Ampliphi Bio

Our Services

key Features
end-to-end solutions

full analytical testing

scalable manufacturing

animal-free manufacturing

customized approach

regulatory support
.
research to clinical grade

sterile fill & finish

plasmid DNA

From early research to clinical trials, we deliver high-quality plasmid DNA designed to meet your project’s needs. Our solutions are scalable, GMP-compliant and trusted by developers worldwide.
Research & Preclinical Grade Plasmid

Supporting early development and pre-clinical studies with consistent and reliable pDNA.

We offer:

  • Optimized fermentation for high yield
  • Advanced purification for research-grade purity
  • Scalable systems for small to mid-scale projects
  • Reliable quality for diverse applications
clinical grade plasmid                         

Delivering GMP-grade pDNA for vaccine and therapeutic development.

We Offer:

  • GMP-compliant plasmid DNA production
  • Fermentation and purification optimized to clinical standards
  • Clinical-grade formulations for trial requirements
  • Comprehensive QC and release testing

Messenger RNA

We provide cutting-edge mRNA solutions to accelerate both research and clinical programs. With advanced transcription and purification processes,
we ensure reliable, scalable and regulatory-compliant mRNA production.
Research & Preclinical Grade Plasmid

Empowering early-stage research and pre-clinical studies with high-quality mRNA.

We Offer:

  • Custom mRNA production for pre-clinical use
  • plasmid production, purification & linearization
  • In vitro transcription process development
  • Analytical testing & stability studies
clinical grade plasmid                         

Delivering GMP-grade mRNA for therapeutic and vaccine development.

We Offer:

  • Scalable GMP-compliant production
  • Purification optimized to meet strict purity standards
  • Clinical-grade formulations for trial requirements
  • Comprehensive QC and regulatory compliance
CELL BANKING
STARTING AND RAW MATERIALS
PROCESS ROBUSTNESS AND SCALE
PRODUCT ENVIROMENT
MATERIAL QUALITY 
FINAL FORMULATION SELECTION
DOCUMENTATION REQUIREMENTS
QUALITY ASSURANCE OVERVIEW
CONCENTRATION AND HOMOGENITY
BIOPOTENCY (BASED ON CUSTOMER-SPECIFIC REQUIREMENTS)
PHYSICAL PROPERTIES
IDENTITY
PROCESS-AND PRODUCT RELATED IMPURITIES
SAFETY TESTS
PRODUCT-SPECIFIC METHODS

Fill & Finish

We provide GMP-certified sterile fill and finish services that ensure the highest standards of quality, safety and regulatory compliance. Our advanced facilities handle the entire sterile filling process for active pharmaceutical ingredients (APIs), biologics and sensitive formulations, guaranteeing product safety, stability and integrity.

our capabilities                         
  • GMP-compliant processes
  • Aseptic filling techniques
  • Precise dosing
  • Scalable solutions for clinical trials and commercial production
  • Automated and manual filling options
our options                         
  • Liquid filling
  • Lyophilization (Freeze-drying)
  • Encapsulation
  • Spray-Drying
  • Labelling & Packaging