ex. Revvity): <10 g/L

  • CHO Edge + Proprietary TnT hyperactive transposase: 8–11 g/L

Note: titer figures are vendor-quoted ranges for standard IgG1 mAbs in fed-batch bioreactor. FairJourney Bio selects based on molecule-specific requirements, not headline titer figures.

CLD platform benchmarking  


Six major CLD platforms evaluated across key performance parameters:

  • CHO K1 GS-KO + CHOZN® Standard GS: 4–5 g/L typical titer

  • CHO-K1 SURE CHO-M + proprietary SGE vectors: 4–7 g/L

  • CHO DG44 + 4Cell® CLD platform: <10 g/L

  • CHO-K1 miCHO + Leap-In® Transposon: 8–10 g/L

  • CHO-K1 GS-KO + CHOvolution® (ex. Revvity): <10 g/L

  • CHO Edge + Proprietary TnT hyperactive transposase: 8–11 g/L

Note: titer figures are vendor-quoted ranges for standard IgG1 mAbs in fed-batch bioreactor. FairJourney Bio selects based on molecule-specific requirements, not headline titer figures.

CDMO network — bioreactor scale  


  • 250–1,000 L fed batch and perfusion (SUB and stainless steel)

  • 500–17,000 L fed batch and perfusion (SUB and stainless steel)

  • 1,000–15,000 L fed batch (stainless steel)

  • 2,000 L fed batch, perfusion, N-1 (SUB and stainless steel)

  • 2,000–20,000 L fed batch, perfusion (SUB and stainless steel)

CDMO network — bioreactor scale  


  • 250–1,000 L fed batch and perfusion (SUB and stainless steel)

  • 500–17,000 L fed batch and perfusion (SUB and stainless steel)

  • 1,000–15,000 L fed batch (stainless steel)

  • 2,000 L fed batch, perfusion, N-1 (SUB and stainless steel)

  • 2,000–20,000 L fed batch, perfusion (SUB and stainless steel)

CDMO network — bioreactor scale  


  • 250–1,000 L fed batch and perfusion (SUB and stainless steel)

  • 500–17,000 L fed batch and perfusion (SUB and stainless steel)

  • 1,000–15,000 L fed batch (stainless steel)

  • 2,000 L fed batch, perfusion, N-1 (SUB and stainless steel)

  • 2,000–20,000 L fed batch, perfusion (SUB and stainless steel)

Your CMC journey — key considerations  


Molecule Format & Complexity

Determines CLD strategy, expression characteristics, and developability/manufacturability. FJBio provides access to multiple CLD platforms to best fit molecule characteristics, with early developability and manufacturability assessments.

Process Development Implications

Impacts USP/DSP strategy, upstream productivity, downstream recovery/yield, formulation, and stability. FJBio's integrated USP/DSP team designs one coherent process, with high-throughput scouting runs to select optimal conditions early.

Regulatory / IND Considerations

Drives critical quality attribute strategy, analytical package, and timelines. FJBio provides IND writing support with experience across multiple IND filings.

Your CMC journey — key considerations  


Molecule Format & Complexity

Determines CLD strategy, expression characteristics, and developability/manufacturability. FJBio provides access to multiple CLD platforms to best fit molecule characteristics, with early developability and manufacturability assessments.

Process Development Implications

Impacts USP/DSP strategy, upstream productivity, downstream recovery/yield, formulation, and stability. FJBio's integrated USP/DSP team designs one coherent process, with high-throughput scouting runs to select optimal conditions early.

Regulatory / IND Considerations

Drives critical quality attribute strategy, analytical package, and timelines. FJBio provides IND writing support with experience across multiple IND filings.

Your CMC journey — key considerations  


Molecule Format & Complexity

Determines CLD strategy, expression characteristics, and developability/manufacturability. FJBio provides access to multiple CLD platforms to best fit molecule characteristics, with early developability and manufacturability assessments.

Process Development Implications

Impacts USP/DSP strategy, upstream productivity, downstream recovery/yield, formulation, and stability. FJBio's integrated USP/DSP team designs one coherent process, with high-throughput scouting runs to select optimal conditions early.

Regulatory / IND Considerations

Drives critical quality attribute strategy, analytical package, and timelines. FJBio provides IND writing support with experience across multiple IND filings.

12–14 Months to Your First Clinical Batch

Process & Deliverables

FairJourney Bio's integrated approach seamlessly connects discovery to CMC — with parallel workstream management that eliminates the sequential delays of fragmented vendor management.

12–14 Months to Your First Clinical Batch

FairJourney Bio's integrated approach seamlessly connects discovery to CMC — with parallel workstream management that eliminates the sequential delays of fragmented vendor management.

12–14 Months to Your First Clinical Batch

Process & Deliverables

FairJourney Bio's integrated approach seamlessly connects discovery to CMC — with parallel workstream management that eliminates the sequential delays of fragmented vendor management.

Timeline

12–14 months from development candidate to first clinical batch, with the following workstreams running in parallel under FJBio's integrated project management:

Months 1–2

Molecular optimisation and gene synthesis

Months 1–8

Cell Line Development and Master Cell Bank (MCB)

Months 3–10

Formulation Development

Months 3–10

Process and Analytical Method Development

Months 8–12

Process Transfer to GMP

Months 10–14

Drug Substance and Drug Product cGMP Manufacturing and Testing

Workflow

01

Customer onboarded via MSA

Partner signs a Master Service Agreement with FairJourney Bio — establishing the single contractual relationship for the entire CMC programme.

02

FJBio signs MSA with vendor

FairJourney Bio contracts directly with the selected CLD provider and CDMO partners — the partner has no direct contractual relationship with any vendor.

03

Vendor selection

FairJourney Bio presents the selected vendor recommendation with full rationale — molecule fit, technical capabilities, timeline, and pricing.

04

Vendor invoices FJBio

All vendor costs are invoiced directly to FairJourney Bio.

05

FJBio invoices customer

Partner receives a single consolidated invoice from FairJourney Bio — one invoice, full transparency, no vendor management overhead.

What You Receive

  • Compliant IND package — all documentation required for submission

  • Toxicology batch to required specification

  • Clear manufacturing plan into Phase 1

  • Smooth GMP transfer and defined clinical path

  • Single framework contract with FairJourney Bio

  • Single invoice across all vendors

  • 20–30% cost reduction versus standalone contracting

Fullspectrum Characterization

fullspectrum-characterization

AnyFormat Manufacturing

anyformat-manufacturing

DeepDesign Engineering

deepdesign-engineering

FunctionInsight Assays

functioninsight-assays

B-Cell Navigator

b-cell-navigator

Solutions

solutions

Platforms & Technologies

platforms-technologies

Why FJBio

why-fjbio

Events & Resources

events-resources

Company

company

About

about

Antibody Discovery

antibody-discovery

Protein Production

protein-production

AtomicLevel Cryo-EM

atomic-level-cryo-em

Biologistics

biologistics

Leadership

leadership

Careers

careers

News & Insights

news-insights

Case Studies

case-studies

Fact Sheets

fact-sheets

CellCraft Solutions

cellcraft-solutions

Cryo-EM

cryo-em

Display Platforms

display-platforms

Events

events

Library Diversity

library-diversity

MultiPath Discovery

multipath-discovery

Publications & Posters

publications-posters

Resources

resources

Screening | Analytics | Data Engines

screening-analytics-data-engines

Single B-Cell Screening

single-b-cell-screening

The Antibody Series Conference

the-antibody-series-conference

Tumbler™

tumbler

Webinars

webinars

White papers

whitepapers

Contact Us

contact-us

Download