MANUFACTURING ARTICLES
-
The RNA Synthesis Spectrum: Between Solid-Phase Roots & A Hybrid Enzymatic Future
There 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.
-
Beyond Solid-Phase Synthesis: The Momentum of Oligonucleotide Manufacturing
Overall, 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.
-
Inside Arbor Biotech's In Vivo Gene Therapy Approach
Following recent news about first-in-human testing, two executives discuss the science and manufacturing strategy for the company's lead candidate, ABO-101.
-
5 Takeaways From The MHRA mRNA Guidance
Having 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.
-
Tales From The Trenches: Developing Potency Assays Outside Big Pharma
Lessons learned from developing potency assays to detect activity and variation for cell- and receptor-mediated products — beyond the comforts of a well-heeled company.
-
A Flexible Mindset For Bridging Between Cell-Based Assay Groups
Transferring cell-based assays for biologics starts with defining operator and equipment parameters, positive and negative controls, and a sufficient dynamic range.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
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.
-
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.
-
What sustainable manufacturing processes best address Oligonucleotide environmental impact while maintaining scalability?
-
Both physical and chemical nonviral gene delivery systems for ex vivo genetic modification offer advantages over viral vectors, including smaller scale production and the low risk of immunogenicity.
-
Achieve the optimal nutritional balance with diverse supplements tailored for your specific bioprocess that can be added to maintain a nutritionally balanced medium.
-
One of the key concerns for many biopharmaceutical companies is minimizing environmental impact. Learn about additive manufacturing and the significant advantages it offers to biomanufacturers.
-
As oligonucleotide-based drugs gain momentum in therapeutic development, refining their manufacturing processes through solutions like ion exchange chromatography (IEX) becomes crucial.