MANUFACTURING ARTICLES
-
![path of exponential growth-GettyImages-2229192052]( "Trends In Oligo Scale-Up & Delivery & How They're Impacting Manufacturing")
Trends In Oligo Scale-Up & Delivery & How They're Impacting ManufacturingHere, a panel of experts at the RNA Leaders Conference give a fantastic overview of where we are today and why, as one expert so nicely put it, “This is one of the most fun times to be an oligo scientist or chemist.”
-
![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.
MANUFACTURING VIDEOS
Discover how our advanced capabilities in Hopkinton, MA, are overcoming the challenges of large-scale RNA therapeutic manufacturing, enabling the efficient production of complex srRNA and mRNA therapies.
Discover key strategies for overcoming challenges in the industrial-scale production of ionizable and PEG lipids to optimize mRNA vaccine formulation and address critical manufacturing requirements.
Peptones can significantly boost CHO cell bioprocessing. We analyze their impact on diverse CHO cell lines using real-world data to assess their effects on titer, protein quality, and cell growth.
Watch an overview of the newest addition to Cytiva's single-use chromatography system family, an interview with Louise Taylor from CPI, system and software demonstrations, and a Q&A session.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![GettyImages-1357908552-rna-ribonucleic-acid]( "Expand Your Toolbox For Quality mRNA Manufacturing")
Explore guidelines for the use of SP6 RNA Polymerase in mRNA synthesis and your mRNA production processes.
-
![Cell Lab GettyImages-1183901928]( "Bringing Allogeneic Cell Therapy To Patient Care")
Bringing allogeneic cell therapy to patient care will require flexible, closed, and automated solutions to support the treatment options and increasing scale of the industry.
-
![Software Analytics]( "Bio4C ProcessPad™ 21 CFR Part 11 Compliance")
Learn how Bio4C ProcessPad™ meets 21 CFR Part 11 requirements including unique usernames and passwords, timestamped audit trails, and secure storage of all records.
-
![iStock-1296757866-research-lab-flask-microscope]( "Understanding Sterile Filtration And Importance Of Prefiltration")
Learn more on the importance of sterile filtration and how sterile filters are validated by the manufacturer and review the process and value of selecting the best prefilter to improve final sterile filtration performance.
-
![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?
-
![GettyImages-1327624070-lab-research-development]( "mRNA Manufacturing: Overcoming CMC Development Challenges")
A lack of standardization and cost-effective techniques for manufacturing and analytics for product characterization create CMC challenges for mRNA-based products.
-
![GettyImages-1295693748-mRNA]( "Current And Emerging Technologies To Optimize mRNA Manufacturing")
Explore the benefits of using mRNA for vaccines and therapeutics, and learn how to address technical, intellectual property, and cost considerations when considering commercial production.
