MANUFACTURING ARTICLES
-
![intelligent technology interface, robot chat-GettyImages-2279572840]( "Analytical Platforms: The Foundation Of The Next Generation Of RNA Therapeutics")
Analytical Platforms: The Foundation Of The Next Generation Of RNA TherapeuticsRNA therapeutics are entering a new era where analytical platforms drive scalability, regulatory confidence, manufacturing flexibility, and the development of increasingly complex products.
-
![nucleic acid, DNA, RNA, purified protein-GettyImages-1350828873]( "A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA Products")
A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA ProductsNIST research introduces a gentle SEC method that separates dsRNA impurities from IVT mRNA by tweaking buffer pH, achieving 81.8% target recovery without transcript damage.
-
![Leukodystrophy Awareness Month-GettyImages-2166836167]( "The Preclinical Gauntlet: Securing Capital And Designing Regulatory Pathways For Ultra-Rare ASO Drugs (Pt. 2)")
The Preclinical Gauntlet: Securing Capital And Designing Regulatory Pathways For Ultra-Rare ASO Drugs (Pt. 2)SynaptixBio CEO Dan Williams explains why funding, regulatory strategy, toxicology, and disciplined execution — not just science — determine success in advancing ultra-rare ASO therapies.
-
![MacKay suspension bridge-GettyImages-2281791194]( "Bridging The Atlantic: A European Executive's Guide To Building A Successful U.S. RNA Business (Pt. 2)")
Bridging The Atlantic: A European Executive's Guide To Building A Successful U.S. RNA Business (Pt. 2)European RNA biotech leaders can accelerate U.S. success by aligning fundraising, partnerships, manufacturing, hiring, and regulatory strategy from day one.
-
![GettyImages-1494348289_lab microscope]( "The Delivery Challenge For In Vivo Cell Engineering")
The Delivery Challenge For In Vivo Cell EngineeringAs RNA therapies expand beyond the liver, delivery—not payload design—has become the defining challenge for precise, scalable in vivo cell engineering.
-
![GettyImages-480155972_Leukodystrophy]( "Building An ASO For TUBB4A-Related Leukodystrophy (Pt. 1)")
Building An ASO For TUBB4A-Related Leukodystrophy (Pt. 1)SynaptixBio CEO Dan Williams explains how the company selected an ASO for TUBB4A leukodystrophy by balancing potency, safety, and translational rigor to advance a rare disease therapy.
MANUFACTURING VIDEOS
Explore the features of this benchtop system including the dual pump module, mixer module, collection module, software, and additional features.
Listen in on a discussion reviewing key drivers behind the flurry of activity in mRNA therapeutic development and begin to address the rate-limiting risks to mRNA therapeutic development.
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.
In this Bioprocess Online Live panel discussion featuring John Stubenrauch, Ph.D., Chief Operations Officer at Nutcracker Therapeutics, and Hari Pujar, Ph.D., Chief Operating Officer at Tessera, explore the impact of and how to potentially mitigate issues posed by raw material variability.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![Primrose - dsRNA 1]( "Lessons From Benchmarking Of dsRNA Across Polymerase Systems")
Not all low-dsRNA claims hold up under direct comparison. A 15-enzyme IVT study identifies the few systems that actually deliver across yield, integrity, and dsRNA simultaneously.
-
![GettyImages-1622519985 cryopreservation, cold chain]( "Optimizing Leukapheresis Cryopreservation For CGT")
Discover how an automated cryopreservation process is reshaping the leukapheresis supply chain and driving progress in the future of cell and gene therapy.
-
![GettyImages-648181930-viral-development-vaccine-lab]( "mRNA/saRNA Manufacturing - RNA Therapeutic Delivery And Applications")
Venkata Indurthi, Ph.D., shares his knowledge and experience with manufacturing RNA, including insight into RNA delivery and the applications–present and future–that innovations in the field are enabling.
-
![doctor holding vial of medicine-GettyImages-1287223643]( "Effective Strategies To Minimize Product Loss During Fill Finish")
Every drop of high-value biologic lost in fill finish is money left on the table. Learn practical strategies to protect your yield.
-
![GettyImages-525440891-lab-research-development]( "Avoiding The Pitfalls Of LNPs And Complex Formulations")
Explore the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.
-
![iStock-1140779660-drug-development-lab]( "Enabling Continuous Manufacturing For CAR-T And LNP-Based Therapies")
Breakthrough therapies are challenged by complex, batch-based manufacturing. A novel, integrated system enables continuous processing, improving consistency and reducing manual handling for advanced modalities.
-
![Gene Therapy GettyImages-1164556175]( "Advancing Cell And Gene Therapy Clinical Development In 2023")
Examine considerations on bringing together the CMC and clinical teams early in the development process, promoting transparency and communication with regulators, and increasing patient access and diversity in clinical trials.
