Thermo Scientific TheraPure phi29 DNA Polymerase is a highly processive DNA polymerase with strand displacement activity. This capability allows for highly efficient isothermal DNA amplification using a technique referred to as rolling circle amplification (RCA). This enzyme is produced recombinantly in E. coli cells using a cloned gene from Bacillus subtilis phage phi29. phi29 DNA Polymerase also possesses 3'→5' proofreading exonuclease activity that acts preferentially on single-stranded DNA or RNA.

The enzyme was developed specifically for preparation of DNA template used in the in vitro transcription reaction to produce nucleic acid therapeutics such as mRNA.

Designed for therapeutics manufacturing process development

TheraPure phi29 DNA Polymerase helps accelerate RNA or DNA vaccine and therapeutics development by providing:

• Quality—critical product quality attributes to help accelerate therapeutics development
• Secure and consistent supply—a secure, stable, and consistent supply of product at a global scale
• Smooth transition to GMP—quick and easy upgrade path to TheraPure GMP* quality level upon request
• Technical collaboration—solution-driven expert support across the production and development process

Comprehensive quality system
TheraPure phi29 DNA Polymerase is supported by an extensive quality system and documentation.

• Manufactured following ISO9001 and ISO13485 standards
• Animal-origin-free (AOF) and beta-lactam-free manufacturing processes and materials
• Extensive set of validated/verified compendial assays were applicable
• Individual product stability data

Enzyme activity

One unit of the enzyme incorporates 0.5 pmol of dCMP into a polynucleotide in 10 min. at 30°C.

*TheraPure GMP refers to the quality level of the raw, ancillary, or starting materials to be used for further manufacturing. TheraPure GMP products are manufactured in facilities with ISO 9001–certified quality management systems that operate in accordance with relevant good manufacturing practice (GMP) principles, as outlined in ICH Q7 or equivalent guidance documents or standards.