High-Quality Plasmid DNA
Clinical Readiness. Domestic Security. Exceptional Value.
Novel Bio's High-Quality (HQ) Grade plasmid DNA delivers cGMP-aligned manufacturing rigor in a streamlined, cost-effective model. Reduce costs by 50% or more compared to traditional domestic manufacturers while maintaining quality standards and your timeline. We provide milligram to gram quantities starting at 4 weeks to release.
A Strategic Alternative to Full cGMP Manufacturing
As your program matures, you need plasmid DNA that meets regulatory expectations without the overhead of full cGMP production. Novel Bio's HQ Grade pDNA is manufactured utilizing single use equipment in segregated, controlled-access facilities that adhere to the core principles of cGMP, including traceability, document control, utilization of single-use equipment, and material segregation, making it suitable for pre-clinical studies through Phase I/II trials.
What sets HQ grade apart:
Manufactured under cGMP-aligned protocols in dedicated production suites
Comprehensive analytical release testing with endotoxin clearance aligned with FDA guidance
Full chain-of-custody documentation supporting regulatory submissions
Qualified as a critical or ancillary raw material for clinical trial applications
Seamless tech transfer pathway to full cGMP when your program scales
Comprehensive Quality Control for Clinical Confidence
In addition to standard release testing, we support additional assays and services to meet your specific regulatory requirements.
Bioburden
Mycoplasma
Residual Kanamycin
Sterility
Stability
Your US-Based Plasmid Manufacturing Partner
Choosing Novel Bio for HQ plasmid preparation secures a partnership focused on the long-term success of your therapeutic program. Our domestic operations and scientific depth provide the stability required as you accomplish clinical milestones.
Domestic reliability: 100% US-based manufacturing ensures the highest data security standards and eliminates the supply chain volatility of offshore sourcing. Localization guarantees predictable lead times and absolute transparency for your critical genetic assets.
Scientist-to-scientist collaboration: Our core technical team comprises advanced scientists. We thrive on optimizing purification for complex constructs and troubleshooting where others fail, providing an unmatched level of expertise.
Built for your clinical journey: We take time to understand your therapeutic pathway, regulatory strategy, and scale-up needs. From preclinical validation to your first clinical runs, our processes are designed to evolve with your program.
Integrated Support for Production Readiness
Novel Bio provides the technical infrastructure required to standardize your manufacturing process and fortify your regulatory filings. At the HQ level, these services function as the critical bridge between laboratory research and clinical-grade production.
Process standardization and scale-up: We transition your bench-top methods into robust, industrial-scale protocols, optimizing yield and purity to ensure a reproducible process for multi-gram production.
Host-vector stability audits: We conduct exhaustive stability assessments and host-strain characterization to ensure the genetic integrity of your construct during high-density fermentation.
Validated cell banking: Establish a secure, fully documented Working Cell Bank (WCB) conforming to HQ Grade specifications. Our managed banking provides the verified, traceable starting material necessary for multi-phase clinical programs.
Regulatory-grade documentation: Receive comprehensive manufacturing and release reports designed to meet the transparency and traceability requirements of regulatory submissions and quality audits.
Seamless clinical handoff: Our HQ infrastructure is a direct subset of our cGMP framework. This ensures that as your program expands, you benefit from a pre-validated technical transfer to full clinical manufacturing.