MANUFACTURING ARTICLES
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![Education-GettyImages-498337698]( "“A Particular Set Of Skills:” Outsourcing Considerations For mRNA Therapeutics")
“A Particular Set Of Skills:” Outsourcing Considerations For mRNA TherapeuticsIn the first of this two-part article series, Jain offers us his observations on the growth of the mRNA outsourcing sector, as well as the most important learnings he’s gleaned from engaging and contracting CDMOs in this space — particularly in these “earlier” days of the RNA therapeutics industry.
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![Recording-GettyImages-851832858]( "Forum Notebook: Quick Takes From USP’s mRNA Virtual Summit")
Forum Notebook: Quick Takes From USP’s mRNA Virtual SummitThe United States Pharmacopeia held a forum in February to exchange ideas about analytical methodologies and release testing. Here's a recap of the event.
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![GettyImages-1412962783]( "Assessing pDNA Purity For Cell & Gene Therapies")
Assessing pDNA Purity For Cell & Gene TherapiesPlasmid DNA (pDNA) is used in gene therapies, vaccines, and RNA therapeutics. Along each step of development, we need to evaluate potential impurities.
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![Four Columns Barcelona Spain-GettyImages-1188394883]( "mRNA: The Fourth Pillar Of Pharmaceutical Innovation And Intervention")
mRNA: The Fourth Pillar Of Pharmaceutical Innovation And InterventionmRNA medicines represent the genesis of a fourth pillar of pharma innovation. While exciting, there are several critical challenges we must solve to strengthen this pillar, including stability and deliverability.
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![comic art style speech-GettyImages-1342084200]( "“Holy T7 Polymerase, Batman!”: R&D Considerations For More Awe-Inspiring xRNA")
“Holy T7 Polymerase, Batman!”: R&D Considerations For More Awe-Inspiring xRNAIt goes without saying we have some pretty ambitious therapeutic goals for linear mRNA and next-gen saRNA and circRNA. However, as my conversation with Koeris explored, we still have a lot of scientific and technical work/innovation ahead of us to make our RNA products “stronger” (in more ways than one).
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![GettyImages-1336155177]( "“Holy Deliverability, Batman!”: Next-Gen “Heroism” For The mRNA-[X] Space")
“Holy Deliverability, Batman!”: Next-Gen “Heroism” For The mRNA-[X] SpaceIn the first- of this two-part article, Koeris and I ford through some of the most prominent delivery-vehicle development pain-points that don’t get nearly as much conversation as they should today. Though Koeris did not sugarcoat his concerns with some of our current mRNA delivery/LNP development limitations, the questions he posed and considerations he offered give us clearer direction around where we must pursue more scientific “heroism” in the mRNA space.
MANUFACTURING VIDEOS
In this video, Russell Johnson, VP Formulation Research for RVAC Medicines, and Aalok Shah, Director of Formulation & Drug Delivery, Strand Therapeutics, discuss what industry challenges should be top of mind for experts as it relates to the regulatory paradigm, toxicity/safety, and in vivo modeling.
In this Bioprocess Online Live panel discussion, experts share the most important factors to consider when assessing the manufacturability of novel linear mRNA candidates in order to bring forward the most successful lead candidates.
While the speed of production and flexibility of mRNA are appealing, several industry challenges must still be addressed to realize the full potential and further expand its use.
The emergence of RNA-encapsulated-lipid nanoparticles has introduced a seismic shift in biopharma innovation. But how will the industry adapt to diversifying applications and scales going forward?
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1444551560-filling-aseptic-fill-finish-line]( "The Cure For The Cure")
Traditional aseptic filling solutions can introduce contamination and variability. Learn about Cytiva's commitment to finding innovative solutions and improving patient outcomes in the field of medicine.
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![GettyImages-1357908552]( "Leveraging Single-Use Technology For mRNA-LNP Drug Manufacturing")
Single-use technology is vital for ensuring the quality and expedited market entry of genomic medicines. Learn how LNP technology is paving the way for a new era of personalized, precise medicine.
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![Crispr gene editing-GettyImages-1139760176]( "The Power Couple: CRISPR And Oligonucelotides")
Drug design using CRISPR depends on long guide RNA (gRNA) sequences. Find out how this love match between long oligos and CRISPR works.
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![DNA molecules 450x300]( "Chromatographic Purification Of Plasmid DNA")
Widespread application of pDNA in gene therapy is driving increased demand and as a response, plasmid manufacturing must become more efficient with improved productivity. Intensification of chromatographic steps can help address this demand and has led to an exploration of the use of convective media (monoliths, membranes, fibre based technologies).
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![GettyImages-1090255620-lab-research-microscope-computer]( "When Is A New Biologic Ready For GMP Production?")
While there are differences by modality in DNA, RNA, and protein, find general recommendations on questions to prepare for and steps to consider when preparing to move to clinic.
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![GettyImages-1307980860-dna-rna-vial-gene]( "mRNA/saRNA Manufacturing RNA Synthesis Process And Methods")
Venkata Indurthi, Ph.D., discusses key considerations for RNA synthesis processes and methods, their impact on downstream production, and why different projects' needs may vary.
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![Feature image]( "How Pattern Search Finds Anomaly Patterns In Historical Machine Data")
Owing to the sheer volume of data streaming from sensor profiles, anomalies observed during process monitoring in historical data are extremely difficult to search due to a lack of time series search tools.
