Newsletter | June 26, 2024

06.26.24 -- A "Hot Take" on mRNA Scale-Up


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A "Hot Take" On mRNA Scale-Up

In the following multi-part “mini-series” of RNA industry “Hot Takes,” I share several aspects that jumped out at me from the BioPhorum ATMP Event — starting with several takeaways about mRNA scale-up.

How Advanced PAT Aids Quality By Digital Design In mRNA Manufacturing

QbDD is an improvement over the QbD paradigm. Here, computational models are used to characterize, monitor, control, and improve manufacturing processes.

The Pre-IND “Diaries”: What Can mRNA Makers Expect From Early FDA Engagement?

Nutcracker Therapeutics’ Oreanna Thomas shares her takeaways from a pre-IND meeting for one of the company’s mRNA therapeutic candidates.


A New Centre For Continuous mRNA Manufacturing

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.

Empowering A New Era Of Patient-Centric Medicines

Discover the challenges pharma companies are facing as they switch focus as well as the actions and technologies companies are implementing to help achieve a brighter future for patients.

How mRNA Technology Engineers Next-Generation Antibodies

Monoclonal antibodies (mAbs) stand as pivotal drug products and biochemical reagents in the 21st century. Explore how mRNA-encoded antigens could revolutionize antibody discovery.

Five Essentials For Accurate Oligonucleotide Chemistry

Explore five key areas in oligonucleotide chemistry where improvements will have a huge influence on your synthesis quality.

Establishing Analytical Methods For Emerging mRNA-Based Therapies

Here, we describe the use of cutting-edge technologies to assess critical quality attributes of both mRNA drug substances and drug products.

Uncovering Hidden CRO Contract Costs Before Signing A Contract

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.