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Plasmid Manufacturing

AmplifyBio leverages a wide-range of plasmid DNA manufacturing services to meet our client’s precise requirements and applications. Our plasmid DNA manufacturing services cater to the full-range of development stages and applications our clients may be in, from preclinical research to clinical trials through to commercial manufacturing. AmplifyBio has a combined 30 years of experience in designing plasmids to align with your specifications or bring us existing plasmids ready for production.

Plasmid DNA Manufacturing Services

We provide comprehensive assistance in upstream and downstream process development for any plasmid DNA production project, regardless of end grade needed, in a very rapid turnaround time.  The AmplifyBio team has an extensive background  in cell therapy, gene therapy, and gene modified product development and manufacturing and understands the importance of quality, consistently made plasmids as a tool in research and development.  

Research Use Only

Plasmid for research use only. Produced using the same process and similar quality materials but without full quality oversight. The intent is to represent GMP-quality plasmid for process development and testing.  

Preparatory GMP

High-quality plasmid made in the same manner as our GMP grade but provided with the appropriate documentation level to support early phase work.  Appropriate for an early phase but not commercial use. Quality assurance ensures the product meets final specifications, including sterility and safety.  Some clients may use this in products where the plasmid is a raw material and is filter sterilized in the final product


Phase I, II, III, and commercial grade manufacturing.  Made with full quality services, in GMP labs, and with regulated grade material.

Available Services for Plasmid Manufacturing

AmplifyBio’s Plasmid manufacturing services offer efficient and reliable production of customized plasmids for diverse research and industrial applications. These services employ advanced techniques to ensure high-quality plasmids with accurate DNA sequences, allowing researchers to streamline their experiments and accelerate scientific discoveries and insights. Our available plasmid manufacturing services include:

  • Scale-up and manufacturing of existing plasmid constructs   
  • Proven manufacturing and purification processes for high recovery
  • Standardized manufacturing platforms   
  • Cell banking capabilities       
  • Early stage process development (refinement of transformation, culture conditions, etc.)
  • Downstream process development (optimization of purification and formulation conditions)                       
  • Process and change control                       
  • Fill/finish and vialing                     
  • Document support for IND filing              
  • Master Batch Records                    
  • Stability studies (optional)                          
  • Product release tests                    
  • Manufacturing in CGMP suite with graded air                               
  • Complete QC monitoring throughout the production process                 
  • QA Oversight for production       

AmplifyBio Advanced Therapy Manufacturing Services

AmplifyBio provides additional advanced therapy manufacturing services and solutions. AmplifyBio uses the latest in cutting-edge bio technology for the manufacturing of advanced therapies while also providing end-to-end support in the development and production of cell and gene therapy manufacturing, mRNA (coming soon), viral and non-viral gene editing processes, and plasmid manufacturing. Our new, state-of-the-art facilities and experienced research team enable streamlined processes and adherence to strict quality standards, facilitating the advancement of innovative therapies from concept to commercialization.

AmplifyBio Additional Services

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Comprehensive service programs for the development of Cell and Gene Therapy (CGT), mRNA, and other advanced therapies from concept to commercial. Offering expertise and support in discovery, characterization, preclinical CRO safety testing, and scalable manufacturing in an integrated, innovation-rich environment that exceeds the value proposition offered by traditional CDMO and PDMO contract models.