Plasmid DNA Manufacturing Services
Reliable and timely plasmid DNA production is essential for supporting cell and gene therapy development. Our CDMO teams leverage the plasmid manufacturing platform alongside integrated in-house analytical testing to provide both custom and standardized plasmid solutions for critical starting material supply.
Through optimized production workflows and robust quality systems, we support efficient plasmid manufacturing with consistent performance and reliable timelines. These capabilities enable developers to secure high-quality plasmid DNA required for vector production and advanced therapy programs, supporting progression from early development through clinical manufacturing.
Secure and Reliable Plasmid DNA CDMO Solutions
High-quality plasmid DNA is a critical starting material for many cell and gene therapy manufacturing processes. Our comprehensive plasmid DNA manufacturing services support programs from preclinical research through clinical development and commercial supply.
Developers can provide an existing plasmid construct for production or collaborate with our teams to design and generate custom plasmids tailored to specific therapeutic applications. In addition, we provide integrated scientific support across the entire manufacturing workflow, including both upstream fermentation and downstream purification process development, to ensure reliable plasmid production and consistent product quality throughout each program.
Plasmid Linearization
We provide linearized plasmid DNA templates for in vitro transcription (IVT), produced using established platform processes and validated screening workflows. Our manufacturing approach incorporates a plug-and-play processing framework supported by in-house analytical testing to ensure template integrity and consistency.
Plasmid linearization services are available across multiple production scales, including high-quality research-grade and GMP-compliant manufacturing. Through our dedicated plasmid DNA center of excellence, we deliver reliable linearized plasmid templates to support secure starting material supply and downstream mRNA production programs.
Linearized Plasmid Starting Materials for mRNA Therapeutics
Plasmid DNA serves as a critical starting material for many advanced therapy modalities, including mRNA-based therapeutics. For mRNA production, plasmid constructs containing the gene of interest must be linearized using a restriction enzyme to generate a suitable template for in vitro transcription (IVT). The successful production of functional mRNA depends on the integrity of this template, making plasmid construction, restriction-based linearization, purification, and release testing essential steps to ensure high-quality template DNA for efficient IVT.
Our plasmid linearization services are available as a stand-alone offering or as a modular component of phase-appropriate plasmid manufacturing programs. Using a robust plug-and-play screening toolbox, we support constructs containing long poly(A) sequences that can be susceptible to truncation during processing. Our platform is compatible with a wide range of commonly used restriction enzymes and plasmid designs, minimizing the need for extensive process development and enabling efficient timelines for linearized plasmid production.
Plasmid Linearization to Support Programs from Concept to Clinical Manufacturing
Supercoiled and linearized plasmid DNA can be produced at research, High Quality (HQ), and GMP grades, with scalable manufacturing ranging from milligram to multi-gram quantities. Our integrated production and quality control capabilities ensure consistent plasmid quality and reliable supply of critical starting materials required for advanced therapy development.
The plasmid linearization module can be implemented as an add-on to the plasmid production platform, enabling standardized, efficient, and high-quality plasmid manufacturing. Leveraging single-use technologies and comprehensive in-house analytical testing, our teams support accelerated development and manufacturing timelines—typically as short as five weeks for High Quality (HQ) material and approximately ten weeks for GMP-grade production—helping maintain momentum for your therapeutic development programs.
Actcell Labs Inc
1361 Amsterdam Ave.,
Floor 3, New York,
NY 10027, USA
+1 888 4880155
support@actcelllabs.com