BIO From The Editor and Guest Columns
-
New 'WEE' Urgency Raised As FDA Requires DSCSA EDDS Interoperability
6/28/2024
A June meeting showed industry is struggling to meet the DSCSA's November deadline. Eligible companies might find relief in an FDA waivers and exemptions program.
-
Inside Barinthus Biotherapeutics' Combination Immunotherapy Platform
6/28/2024
In this Q&A with Barinthus Biotherapeutics' CEO, Bill Enright, he tells Bioprocess Online about the company's combination immunotherapy platform and its mission to develop a curative treatment for hepatitis B.
-
Antibodies, Linkers, An Uber, And John Wick
6/28/2024
The challenges faced by ADC developers after a hundred-year history with the basic concept of the drug makes the recent billion-dollar bets on the modality look all the more dramatic. What gives? Where’s all this confidence coming from? It's not the antibody. It's not the payload. It's the linker.
-
System Failure Mode & Effects Analysis (SFMEA): An Alternative Approach For Analyzing Risks
6/26/2024
Your company likely uses risk matrices and FMEA for analyzing risks. This article describes an alternative approach for conducting a system failure mode & effects analysis.
-
Strategies To Tackle CAR-T Product Challenges
6/24/2024
This article describes strategies for scaling up production of CAR-T products, including the hub model, bedside model, innovation of process strategy, and more.
-
Chugai's Race To Zero Emissions At UK4 In Tokyo
6/21/2024
Chugai's sustainable model led the construction of a new DS/DP manufacturing site, UK4, in Tokyo. The company focused on eliminating three key emissions sources.
-
How Mechanistic Modeling Eases Wet Lab Dependence
6/20/2024
Mechanistic modeling mimics process steps in a computational environment, thereby substantially reducing the dependence on physical experiments.
-
What Does FDA's Draft Platform Guidance Mean For CGT Companies?
6/17/2024
Details of the FDA's highly-anticipated platform technology program were released in the form of a draft guidance. Let's explore with a former FDA/CBER regulator.
-
How Generative AI Could Change Pharmaceutical Manufacturing
6/14/2024
Despite the hype, pharma has been slow to integrate artificial intelligence. Other industries have shown how it adds value by simplifying tedious tasks.
-
Scale And Sustainability In Single-Use Systems
6/13/2024
I had the opportunity to cover a lot of ground on considerations for single-use technologies in biopharmaceutical manufacturing with Mark Petrich, Ph.D. when he joined me as a guest expert on the Bioprocess Online Live event Single Use Technologies For Bioprocessing: An Essential Update. Here are some of his insights on single-use scale and lifecycle management.