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. Leverage our combined 30 years of experience in designing plasmids to match your specific needs or bring us existing plasmids ready for production.
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.
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.
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.
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.