MilliporeSigma

BioReliance® Product Characterization and Analytical Development Services

It is imperative to understand product and process consistency and mitigate risk as related to safety and efficacy. We employ both classic and progressive techniques to evaluate these ICH Q6B driven Critical Quality Attributes. 

BioReliance® Biosafety Testing Services

We offer exceptional, risk-mitigating solutions with technical and regulatory expertise.  Whatever stage of you’re in, our leading cGMP-compliant testing services and regulatory knowledge can help you progress your therapeutic from discovery to release.

The Sf-RVN® Platform: a rhabdovirus-free platform that improves the safety profile of your gene therapy.

The baculovirus-insect cell system is widely used for production of recombinant proteins and clinical stage AAV due to its flexibility, speed, simplicity, and productivity. With the Sf-RVN® Platform, we provide a rhabdovirus-free cell line that improves the safety profile of your bioprocesses combined with a chemically defined medium specifically formulated to get excellent growth and productivity while adhering to evolving regulatory requirements.

This platform can enable you to dramatically reduce the time in process development and scale-up. Whether performed in your facilities or leveraging our gene therapy CDMO capabilities, you can draw on our 30+ years of viral vector manufacturing experience and a platform that can dramatically reduce your process development and scale-up time to speed your therapy to patients. 

With our new Cellvento® 4HEK medium, you can produce higher AAV titers across multiple HEK293 cell lines, maximize production of full capsids of AAV, support robust cell growth, facilitate transfection of multiple HEK293 lineages, and thus saves you time in bringing your gene therapy to life!

• Optimized for AAV Production
  • Enables high AAV titers of full AAV capsids
• Multiple HEK293 Lineages
  • Supports robust growth and AAV productivity of multiple HEK293 cell lines
• One Formula for the Entire Process
  • Easy-to-use medium for all stages like growth, transfection and production

1. Benzonase® endonuclease Safety Plus

The use of Benzonase® endonuclease can significantly reduce the levels of DNA by more than 100,000-fold while also reducing viscosity and protecting downstream equipment from DNA fouling. However, optimization strategies and DoE are critical when it comes to reducing DNA in your process. Setting up a DoE for your Benzonase® endonuclease application can help you find the optimal operation conditions that deliver the required DNA clearance from your process.

•        Intensifies downstream processes

Increased efficiency

Higher recovery

•        Helps meet regulatory expectations

Our Pellicon® Capsules are a true single-use solution for your TFF challenges. Designed for efficient single-use UF/DF, the Pellicon® Capsule is a first-of-its-kind spiral-wound TFF filter engineered to provide you with performance consistency and linear scalability for reliable process development and predictable scale-up at any stage of your gene therapies and vaccines.  Its plug ‘n play holderless format provides fast and easy installation, as well as self-containment for those processes requiring additional safety. The capsules are gamma sterilized and can integrate into our TFF systems from process development to process scale. With optimum feed channel design, the capsules perform with high flux to meet your concentration targets with speed.