CMO/CDMO Services

Always a Team Player.
Trusted API manufacturer, covering process development, optimization, and GMP manufacturing.
Recognized worldwide as a dependable and innovative API supplier.

CMO/CDMO Services (Why Cerna API Solutions)

Innovative API Development through Synthesis & Fermentation

End-to-end services from pre-clinical through commercial stage

Process Modification, Scale-up, Development, Validation

Analytical Method Development & Validation

Stability Study follows ICH Guideline

CMC Documentation Preparation

GMP Inspection Contact Us

Fermentation Technology

Fermentation technology is one of the core competencies of Cenra API Solutions' enabling customized solutions and production at various stages, including the following:

Fermentation Strain Productivity Improvement
Fermentation Process Development
Scale-up & Commercial Production
Downstream Purification Process Development
Recombinant Peptide/ Enzyme Production
Enzymatic Reaction

Chemical Synthesis Technology

Synthesis route development
Process Development, Optimization
Scale-up Study & Commercial Production

Chemical Reaction Capability:

Esterification
Etherification
Formylation
Friedel-Crafts Reactions
Grignard-Reactions
Halide exchange
Hydrazine chemistry

Hydrogenation
Hydrogenation, catalytic
Nitration
Organometallic chemistry
Reduction
Vilsmeier-Reactions
Peptide syntheses

Advanced Peptide Synthesis and Semi-Synthetic Technologies

Cenra API Solutions offers a full spectrum of peptide synthesis and semi -synthetic Recombinant peptide technologies, allowing us to handle peptides of varying lengths, structural complexity, and functional requirements.

Liquid Phase Peptide Synthesis (LPPS)

Suitable for short to medium-length peptides and specialized fragments requiring high flexibility or challenging chemistries.
Representative API: Carfilzomib, manufactured through Boc- based LPPS.

Solid Phase Peptide Synthesis (SPPS)

Ideal for medium to long peptides, especially those requiring difficult sequence assembly.
Examples include Etelcalcetide, Difelikefalin, and Setmelanotide, demonstrating our ability to handle disulfide bond formation, small chain peptides, and highly sensitive building blocks.

Fermentation and Semi-Synthetic approach

For complex peptide APIs that leverage both biotechnology and chemical steps.
Representative project: Semaglutide, produced through hybrid fermentation and synthetic methodologies to achieve ultra high purity and effective control of High Molecular Weight Proteins (HMWP) and unidentified impurities.

Hybrid Convergent Peptide Synthesis

Specialized expertise in multi fragment assembly and controlled disulfide bond formation.
Representative project Plecanatide, a medium‑chain peptide containing multiple disulfide bridges and requiring highly sophisticated purification processes.
By leveraging these diverse technologies, we design the most suitable synthetic route for each peptide—achieving optimal cost efficiency, high purity, and robust scalability.

Analytical Capability

Comprehensive analytical services are available, including physical, chemical property testing, polymorph analysis, reference standard preparation and qualification, analytical method development and validation, as well as ICH-compliant stability studies.

Dedicated Analytical Equipment for R&D

Spectroscopic Analysis

LC-MS (QDA, ION TRAP, TQD, TQ ABSOLUTE)
GC-MS(Single Quadrupole)
ICP-MS

Fluorescence
Spectrophotometer
FT-IR

UV-Vis
Circular Dichroism

Chemical Property Analysis

HPLC/UPLC/ARCLC (UV,PDA,CAD)
Fluorescence
RI, Conductivity
ELSD

GC/HSGC (FID,ECD)
Capillary Electrophoresis
Ion Chromatography
Amino Acid Analyzer

Auto-titrator
Stability Chamber
Photo Stability Chamber
TOC

Physical Property Analysis

VT-XRPD/VH-XRPD
DSC
TGA
Particle Size Analyzer
Dynamic Vapor Sorption

Melting Point Apparatus
Refractometer
Turbidimeter
Optical Microscope
Karl Fischer

Polarimeter
Dissolution Tester
(Apparatus I, II, & IV)
Conductivity Meter