Nucleic Acids

Nucleic acid-based therapeutics, such as antisense oligonucleotides and RNAi therapies, routinely incorporate modified nucleotides for greater stability and are often conjugated to other molecules to effect targeted delivery. Being able to separate these molecules from a multitude of synthesis related impurities is critically important for their characterization and CMC testing, impurities analysis, and QC release. Additionally, it is critically important to confirm the nucleotide se-quence including the location of each modification within the sequence (aka: modification mapping).

To this end, Waters offers unique high-performance column chemistries and fit-for-purpose LC-MS workflows that deliver unparalleled separations performance for oligonucleotides and support everything from  characterization and sequence confirmation to GMP validated QC release.

Featured Technology: BEH & ACQUITY PREMIER column technology, ACQUITY UPLC systems, BioAccord LC-MS system, XEVO G2-XS QTof, Vion & SYNAPT XS MS platforms, MassPREP standard, waters_connect, MassLynx, ProMass, Spectrum Tools

Viral Vectors

The presence of the desired transgene encapsidated within a viral vector is a critical quality attribute (CQA) and because there is a charge difference between the two species, quantification and separation of empty/full viral vectors can be completed using anion exchange chromatography.

Additional elements to monitor that impact transfection efficiency, selectivity, and immunogenicity include the protein subunit ratio, post-translational modifications (PTMs), and size variants. The first two are best addressed by peptide mapping and the latter can be assessed using size exclusion chromatography.

Featured Technology: BioAccord LC-MS System, UNIFI, ACQUITY UPLC H-Class PLUS Bio System, ACQUITY UPLC with FLR Detector, RP C4 300Å or C18 300Å column, Protein Pak, XBridge Protein BEH450 SEC Columns, Empower Software with Auto Blend Plus Technology, Protein-Pak Hi Res Q Column

Bioprocess Attribute Monitoring

Metabolite monitoring is a useful process in the analysis of cell culture media whether it is for a viral vector product or cell therapy propagation of either autologous or allogeneic cells. In untargeted mapping, a researcher is given freedom to discover and after the best predictors are discovered, an automated targeted validation method with Progenesis can increase efficiency.

Featured Technology: Progenesis QI, UNIFI, MassLynx, SFC, HRMS, HILIC, Triple Quad MS/MS, Patrol, AccuTag

Genomic and Cellular Biology Automation and Preparation

Scalable, consistent identification and quantitation of nucleic acids requires both accuracy and traceability built into an automated workflow. These requirements can be achieved using the highly versatile Andrew+ pipetting robot and Pipette+ smart pipetting system, benefitting from the design and execution of protocols for RT-PCR, Next Generation Sequencing, clonal isolation, and plasmid purification. Moving into to larger complexes, cell preparations for flow cytometry and staining can also be prepared using the same automation system.

Featured Technology: Andrew+, OneLab, BeadTender, Magnet+ www.AndrewAlliance.com