Newsletter | November 21, 2024

11.21.24 -- Considerations For Potency Assurance Of CGT Products

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Raman Spectroscopy: Monitor In-Vitro Transcription in mRNA Manufacturing

Raman spectroscopy is an efficient method for process monitoring and control which empowers the user to navigate mRNA manufacturing with confidence. It enables the direct monitoring of molecular vibrations, offering a detailed chemical fingerprint of NTP bases and mRNA molecules without the need for labeling or extensive sample handling. Learn more about the benefits of Raman technology in IVT in our technical article. Read now!

FOCUS ON ANALYTICS & QUALITY

Considerations For Potency Assurance Of CGT Products

Confused about FDA's draft guidance on potency assays for cell and gene therapy products? Let's clarify a few things and discuss some key considerations.

Unlocking The Potential Of Digital Transformation Tools

Why do many BioPharma organizations still struggle to gain the crucial benefits they desire from their data and digital transformation tools?

Volume Verification Using Any Microtiter Plate Or Small Volume Container

Here, we discuss methods for measuring target volumes (10 nL - 200 μL) dispensed into any microtiter plate or small-volume container using the Artel MVS®.

Achieving Speed And Scale With Optimized Synthesis Solutions

Realize optimal coupling efficiency and increase your productivity for oligonucleotide drugs by selecting the right synthesizer and prioritizing automation to define and tweak synthesis methods.

Dissecting Cellular Composition Using Single-Cell Multiomics

Hear from Dr. Fabio Luciani, Professor and Senior Researcher in Systems Immunology at the School of Medical Sciences and the Kirby Institute at UNSW Sydney about his recent research.

Modern Industrial Data Architecture Strategies And Best Practices

Explore the processes and technologies being utilized by life sciences manufacturers to achieve success on their Industrial DataOps maturity journey as well as real-world best practices from the field.

ANALYTICS & QUALITY SOLUTIONS

Data Harmony – Your Data, Always Available - Eppendorf SE

Reduce The Burden Of Software Validation Testing - ValGenesis

Software Package For GMP-Regulated Environments - Refeyn

FOCUS ON REGULATORY

Obesity Tx End-Around With Skye Bioscience's Punit Dhillon

While the trend toward CB1 inhibition for obesity took a small hit with the release of Novo Nordisk's small molecule oral cannabinoid receptor (CB1) inverse agonist monlunabant last month, Skye Bioscience Chairman and CEO Punit Dhillon is shaking it off. He's confident that his company's antibody-based approach to CB1 inhibition will make a moot point of the neuropsychiatric side effects that put a damper on Novo's data. On this episode of the Business of Biotech, we're digging into the uber-hot business of weight loss therapeutics.

A Rheologist's Guide To Regulatory Confidence

Explore key rheology concepts and terminology, and learn how to generate the required rheological profiles using high-performance instruments.

How Government Funding Spurs Scientific Innovation

Review the different ways the United States government supports alternative, innovative approaches for more reliable readouts of toxicity and efficacy.

How A CDMO Gained 40%+ Efficiency By Generating Automated Annual PQRs

Discover how a CDMO's mounting challenges with manual product quality review (PQR) processes were resolved through the implementation of a next-generation cloud-based solution.

Virus Filtration: Regulations And Mechanisms

In this presentation, Dr. Nigel Jackson, Principal Engineer in R&D, offers an in-depth discussion on regulatory guidance and recent updates pertaining to virus filtration.

A Supplier-Manufacturer Approach To Mitigating Nitrosamine Risk

Learn about how nitrosamines are formed, their prevalence and chemical precursors in pharmaceuticals, techniques for quantification, and approaches for managing nitrite impurities.

FDA-Registered Detergents

All Alconox Inc. detergents are Class I Medical Devices and listed as FDA-registered detergents. The list of the detergents is found on the FDA website with FDA Registration number 2410887. Alconox Inc. is also proud to be ISO9001:2015 and ISO13485:2016 Certified.

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