Newsletter | May 3, 2024

05.03.24 -- NK Cell Therapies: How Artiva Biotherapeutics Leverages Its "Manufacturing First" Approach

NEW PODCAST EPISODE

Circular RNA with Orna Therapeutics' Tom Barnes, Ph.D. and Advancing RNA's Anna Rose Welch

As if Orna Therapeutics' CEO, Thomas Barnes, isn't enough to draw you in to the Business of Biotech, we teamed up with Advancing RNA’s Anna Rose Welch to co-host. Learn about the therapeutic proposition of circular, or "O" RNA and why it holds great potential to best linear RNA constructs, the novel, platform- and partnership-based approaches Orna is taking to address B-cell lymphomas and Duchenne Muscular Dystrophy, and a whole lot more.

FOCUS ON PROCESS ENGINEERING

NK Cell Therapies: How Artiva Biotherapeutics Leverages Its “Manufacturing First” Approach

We caught up with Chris Horan, Artiva Biotherapeutics' CTO, to discuss natural killer cell therapies and Artiva’s experiences and strategies with its candidate, AlloNK.

Characterizing The Effector Functions Of Therapeutic Antibodies

Understanding the Fc region of your antibody is crucial for assessing the impact on immunology, safety, and efficacy. Explore how to determine the most efficient way to test functionality.

A Scalable And Robust Lentiviral Platform For GMP Manufacturing

Review a well-established platform process for lentiviral vector (LV) production based on transient transfection of serum-free cells grown in suspension.

How Biologics Process Development Can Accelerate Your Path To Market

Learn how a partner with expertise and a comprehensive range of services can help companies create efficient and effective manufacturing processes, ultimately leading to successful commercialization.

CQAs: Their Importance & Limitations In Product And Process Development

What quality attributes may be similar across products, and which will be different? Explore the important differentiation of what is a critical quality attribute (CQA) versus a quality attribute.

Comparing Analytical Approaches For AAV Characterization

Explore evidence that mass photometry is a favorable method due to its accuracy, versatility, and low time, sample, and expertise requirements.

Bridging The Gap Between Cell And Gene Therapy Promise And Practicality

Delve into the current challenges and opportunities of therapeutic targets, manufacturing processes, and regulatory frameworks for CGTs and realize the full potential of these revolutionary therapies.

Benefits Of QbD: Drug-Device Combination Products And Partnerships

Quality by design (QbD) achieves quality through an understanding of all components and processes, with a detailed understanding of risks and how they can be mitigated.

Comparison To And Advantages Over Traditional Chemometrics Models

As Raman spectroscopy, with partial least squares (PLS) models, becomes more popular in bioprocesses applications it's important to recognize the challenges this approach presents.

De-risks Your Monoclonal Antibody Scale-Up Process

Improve your mAb production by adopting a technology platform approach using a fluid handling system that can transition from development to your final production volume.

8 Ways Osmolality Tests Improve Cell & Gene Process Dev, Manufacturing

Emerging and novel uses for osmolality testing in advanced therapy production is helping developers address the challenges of making cell and gene therapies accessible to larger patient populations.

Engaging Early In Process Development To Bring mRNA Sequences To Life

Examine why template sequence characteristics are relevant for cGMP manufacturing of high-quality mRNA and consider insights on how to develop a scalable, robust, and economically viable process.

Transitioning From Gel Clot To Kinetic Testing

Learn why endotoxin testing has become integral to the development and quality control of injectable pharmaceuticals and medical devices and the development and advantages of kinetic LAL assays.

High-Concentration Drug Manufacturing Challenges And Opportunities

The demand for high-concentration/subcutaneous drugs is on the rise. Explore opportunities for enhancing your biotech drug production platform.

PROCESS ENGINEERING SOLUTIONS

LNPs In 90 Seconds Or Less With This Benchtop IJM System - Helix Biotech

VirusGEN Transfection Reagent For GMP AAV Vector Production - Mirus Bio

New Solutions For Large Molecule Analysis - Danaher Life Sciences

FOCUS ON FACILITIES DESIGN

Shocking! Biotech Facilities Don't Maintain Themselves

Don't get trapped in the misconception that only core process systems need maintenance. Here are some real-life examples of facility maintenance programs gone wrong.

Forget Lean Cleanroom Construction, Practice Lean Installation

Lean construction, as a buzzword, gets a lot of play in the cleanroom industry for good reason. It is an idea that got its start with Toyota in the 1950s to maximize efficiency and eliminate waste in production.

What Is An Aqueous Cleaner?

This chapter of The Aqueous Cleaning Handbook explains what an aqueous cleaner is, what it contains, and how it can improve your cleaning process.

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