Bioprocess Online for bioanalytics, biopurification, bioproduction

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Manufacturing chimeric antigen receptor (CAR) T-cell therapies is a costly and complicated process. Interius BioTherapeutics is on a mission to reduce this complexity and get these therapies to patients faster — by manufacturing CAR cells in patients' bodies.

EDITOR'S DESK

Inside Barinthus Biotherapeutics' Combination Immunotherapy Platform
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

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.

Scale And Sustainability In Single-Use Systems

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.

Where's The Case For Generative AI In Biopharmaceutical Manufacturing?

The early use cases for AI in the biopharmaceutical industry—at least, the early public use cases—have largely come from R&D, and more specifically, target identification and molecular design. Where are the use cases in biologics manufacturing, supply chain management, QMS, and operations, and what’s holding us back?

Bioprocessing Technology: You Are The Standard

Single-use bioprocessing equipment engineer and expert Paul Priebe has some advice for you. Next time you catch yourself questioning an equipment standard (or the lack thereof), take a good look in the mirror.

GUEST COLUMNISTS

9 Common Tech Transfer Pitfalls To Avoid
Many issues can trip up a tech transfer process. Here are nine of them— plus ways to mitigate each one.
Bacterial Endotoxin Testing, Part 2: Prerequisites & Reagent Preparation
In this second article of a planned series about bacterial endotoxin testing, the author shares best practices about prerequisites and reagent preparation for a gel clot Limulus amebocyte lysate (LAL) test.
Uncovering Cell Culture Media's Part In Latest Biopharma Trends
Cell culture media are ubiquitous in just about every bioprocess system, and advanced modalities are putting specialty media in the spotlight.
Making Good Decisions When FDA Investigators Come Knocking
Ready or not, when the FDA inspector arrives, the test has already started. New final guidance makes clear what the agency considers an attempt to stonewall.
5 Recommendations To Maximize CSV/CSA Outcomes
The computer system validation (CSV)/computer system assurance (CSA) process is correlated with other departments besides IT and quality. Accordingly, all stakeholders must think ahead and define what they need.
How Eli Lilly's Making Peptides Faster And More Reliably
Three company leaders answer questions about the IE2b project, which is receiving an ISPE 2024 Facility of the Year Award for its ingenuity of complexity.
Bacterial Endotoxin Testing, Part 1: Overview
All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.
More Case Studies: Managing Change In Vaccine Production
Part two of this series digs into real-world examples from Sanofi for getting the right stakeholders on board when altering a process or changing equipment.

BIOPROCESSING WHITE PAPERS

Using SerumSub™ QualAssure™ To Assess Liquid Transfer Performance
In this study, SerumSub™ QualAssure™, a serum-like reference solution with liquid handling properties that are analogous to several commonly used sera, is compared to various commercially available mammalian sera.

Downstream Processing In The Age Of Precision Medicine
10/26/2022

Explore alternative processes and solutions being suggested to combat the bottleneck created by downstream processing that is seriously impacting the overall production of treatments and vaccines.
Is Mannitol Hemihydrate Detrimental To Protein Stability?
12/8/2023

Maintaining an amorphous excipient matrix is crucial for protein stability. Learn about the importance of storage conditions in managing mannitol hemihydrate dehydration and ensuring protein stability.
Improving Safety And Efficacy With Charged Variant Characterization
5/14/2024

Discover how a CDMO with extensive experience in protein variant characterization, CQA analytics, and patient-centric product development can ensure the safety and efficacy of your biotherapeutic.
De-risks Your Monoclonal Antibody Scale-Up Process
7/20/2023

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.
Clear MRSA Infections At Single Low Doses
1/4/2024

Multidrug-resistant bacteria are rendering antibiotics ineffective. Review preclinical results of a potent macrocycle derivative and why collaboration is crucial to transition discoveries into treatments.

More Bioprocessing White Papers

BIOPROCESSING APP NOTES & CASE STUDIES

More Bioprocessing App Notes & Case Studies

BIOPROCESS ONLINE CONTENT COLLECTIONS

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This collection of articles, produced through a partnership between MilliporeSigma and Bioprocess Online, highlights the need for ongoing investment in resilient biomanufacturing capacity and supply chains to ensure the reliable delivery of health technologies like vaccines, even during crisis conditions.