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PepCellerate™ First-In-Human (FIH) Clinical Trial Supply

Your Fast Path to First‑in‑Human Peptide Injectable Clinical Trials

Accelerate Your Peptide Therapeutic into Clinical Phase 1 with integrated CMC development services.

  • Shortened timelines: ~11 months from sequence to First‑in‑Human clinical trials
  • Parallel peptide API and injectable drug product workflows between teams
  • Proven regulatory track record to support FIH peptide IND/CTA filings
  • Reduced Risk with phase-appropriate GMP infrastructure and fewer handovers
Talk to our Peptide-Injectable Experts
Our PepCellerate™ Approach

Our Peptide First-In-Human Approach

Aligned CMC Development Pathways Speed Up Your Peptide-Injectable Clinical Trials

The timelines of ~11 months apply for linear, branched or cyclic peptides up to approximately 40 – 45 amino acids and with a batch size range of 50 – 600 g.

 

Reaching Phase 1 CMC readiness typically takes 12 – 18 months, including tox studies, depending on the complexity of the peptide.

With PepCellerate™, CordenPharma offers a game-changing solution that seamlessly integrates peptide to injectable development and manufacturing to significantly reduce timelines to less than one year, accelerating peptide therapeutics into First-in-Human (FIH) studies.

 

How Do We Do It?

 

By aligning the development of peptide drug substance (API) and injectable drug products under one global facility network, supported by our expert project management and regulatory teams from day one. As your single accountable partner, we bring decades of peptide-injectable development and manufacturing expertise to help eliminate fragmented supply chains and anticipate key decisions so your team can stay focused on science and clinical strategy without vendor coordination.

Built for lean biotech teams with fastmoving pipelines, PepCellerate™ minimizes handovers, reduces risk and shortens time-to-clinic through parallel development pathways and seamless transitions from API to finished clinical material.

The result: clear ownership, predictable timelines, and IND / IMPD ready CMC packages, right the first time.

Your Benefits

Why Choose PepCellerate™?

Reach your proof-of-concept sooner and strengthen your peptide program’s value, competitiveness, and funding potential.

Speed to Clinic - Accelerated IND Readiness

Integrated workflows with parallel peptide API and injectable Drug Product development to help you initiate tox studies earlier and enter phase I within ~11 months.

One Partner, One Program

End-to-end peptide expertise, from synthesis to injectable fill-finish, reduces coordination effort, rework, and supply chain complexity (one MSA and one quality agreement for both Drug Substance & Drug Product).

Highest Priority Means Efficiency in Cost & Planning

One integrated partner means fewer vendors, lower logistic complexity, and improved forecasting across Drug Substance (API) and Drug Product. Even if the API delivery shifts, your timeline stays intact from guaranteed drug product manufacturing slots with no additional costs.

Quality & Regulatory Confidence

Phase‑appropriate GMP infrastructure and a proven track record in supporting FIH peptide IND/CTA filings globally – a strong foundation for future submissions, without costly rework later.

Flexibility & Scalability

Proven experience across diverse peptide modalities with smooth API scale-up from milligrams to multikilogram quantities and multiple injectable development lines across various formats, including aseptic fill and finish of Pre-Filled Syringes (PFS), vials and cartridges.

Packaging & Logistics

Comprehensive injectable clinical trial packaging services (primary & secondary) and shipment handling worldwide.

Learn More from Our Commercial Business Unit Heads

Peptide-Injectable First-In-Human Capabilities

PepCellerate™ Development Capabilities

Peptide Drug Substance

Our Frankfurt (DE) Peptide Centre of Excellence provides end-to-end IND/CMC support for peptide programs from early development through clinical supply. Core capabilities include:

  • Solid-Phase Peptide Synthesis (SPPS) process development and optimization with Tech Transfer directly into large-scale cGMP manufacturing
  • Non-GMP and GMP-certified Phase I/II clinical trial peptide manufacture from mg up to single digit kg scale batch size
  • Phase-appropriate process development, balancing delivery speed with scalability and robustness
  • Expertise in route scouting, impurity control and analytical method development
  • Advanced peptide conjugation capabilities with various moieties
  • Transparent project management with Smartsheets

The site is fully integrated within our global facility network to supply seamless scale-up and late-stage manufacturing of commercial peptide drug substance, injectable fill and finish and oral peptide drug products.

Injectable Drug Product

 

Our CordenPharma Caponago (IT) injectable development lab provides state-of-the-art development technologies and a team of >50 dedicated scientists to bring your peptide injectable projects to manufacturing readiness. Core capabilities include:

  • Newly updated 600 sqm development lab designed to accelerate your peptide clinical trial into CMC readiness.
  • Wide experience with various complex modalities including Peptides, Oligonucleotides, Monoclonal Antibodies (mAbs), Biologics, Lipid Nanoparticles (LNPs) and Small Molecules.
  • Internal transfer, development, optimization and validation of advanced analytical methods.
  • Comprehensive product characterization to define the critical attributes of complex molecules and formulations.
  • Process development to ensure manufacturing scalability and robustness.
  • QC testing for clinical drug products, ensuring that every batch meets the highest standards of safety and compliance.

As your project progresses through successive clinical phases, the facility is fully equipped to seamlessly transition from early development to late-stage manufacturing, ensuring continuity, efficiency and regulatory alignment at every step. Our flexible capabilities support a broad range of sterile drug product presentations, including both liquid and lyophilized formats across varying batch sizes and scales.

