MANUFACTURING ARTICLES
-
Antibody–Oligonucleotide Conjugates, Part 2: Manufacturing
Let's delve into manufacturing strategy, conjugation chemistry, process development and scale-up, and purification: the central manufacturing challenge.
-
Protecting The Platform: Trade Secret Protection For RNA Biotech Companies
As RNA therapeutics grow more complex and collaborative, trade secrets are becoming an increasingly important part of protecting valuable platform innovation.
-
Engineering RNA Agonists For Systemic Immunity Without Systemic Toxicity
Krieg believes the answer lies in a deeper understanding of innate immune biology and the design of RNA/DNA hybrid mimics of viral RNA and DNA that are detected by innate immune receptors.
-
Is mRNA Manufacturing Overbuilt?
mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.
-
What Oligo Manufacturing Risks Are We Underestimating?
Earlier this year, I attended the OPT Congress, where I had the great fortune of meeting consultant Marc Lemaitre. I recently sat down with Lemaitre for a follow-up interview to gauge some of the evolutions he’s been watching within the CMC landscape for oligo development. Here, he digs into the shifts in quality he’s noted, pointing out some of the potential pitfalls we may encounter in our manufacturing that could stand to impact the overall quality of our oligos.
-
RNA Oligonucleotide Synthesis: How Advanced Manufacturing Technologies Are Accelerating Innovation
From a tech perspective, the manufacturing objective is shifting toward integrated process optimization. Automated reaction control, multivariate analytics, and more can connect molecular quality with operational performance.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
A newly developed genetic engineering medium is fueling the development of cell- and extracellular vesicle-based therapies.
-
Peptones, versatile media additives derived from various sources, offer numerous benefits for biopharmaceutical production.
-
Gain insight into the recent advancements in connectivity and integration technology, the associated challenges, and the importance of a vendor-neutral approach.
-
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.
-
Precise enzyme selection in IVT reduces dsRNA byproducts and boosts capping efficiency. This ensures high-quality mRNA production while easing the burden of complex downstream purification processes.
-
Finding an experienced partner dedicated to reducing risk of contamination and capable of growing with you as project advances through clinical trial stages is essential.
-
Guidance for your plasmid DNA downstream process development, exploring cell harvest, lysis, neutralization and clarification; chromatographic purification; TFF; and sterile filtration unit operations.