MANUFACTURING ARTICLES
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![DNA strands, genetic biotechnology, gene cell-GettyImages-2154784301]( "Inside Arbor Biotech's In Vivo Gene Therapy Approach")
Inside Arbor Biotech's In Vivo Gene Therapy ApproachFollowing recent news about first-in-human testing, two executives discuss the science and manufacturing strategy for the company's lead candidate, ABO-101.
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![GettyImages-2152639905-five-5]( "5 Takeaways From The MHRA mRNA Guidance")
5 Takeaways From The MHRA mRNA GuidanceHaving read and reread the MHRA's guidance on personalized mRNA cancer immunotherapies, the following five takeaways will function somewhat as a mind-meld, combining a few of my own thoughts/takeaways with those of the MHRA.
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![Lab worker examining samples-GettyImages-1635834680]( "Tales From The Trenches: Developing Potency Assays Outside Big Pharma")
Tales From The Trenches: Developing Potency Assays Outside Big PharmaLessons learned from developing potency assays to detect activity and variation for cell- and receptor-mediated products — beyond the comforts of a well-heeled company.
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![PCR machine Thermocycler for DNA or RNA quantification-GettyImages-1227432556]( "A Flexible Mindset For Bridging Between Cell-Based Assay Groups")
A Flexible Mindset For Bridging Between Cell-Based Assay GroupsTransferring cell-based assays for biologics starts with defining operator and equipment parameters, positive and negative controls, and a sufficient dynamic range.
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![Wisdom-GettyImages-2081708517]( "Enzymatic Ligation: The Next Chapter In siRNA Manufacturing")
Enzymatic Ligation: The Next Chapter In siRNA ManufacturingDuring my three days at TIDES, I sat through several talks about the industry’s progress toward enzymatic ligation approaches for siRNA manufacturing. In the following article, I’ll share a few of the biggest takeaways I garnered from these different presentations, with a particular focus on the efficiencies the industry hopes such efforts unlock in the long-term.
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![judges gavel on great britain flag-GettyImages-184134541]( "7 New MHRA Guidances To Help You With Decentralized Manufacturing For Cell And Gene Therapies")
7 New MHRA Guidances To Help You With Decentralized Manufacturing For Cell And Gene TherapiesThe U.K.'s MHRA has followed through on its promise to issue guidances to aid industry in understanding the recent changes to regulations for licensure of medicines employing cell and gene therapy technology.
MANUFACTURING VIDEOS
Advancements in single-use technologies are transforming antibody-drug conjugate manufacturing and offering increased flexibility. Examine key data, design considerations, operational benefits, and applications in ADC production.
Experts from this Advancing RNA Live panel discuss the results from a poll question revealing the top three areas RNA industry experts would be most interested in seeing additional mRNA-specific guidance from regulatory agencies.
Delve into the crucial role of Scope 3 emissions in the biopharma industry's sustainability journey, and learn more about the challenges and opportunities of managing these types of emissions.
Ribonucleic acid technologies are often characterized as “plug and play” technologies, with inherent advantages in rapidity of early development of drug candidates, but how does the next wave of technologies challenge this assumption? In this Cell & Gene Live segment, panelists Nathaniel Wang, CEO and Co-Founder, Replicate Bioscience and Sam Deutch, EVP of Research and Early Development at Nutcracker Therapeutics, discuss the lessons that next generation RNA engineers take from previous iterations of the technology.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-532549174-lab-bioreactor-development]( "From Good To Great: Innovative Biopharmaceutical Manufacturing Is Key")
Advanced manufacturing can produce new technology like mRNA within cGMP requirements and demanding timelines. What does this mean for scalability and continuous manufacturing?
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![Crispr gene editing-GettyImages-1139760176]( "The Power Couple: CRISPR And Oligonucleotides")
Drug design using CRISPR depends on long guide RNA (gRNA) sequences. Find out how this match between long oligos and CRISPR works.
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![Lipid Nanoparticle mRNA Vaccine GettyImages-1418152448]( "Fit-For-Purpose Lipids Can Accelerate, Scale, And Improve RNA-LNP Drugs")
Emerging biotech companies are investing in novel delivery capabilities to address different modalities' needs and extra-hepatic delivery. Explore steps to accelerate commercial nanomedicine delivery.
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![iStock-1293772874-lab-plasmid-gene therapy-DNA]( "Residual Plasmid Quantification In Gene Therapy Manufacturing Workflows")
This article details the design and application of a Plasmid DNA - Kanamycin Resistance Gene (pDNA-KanR) kit for residual plasmid quantification in gene therapy manufacturing.
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![Lipid Nanoparticle mRNA Vaccine GettyImages-1418152448]( "A New Centre For Continuous mRNA Manufacturing")
Explore how a partnership between academia, regulatory agencies, and manufacturing organizations has the potential to reshape the way we produce and distribute mRNA-based therapies.
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![GettyImages-1311518492-vaccine-vial]( "Expanding Into New Fields Of “Cell-Grow-Culture” For mRNA Transfection")
Learn about one path forward to navigate the pitfalls with mRNA transfection and a medium to assist in lentivirus-mediated transduction of human mesenchymal stromal/stem cells (hMSCs).
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![QA-Quality Assurance-GettyImages-1184320070]( "5 Areas To Focus Your QRM Strategy For Sterile Drug Products")
Explore five areas that can form part of a quality risk management strategy to ensure the compliant manufacturing of sterile drug products.
