MilliporeSigma  

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.

Whatever stage of the biopharma development process you’re in, our leading cGMP-compliant testing services and regulatory knowledge can help you progress your therapeutic from discovery to release, including: Cell banking and testing, product characterization, raw materials testing, lot release testing, and clearance validation.

Concentrate and wash steps throughout the cell therapy process can be particularly challenging for a variety of reasons – low cell recovery and viability, open-processing steps, and operator error can plague this unit operation. With the ekko™ Acoustic Cell Processing System, our unique acoustic technology provides a gentle way of processing cells while maintaining cell quality. Its unmatched ease of use and flexibility support multiple cell applications, process steps, and scales. 

Millistak+® HC Pro fully synthetic depth filters are made using polyacrylic fibers and silica and have the advantage of lower water flushing requirements relative to conventional depth filters due to lower levels of extractables and absence of beta-glucan. Those designed for primary clarification, Millistak+® HC Pro D0SP and C0SP, also have four layers — rather than the two layers commonly found in other depth filters — providing a significant boost in capacity. These filters exhibit different adsorptive properties relative to traditional media, which can enable higher DNA and HCP impurity clearance. 

Product details (max 1000 characters) - Our cGMP state-of-the-art facilities accommodate separate areas for scale-up, process validation, phase III trials, and commercial launch. Additionally, our large-scale facility supports viral vector manufacturing up to 1,000 L using single-use bioreactors (SUBs). 

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. 

Benzonase® endonuclease Safety Plus is the smart evolution of enzymatic DNA removal in biopharmaceutical production. Benzonase® endonuclease has proven its value for over 30 years in viral vector manufacturing.  Balancing efficiency and regulatory compliance by delivering reliability and high-quality manufacturing under good manufacturing practices (GMP ICH Q7).  Additionally, to the stringent quality control and extensive documentation packages coming with Benzonase® endonuclease Emprove® Expert, the all new Safety Plus product elevates the high-quality level even further. Adding the most recent manufacturing and analytical technologies it delivers enhanced risk mitigation. 

The cell line engineering service partner you can trust to create customized cellular models for your drug discovery and biomanufacturing needs. With access to state-of-the-art genome editing technology (CRISPR, ZFN, and lentiviral technologies), CDS can generate knockout, knock-in, stable expression, or other modifications in any gene target and virtually any cell line.

Reduce off-target effects without a decrease in on-target cutting with PURedit™ synthetic sgRNAs and Cas9 protein. Engineered to meet superior manufacturing standards, they are guaranteed to edit with high on-target cutting, even in the most difficult-to-target loci, and do not compromise specificity.