Clinical Trial Packaging

Our dedicated area for Clinical Trial Packaging in CordenPharma Caponago (IT) offers labeling, kit management, and distribution support, ensuring your investigational products reach the site on time and according to your unique trial requirements. Core capabilities include:

  • Versatile Configurations: Offering both individual and multi-pack configurations for vials, PFS, ampoules, and cartridges. This flexibility ensures your products are packaged exactly as needed for your clinical trials.
  • Scalable options: Manual packaging for early clinical trials with multiple fully automated options for phase III and commercial.

Explore the Capabilities and Facilities that Power PepCellerate™

CordenPharma Peptide Platform Brochure: deep expertise in proven peptide production.

CordenPharma Injectable Platform Brochure: robust sterile injectable capabilities.

CordenPharma Frankfurt Peptide Centre of Excellence Fact Sheet: Small to mid-sized GMP clinical peptide development facility.

Capanago Facility Fact Sheet: Sterile injectable manufacturing with flexible formats.

CordenPharma White Paper: Choosing the Right Sterile Injectable Manufacturing CDMO

Packaging Brochure: Drug Product packaging formats and capabilities.

Downloads

Talk to our PepCellerate™ Experts

FAQs

PepCellerate™ Frequently Asked Questions

Analytical: What analytical methods are used in PepCellerate™ for drug substance and drug product?

As soon as initial peptide drug substance development material is available, the drug substance and drug product site teams work together on the development of a phase-appropriate analytical method for the release of all material, including the tox materials. If In Process Controls (IPCs) are needed for the drug substance, either the phase appropriate release method will be applied, or platform methods will be used.

What is the typical complexity of a peptide sequence for PepCellerate™?

The timelines of ~11 months apply for linear, branched or cyclic peptides up to approximately 40 – 45 amino acids. While longer or more complex peptides (e.g. conjugates, bicyclic structures) will be manufactured with the same CordenPharma early-phase development approach and by the same agile manufacturing team, the additional manufacturing steps required may result in slightly longer timelines.

What is the typical batch size of the Tox and GMP material that are manufactured within this program?

In our early-phase development and manufacturing site in Frankfurt (Germany) we have fully automated GMP production equipment trains with SPPS synthesizer volumes up to 100 L. The material demand depends on the dose strength and molecular weight of the peptide, but the typical range of drug substance demand for Phase I is within 50 – 600 g, which is well covered . If required, the batch size can go up to 1500 g.

Does CordenPharma have oral solid peptide dosage forms, and what timelines apply there?

For oral peptide drug substance development and manufacturing at our Frankfurt site, the same timelines apply for quantities up to 1500 g. Our site in Plankstadt (Germany) specializes in the formulation development of oral solid peptide delivery dosage forms.

Depending on the complexity of the formulation, the timelines for oral peptides may deviate from those indicated for injectables. But in this case as well, our drug substance and drug products teams work together to bring your peptide therapeutic to Phase I clinical trials as fast as possible.

Do you support both clinical and commercial aseptic manufacturing?

Yes. CordenPharma offers fully integrated end-to-end peptide drug substance to injectable drug product CDMO support.

Our facility in Caponago provides flexible sterile injectable capacity for clinical trials (Phase I-III) with small-scale batches, as well as high-volume commercial manufacturing with an annual capacity exceeding 200 million units. We ensure seamless tech transfer as your program scales.

In addition to peptides, what other types of complex modalities and drug products do you manufacture?

We specialize in the aseptic fill & finish of complex, high-value modalities. This includes Peptides, Oligonucleotides, Small Molecules, Monoclonal Antibodies (mAbs), Biologics, Lipid Nanoparticles (LNPs) for mRNA vaccines, and other Injectables. We handle liquid and lyophilized formulations in vials, Pre-Filled Syringes (PFS), and cartridges.

What is the difference between clinical phase 0 and clinical phase 1?

Clinical Phase 0 and Clinical Phase 1 differ primarily in dose, objectives, and development intent for peptide injectables.

Phase 0 studies are optional, early exploratory trials that administer microdoses of a peptide injectable to a small number of subjects to confirm human pharmacokinetics or target engagement, without evaluating safety or efficacy.

In contrast, Phase 1 is the true first‑in‑human clinical stage, using therapeutically relevant doses to assess safety, tolerability, pharmacokinetics, and local/systemic effects of the peptide injectable formulation, and to establish a safe dose range for further clinical development.

What does it mean to reach First-In-Human readiness?

Reaching peptide injectable First‑In‑Human (FIH) readiness means the drug product is fully prepared for initial dosing in humans under regulatory approval.

This includes having a GMP‑manufactured peptide API and injectable formulation, validated analytical methods, and a stable drug product suitable for the intended route of administration. FIH readiness also requires a completed IND‑enabling package, including nonclinical safety data, dosing justification, and CMC documentation demonstrating product quality, sterility, and consistency to support safe first‑in‑human clinical trials.

Will you be at Tides US 2026 in Boston?

Join our speaker presentation on May 13 at 12:20

 

“Accelerate timeline to start PhI: Phase appropriate development and integrated drug product supply”

 

by Tobias Kapp, Global Head of Peptide Development
Join the session

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Ready to Speed Up Your Phase 1 Clinical Trial?

Contact us to schedule a CMC strategy call and map your fastest route to peptide-injectable IND / IMPD readiness.

Dr. Mimoun Ayoub

Sr. VP, Global Commercial Head - Peptides & Oligonucleotides