CRO & CDMO Services
End-to-End Synthesis Services for Research and Development
From discovery-scale custom synthesis to GMP-grade manufacturing, Keyshine Technology delivers precision chemistry at every stage of your research.
Contract Research Organization (CRO) Services
Our CRO services are designed for academic researchers, university labs, and industrial R&D teams who need high-quality custom peptides and nucleic acids with reliable turnaround and full analytical documentation.
Custom Peptide Synthesis
We synthesize linear, cyclic, branched, and modified peptides from 5 to 100+ amino acids using solid-phase peptide synthesis (SPPS) and solution-phase methods. Every batch is HPLC-purified and mass-verified.
Specifications
Scale
1 mg – 5 g
Purity
≥95% to >99%
Turnaround
2–4 weeks
Method
SPPS / Solution-phase
Capabilities
- Linear, cyclic, and branched peptides
- N/C-terminal modifications
- Phosphorylation, glycosylation, acetylation
- Fluorescent labeling (FITC, TAMRA, Cy3/Cy5)
- PEGylation and lipid conjugation
- Isotope-labeled peptides (13C, 15N, D)
Nucleic Acid Synthesis
Custom oligonucleotide synthesis for research applications including antisense, siRNA, aptamers, and modified nucleic acids. Synthesized using automated phosphoramidite chemistry with rigorous QC.
Specifications
Scale
nmol – µmol
Purity
≥90% to >99%
Turnaround
1–3 weeks
Length
Up to 100-mer
Capabilities
- DNA and RNA oligonucleotides
- siRNA and antisense oligonucleotides
- Aptamers and DNAzymes
- 2'-OMe, 2'-F, LNA, and PNA modifications
- Phosphorothioate backbone modifications
- Fluorescent and biotin labeling
Analytical & Characterization Services
Comprehensive analytical services to characterize your peptide and nucleic acid samples. We provide full CoA documentation with every order and standalone analytical services for samples synthesized elsewhere.
Specifications
HPLC
RP-HPLC, IEX, SEC
MS
ESI-MS, MALDI-TOF
AAA
Amino acid analysis
Report
Full CoA included
Capabilities
- Reverse-phase HPLC purity analysis
- ESI-MS and MALDI-TOF mass confirmation
- Amino acid analysis (AAA)
- Endotoxin testing (LAL assay)
- Solubility and stability assessment
- Certificate of Analysis (CoA) documentation
Contract Development & Manufacturing Organization (CDMO) Services
Our CDMO services bridge the gap between research discovery and preclinical development. We provide scalable, GMP-aligned manufacturing with full documentation to support regulatory submissions.
Process Development
Systematic optimization of synthesis routes to improve yield, purity, and cost efficiency. We develop robust, scalable processes that transfer reliably from lab to manufacturing scale.
Specifications
Scale-up
mg to multi-gram
Optimization
Yield & purity
Documentation
Full process records
Transfer
Lab to GMP
Capabilities
- Synthesis route scouting and optimization
- Purification strategy development
- Analytical method development and validation
- Scale-up feasibility studies
- Impurity profiling and control
- Technology transfer documentation
GMP Manufacturing
Production of peptides and nucleic acids under GMP-compliant conditions for preclinical and early clinical research. Full batch records, release testing, and regulatory documentation provided.
Specifications
Grade
GMP-compliant
Scale
100 mg – 100 g
Purity
>98% typical
Docs
Full batch records
Capabilities
- GMP-compliant synthesis and purification
- Full batch manufacturing records (BMR)
- In-process controls and release testing
- Sterile filtration and lyophilization
- Controlled storage and cold-chain shipping
- Regulatory starting material (RSM) supply
Regulatory & Quality Support
Comprehensive documentation and regulatory support to facilitate your IND, CTA, or other regulatory filings. Our quality team works alongside your regulatory affairs team throughout the project.
Specifications
Filings
IND / CTA support
DMF
Drug Master File
ICH
Q7 / Q11 aligned
Audits
Facility audits welcome
Capabilities
- Drug Master File (DMF) preparation
- Certificate of Analysis and Certificate of Origin
- ICH Q7 / Q11 compliant documentation
- Stability studies and shelf-life data
- Impurity characterization reports
- Facility qualification and audit support
How We Work With You
01
Initial Consultation
Submit your project requirements. Our scientific team reviews your specifications and responds within one business day with a feasibility assessment and timeline.
02
Proposal & Agreement
We provide a detailed technical proposal with pricing, timeline, and quality specifications. Upon agreement, a project manager is assigned to your account.
03
Synthesis & QC
Our chemists execute the synthesis according to agreed specifications. Rigorous in-process controls and final QC testing ensure every batch meets your requirements.
04
Delivery & Documentation
Your material is shipped with full analytical documentation including CoA, HPLC traces, and mass spectra. We remain available for post-delivery technical support.
Ready to Discuss Your Project?
Contact our scientific team to discuss your synthesis requirements and receive a tailored proposal.