At Ceyone Life Sciences, we provide phase-appropriate development and manufacturing strategies that align with the unique requirements of each stage of drug development. By adhering to stringent quality standards and leveraging our versatile manufacturing capabilities, we ensure a reliable, compliant, and timely supply of drug substances (APIs) from pre-clinical toxicology studies through to First-in-Human (FIH) clinical trials.
- From Discovery Chemistry to Early Clinical Supplies
- Rapid synthesis to bridge candidate nomination and early clinical trials
- Transition discovery molecules into phase-appropriate drug substances
- Mitigate scale-up risks through early chemical and safety evaluations
- Pre-Clinical & Toxicology Batch Supplies
- Gram to multi-kilogram non-GLP synthesis for DMPK and safety pharmacology
- GLP-compliant toxicology batch manufacturing
- Rapid synthetic route scouting and proof-of-concept supply
- Specialty and niche chemical intermediates
- Phase 1 / FIH cGMP API Manufacturing
- Early-phase cGMP drug substance manufacturing under ICH Q7 guidelines
- Cleanroom and pilot-scale batch production
- Batch sizes ranging from hundreds of grams to tens of kilograms
- Phase-Appropriate Analytical & Stability Support
- Early analytical method development and optimization (HPLC, GC, LC-MS)
- Phase 1 batch release testing and Certificate of Analysis (CoA) generation
- ICH stability studies (real-time and accelerated) to define clinical retest dates
- Process safety evaluation and thermal hazard screening (DSC/reaction safety)
- End-to-End Early-Phase Regulatory & CMC Support
- Seamless handoff from non-GLP/GLP tox to cGMP Phase 1(CTM)
- Technology transfer and scale-up support
- Analytical development and validation support
- Quality and regulatory documentation support
- Reliable raw-material sourcing and supply continuity
Why Choose Ceyone?
Flexible Scale
Our capabilities span gram, kilo-lab, and pilot-scale production, delivering quantities tailored to match early-phase program requirements.
Phase-Specific Quality
We apply phase-appropriate quality and risk-based controls designed to maintain regulatory integrity without compromising development speed.
Speed & Supply Reliability
Streamlined sourcing and parallel process/analytical workflows enable fast turnaround times to help you hit critical clinical milestones.
Development Continuity
Seamless integration between our R&D synthesis teams and pilot manufacturing units eliminates bottlenecks during scale-up and tech transfer.
Popular questions
What are Ceyone's Pre-Clinical to FIH supply capabilities?
Ceyone provides phase-appropriate drug substance development and manufacturing services, supporting non-GLP discovery, GLP toxicology campaigns, and cGMP Phase 1 / First-in-Human clinical trial material production.
What batch sizes can Ceyone provide for early-phase programs?
Ceyone can deliver quantities ranging from gram-scale lots for early characterization and in vitro testing up to multi-kilogram batches for toxicology and Phase 1 clinical studies.
Are FIH batches manufactured under cGMP?
Yes. Early clinical trial materials (CTM) for Phase 1 / FIH trials are produced in cleanroom and pilot facilities adhering to ICH Q7 cGMP standards.
Does Ceyone support IND/IMPD regulatory submissions?
Yes. Ceyone provides complete analytical release data, stability data, and technical documentation required for the CMC section (3.2.S) of IND/IMPD filings.
How does Ceyone approach solid-state optimization for early-phase molecules?
Ceyone’s capabilities include analytical method development and validation, stability studies, impurity identification and characterization, reference-standard qualification and characterization, as well as CMC and regulatory support.
Can Ceyone scale up the molecule after Phase 1?
Yes. Developed processes can seamlessly transition into Ceyone’s late-phase and commercial manufacturing infrastructure as your clinical program advances.