ANALYTICAL/QUALITY ARTICLES
Peter Marks: An Early Preview of mRNA, Gene Therapy Platforms
Though Marks emphasized that this concept/designation at the regulatory level is still somewhat of a “we’ll-know-it-when-we-see-it” phenomenon, his remarks this summer — as well as a few additional discussions that have occurred throughout 2023 — add a bit more clarity to our understanding of what a gene therapy platform can be.
ANALYTICAL/QUALITY VIDEOS
Developing a client-sponsored Target Product Profile (TPP) and Analytical Target Profile (ATP) is critical to move your drug product to clinic efficiently and meet acceptance criteria.
Here, we describe the use of cutting-edge technologies to assess critical quality attributes of both mRNA drug substances and drug products.
Discover how to integrate appropriate materials and tools for oligonucleotide handling, optimize DNA storage using dedicated fluoropolymer film, perform complex biochemical reactions in bags, and more.
Learn about method development considerations when selecting an appropriate ion-pairing agent and impurity analysis of dye-conjugated oligonucleotides.
ANALYTICAL/QUALITY RESOURCES
-
![Scientist lab cell and gene dna GettyImages-1305079941]( "Ultra-Sensitive Assay For Anti-Sense Oligonucleotide Quantification")
Ultra-Sensitive Assay For Anti-Sense Oligonucleotide QuantificationLearn about a new level in sensitivity for challenging analytes in matrix that opens doors for accurate bioanalysis and metabolism studies with specificity not achievable with orthogonal methods.
-
![iStock-879831370-plasmid-lab-cell]( "Pre-Banking And Avoiding Manufacturing Challenges For GMP Plasmids Containing Unstable Sequence Regions")
Pre-Banking And Avoiding Manufacturing Challenges For GMP Plasmids Containing Unstable Sequence RegionsEnsuring consistent replication and proper retention of plasmid DNA sequence is vital to the economics and efficiency in generating starting materials used for production of AAV delivered gene therapy and mRNA vaccines and therapeutics.
-
![Scientist In Lab GettyImages-1354172647]( "Boost LNP Drug Potency With Optimized Delivery Formulations")
Boost LNP Drug Potency With Optimized Delivery FormulationsLipid nanoparticles (LNPs) function as a drug delivery system for nucleic acids. Learn about the biomedical applications of LNPs as well as the anatomy, formulation optimization, and safety of LNPs.
-
![Covid Vaccine Production Line GettyImages-1336518535]( "Analytics And Bioassays Can Safely Fast-Track mRNA-LNP Drug Development")
Analytics And Bioassays Can Safely Fast-Track mRNA-LNP Drug DevelopmentOne main mRNA technology challenge is the formulation of delivery systems like lipid nanoparticles (LNPs). Learn about evading impurities in lipids, the future of mRNA-based genomic medicines, and more.
-
![Solving Challenges Puzzle Maze]( "RNA: The Next Era In Therapeutic Development")
RNA: The Next Era In Therapeutic DevelopmentReview the unique set of challenges for RNA production that must be considered and solved to reach their full therapeutic potential.
-
![iStock-954300680-gene-therapy-dna]( "RNA Biotherapeutics — A New Approach To An Old Problem")
RNA Biotherapeutics — A New Approach To An Old ProblemCheck out a brief history of RNA-based therapy and how Droplet Digital™ PCR supports this field of work.
-
![Gett images-542576580 bio]( "Common Approaches To Bioanalysis Of Oligonucleotides")
Common Approaches To Bioanalysis Of OligonucleotidesWeigh an assortment of advantages and disadvantages to determine which strategy is best for a clinical study.
