Newsletter | April 17, 2024

04.17.24 -- What's In The Vial?! A Meditation On mRNA Control Strategy

FEATURED EDITORIAL

ARW’s ATMP Manufacturing Must-Reads (ECLIPSE EDITION!)

Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional roundup article. Given April 8th's eclipse, I was feeling particularly inspired to make this round-up “eclipse”-themed  and lucky for you, there are tons of songs about eclipses (both celestial and otherwise), some of the lyrics from which also “cross" over into ATMP CMC.

What’s In The Vial?! A [Brief] Meditation On Control Strategy

Speakers in The State Of The mRNA Supply Chain event tackle an audience member’s question around what matters most: What’s in the vial or what’s in the process?

The Future Of mRNA For Cancer Treatment

As additional mRNA-based cancer immunotherapies vaccines enter clinical development, operational and supply chain challenges must be addressed to reduce turnaround times and COGS.

A Guide To Proactive Supplier Management In The Pharma/Biotech Industry

Proactively mitigate supply disruptions with strategic supplier selection and diversification, effective communication, risk management, quality assurance, and more.

INDUSTRY INSIGHTS

Don’t Sign Yet: How To Detect And Avoid Hidden CRO Contract Costs

Navigating the complex landscape of clinical trials can be challenging. Utilize this reliable CRO Checklist to empower teams to stay ahead and safeguard every trial's budget effectively.

mRNA Product Purification Process Strategies

Impurities from IVT can induce undesired immune responses and negatively impact translation efficiency. Explore the pros and cons of each option for mRNA purification.

Determining RNA Integrity And Purity By Capillary Gel Electrophoresis

To ensure mRNA product quality, it's important to confirm the integrity of the RNA. Examine the results of a study challenging the performance of the CGE method in assessing mRNA integrity and purity.

Study Viral Infection In Resting Human CD4+ T Cells

Explore a study proving how synthetic single guide RNAs were used to optimize the editing conditions for resting human CD4+ T cells and maintain high cell viability for several weeks post Nucleofection.

Harnessing mRNA As A Readout To Develop Robust BioPotency Assays

Discover a new potency bioassay using RT-qPCR to assess relative transcription activity and learn more about the advantages and limitations of transcriptional assays versus reporter gene assays.