White Paper

Setting The Standard For Plasmid DNA Production

Mutated DNA-molecules-GettyImages-1407781732

This content was created by Boehringer Ingelheim BioXcellence™

At Boehringer Ingelheim, we are dedicated to transforming lives for generations by providing innovative medicines to those in need. Our expertise in plasmid DNA (pDNA) manufacturing highlights our commitment to microbial technology, as pDNA plays a pivotal role in developing genetically engineered pharmaceuticals, driving advancements in recombinant protein technology and gene therapy. This innovative approach expands the possibilities of personalized medicine, positively impacting patients worldwide.

Plasmid DNA is a small, circular, double-stranded DNA molecule distinct from chromosomal DNA, primarily found in bacteria. It can replicate independently and is vital for genetic engineering and molecular biology due to its ability to carry and transfer genes between organisms.

The applications of pDNA in medicine are diverse and include:

  • Gene Therapy: Plasmid DNA can deliver functional genes into patients' cells to treat genetic disorders, such as cystic fibrosis, muscular dystrophy, and certain inherited blindness conditions. For instance, in 2020, the FDA approved Zolgensma®, a gene therapy for spinal muscular atrophy, which utilizes an AAV vector produced with pDNA.
  • DNA Vaccines: Plasmid-based vaccines introduce circular DNA coding for specific antigens into patient cells, prompting the immune system to produce these antigens without causing disease. Research into DNA vaccines has accelerated during the COVID-19 pandemic, with vaccines using plasmids to instruct host cells to create the SARS-CoV-2 spike protein, eliciting an immune response against the virus.
  • Cancer Treatment: pDNA can deliver genes that encode proteins with anti-cancer properties, such as tumor suppressor genes or those that stimulate the immune system to target cancer cells.
  • Manufacturing of mRNA and Cell-Based Drugs: pDNA serves as a crucial starting material for the production of these therapies.

Advancements in genetic engineering and molecular biology continue to evolve, broadening the potential applications of pDNA in medicine. At Boehringer Ingelheim, we recognize the significant benefits these innovations offer to our customers and patients. Consequently, we have developed and continually refined a manufacturing process specifically designed to produce high-quality pDNA, harnessing scientific breakthroughs for the benefit of patients.

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