MANUFACTURING ARTICLES
-
![Utility teamwork-GettyImages-2211320040]( "From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA Policy")
From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA PolicyIn this article, I’ll share some of the progress AMM has made and the barriers the organization/our industry is still facing in our efforts to reverse the policy decisions that have been made against mRNA today. Throughout the panel, the speakers also shared their thoughts on the types of messaging we should be considering and/or have started to see making an impact.
-
![GettyImages-1493586956-assay-bottles-laboratory-scientist]( "What You Should Know About USP's Bioassay Updates")
What You Should Know About USP's Bioassay UpdatesThe United States Pharmacopeia is overhauling general chapters to align them with current industry standards. One scientist on the project helps us unpack the changes.
-
![vacation-GettyImages-1430503053]( "New Group Wants 'Phase-Appropriate' Thinking To Retire")
New Group Wants 'Phase-Appropriate' Thinking To RetireDecisions in cell and gene therapy are not about aligning with arbitrary clinical phases but about balancing risk.
-
![Creative problem solving, skill, solution-GettyImages-2184276582]( "The Case for Process Simplification in mRNA Manufacturing")
The Case for Process Simplification in mRNA ManufacturingHere, I wanted to share a few additional details from Parrella’s presentation about the efforts he and his team at Kernal Biologics made to improve their overall mRNA-LNP COGS. Though he emphasized the amount of opportunity that exists to improve our utilization of costly raw materials/reagents, as he revealed, there are also opportunities for process simplification.
-
![cars driving on a bridge-GettyImages-1167795076]( "The RNA Synthesis Spectrum: Between Solid-Phase Roots & A Hybrid Enzymatic Future")
The RNA Synthesis Spectrum: Between Solid-Phase Roots & A Hybrid Enzymatic FutureThere were two additional takeaways I had following my conversation with Kuchimanchi, each of which depicts where there still exists quite a bit of dynamism for an industry which can claim an “established” manufacturing paradigm.
-
![Athletic Jump-GettyImages-130409478]( "Beyond Solid-Phase Synthesis: The Momentum of Oligonucleotide Manufacturing")
Beyond Solid-Phase Synthesis: The Momentum of Oligonucleotide ManufacturingOverall, there were three main takeaways I gleaned from our conversation that suggest the oligo sector, though more established than its mRNA cousin, is not comfortable with the status quo and is actively trying to grow beyond the limits of its current manufacturing paradigm. Here in part 1, we’ll start with my number one takeaway, which also comes equipped with a bit of history as to how we find ourselves at our current juncture.
MANUFACTURING VIDEOS
Chief Scientific Officer and Founder Christian Cobaugh, Ph.D., examines the critical quality attributes of mRNA and LNPs that are pivotal to enhancing drug efficacy and safety.
In this Advancing RNA Live clip, panelists Stu Sundseth, Marc Wolfgang, and Christian Dohmen each provide their take on the most critical areas for improvement in mRNA process development.
Cell & Gene: The Podcast Host, Erin Harris, welcomes Romesh Subramanian, Ph.D., CEO of Ascidian Therapeutics, a Boston-based biotech focused on rewriting RNA to the pod. During the episode, Subramanian defines RNA exon editing, and they discuss the differences between RNA exon editing and gene editing. With current programs in ophthalmology, neurological and neuromuscular disorders, as well as rare diseases, Subramanian explains the overwhelming potential of RNA exon editing.
What is Bio-Layer Interferometry (BLI)? Watch to learn about BLI and the advantages of utilizing a proven BLI platform.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![Data analytics iStock-1249408894]( "Data Utilization For Advanced Analytics And Near Real-Time Monitoring")
Control, monitor, and analyze equipment, processes, results, and data in near real time and make data-driven decisions at both the process and plant levels.
-
![GettyImages-1339300422 CAR T-Cell Immunotherapy]( "How To Successfully Isolate Your T Cells")
Explore the results of a study focusing on the early stages of the CAR T cell workflow, specifically the initial washing of leukapheresis followed by the isolation of T cells.
-
![GettyImages-1371707479-lab-mask-team-partnership]( "mRNA/saRNA Manufacturing RNA Program Development & Support")
Venkata Indurthi, Ph.D., shares his knowledge and experience with manufacturing RNA, including key upstream and downstream considerations that go into process development for RNA drug substance manufacturing.
-
![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.
-
![GettyImages-508496956-dna]( "mRNA: Challenges And Strategies Related To The DNA Template Process")
Encapsulated mRNA–LNP creation begins with synthesizing the DNA template. Explore insights on DNA template synthesis, the challenges and strategies of generating a DNA template using PCR, and more.
-
![GettyImages-1097343012 lab, production, manufacturing, bioprocessing]( "Production And Clarification Of Lentiviral Vectors")
Explore scalable processes for lentiviral vector production and clarification at the 50 L scale, utilizing the CTS LV-MAX system and single-use bioreactors for robust gene therapy manufacturing.
-
![171026-101024_MDA_F61_12673_FINAL]( "Integrated Approach In Managing CPV And APQR")
Many companies continue to manually collect data. Utilizing digital technologies can greatly improve productivity and efficiency by enabling real-time monitoring and streamlining regulatory reporting.
