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Current Analytical Challenges in Cell Line Development

The primary objective in cell line development is to create robust and stable cell lines capable of producing the desired therapeutic product with optimal characteristics and minimal impurities. A key aspect of this process is ... Continued

Using Electron Activated Dissociation for Comprehensive Characterization of O-linked Glycosylation

Glycosylation, a common post-translational modification (PTM), is crucial for antibody effector functions. Comprehensive characterization of N- and O-linked glycosylation in protein therapeutics is vital for ensuring drug safety and efficacy. The industry standard approach for characterization ... Continued

Why Teamwork and Collaboration are Necessary for Successful Viral Vector Characterization

Characterizing viral vectors presents several challenges, primarily due to their larger size compared to other biologics like fusion proteins, monoclonal antibodies, and small molecules. Their heterogeneity and complex structure further complicate characterization efforts. To address ... Continued

Ask the Expert – Adducts and N-oxides: understanding lipid nanoparticles (LNPs) for better mRNA drugs

Lipid nanoparticles (LNPs) are widely used vehicles for messenger RNA (mRNA)-based therapeutics and vaccines. However, ionizable lipids used in LNPs can be susceptible to N-oxide impurities that can cause functional loss of the mRNA cargo. In a recent webinar, available ... Continued

Better mRNA-LNPs: encapsulation efficiency, mRNA integrity and purity, lipid N-oxides, and beyond

Lipid nanoparticles (LNPs) have emerged as a popular delivery vehicle for gene therapy and vaccines due to their ability to be scaled up and their versatility to encapsulate various sizes of genetic material, amongst other ... Continued

Beyond mRNA: how advances in analytical techniques are enabling a revolution in the RNA drug landscape

Currently, there are 3 main types of in vitro transcribed (IVT) RNA drugs, encapsulated in lipid nanoparticles (LNPs). Two of these—conventional messenger RNA (mRNA) and base-modified mRNA (bmRNA), which incorporates chemically modified nucleotides—are non-replicating. The third type is self-replicating ... Continued

Achieving Detailed Characterization of mRNA-LNP Therapeutics and Vaccines with Cutting-Edge Technology

Activity in RNA-based drug research reached an all-time high thanks to the success of messenger RNA (mRNA) COVID-19 vaccines, which provided the pathway for clinical validation for this new modality. The great versatility of mRNA, ... Continued

More Fragments, Less Headaches: How Electron Activated Dissociation Can Improve Lipid Nanoparticle Analytics in Gene-Based Drug Development

In contrast to traditional biologics, drugs based on the delivery with lipid nanoparticles (LNPs) can be even more complex and pose new challenges from an analytical perspective. The genetic cargo and several different lipid classes ... Continued

mRNA-LNP integrity profiling – Ask the Expert

The use of lipid nanoparticles (LNPs) as non-viral delivery tools for nucleic acid payloads, such as messenger RNA (mRNA), has become more widely adopted in the industry not only due to its use in COVID-19 ... Continued

A Multi-capillary Electrophoresis System Speeding Development Timelines for Biotherapeutics — Run Multiple Samples in Parallel with the BioPhase 8800 system

Today, we are analyzing more drug candidates with a wider range of modalities, all with the understanding that speed to market is more critical than ever before. As a result, scientists working on these candidates ... Continued

Achieve unparalleled structural elucidation and sensitivity with the ZenoTOF 7600 system from SCIEX

Liquid chromatography with tandem mass spectrometry (LC-MS/MS) is one of the most versatile and high-performance analytical tools for the detection, characterization and quantification of biotherapeutic molecules and vaccines. However, emerging modalities require new analytical methodologies ... Continued

Rapid Spent Media Analysis of Metabolites During Cell Line Development for Better Product Quality Outcomes

Spent media analysis is an important tool used to provide crucial information about the amino acids and nutrients that cells use during growth phase. Spent media analysis also provides details about the metabolites that are ... Continued

Optimizing Characterization and Quantification of Therapeutic Oligonucleotides

Oligonucleotides (OGN) are a class of therapeutics comprised of short strings of synthetic nucleotides. OGNs have the ability to to alter, suppress or restore expression of target genes associated with disease or health. This makes ... Continued

Quantitative LC-MS Solution for Targeted Analysis of Cell Culture Media

SCIEX’s new cell culture media analysis method has been designed to meet industry demands by providing solutions to the technical challenges present in current assay development methods. Thereby enabling a successful QbD approach for cell culture media optimization with critical quality attributes in mind. At-line monitoring strengthens QbD with the ability to monitor the impact of these components and how they change in-process....Continued