The Cornerstone® service for nucleic acids integrates both purification and analytics to enable the safe and efficient separation of pDNA and RNA for the manufacturing of nucleic acid-based therapeutics and vaccines. The service relies on the CIM® monolith technology, to enhance purification performance by improving efficiency, purity, yield, and process speed.
Modality-Specific Process Development Services: Plasmid DNA (pDNA), Mesenger RNA (mRNA) and other RNA modalities, including self-amplifying RNA (saRNA) and circular RNA (circRNA).
pDNA Process Development Services
We support the internal establishment of plasmid production processes at customer sites, ensuring compliance with regulatory purity specifications. Development is conducted at a scale of up to 10-liter bioreactor, including fermentation (if required), lysis optimization at a scale of up to 10-liter bioreactor, clarification, TFF, chromatography, and sterile filtration. A QbD approach including DOE is applied in development.
The DOE methodology, coupled with chromatographic purity analysis and productivity monitoring, is utilized to maximize recovery and optimize downstream purification. pDNA linearization is also available to meet specific project needs.
mRNA Process Development Services
The focus is on in vitro transcription (IVT) optimization to reduce costs and minimize double-stranded RNA (dsRNA) formation, using design of experiments (DOE) methodology with PATfix® at-line monitoring to maximize yield. Services include optimization of the capture step, dsRNA removal, and tangential flow filtration (TFF) for drug substance (DS) formulation.
Better Purification Process. Faster.
Cornerstone® Biomanufacturing Development Services solve the challenges and accelerate process development from pre-clinical to market supply. Our objective is to give the customers resources, knowledge, technical solutions and their product – in time and in the right quality.