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.
- How CSL Behring Worked With EMA/FDA To Develop Hemgenix Potency Assays
- 9 Common Tech Transfer Pitfalls To Avoid
- Bacterial Endotoxin Testing, Part 2: Prerequisites & Reagent Preparation
- Temperature & Containment Controls In ADC Manufacturing
- Uncovering Cell Culture Media's Part In Latest Biopharma Trends
- Making Good Decisions When FDA Investigators Come Knocking
- The Path To Producing An Insulin Biosimilar
EDITOR'S DESK
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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.
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.
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.
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?
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
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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
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Product D-Value Studies: A Critical Tool In Sterilization Process Development
Learn what questions to ask when developing a sterilization method and the critical tool that can help guide your decisions.
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Assessing Liquid Transfer Performance With Reliable, Ready-To-Use Reagents11/13/2023
See how specially formulated dye-containing solutions replicate the liquid transfer properties of several commercially available PCR master mixes, making them reliable and ready-to-use reagents for determining liquid transfer performance.
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A Comparative Analysis Of Mixing Characterization Methods7/19/2023
In the bioprocessing industry, there is no single, standard method for measuring mixing performance. Here, we investigate the four most widely used methods for measuring mixing time.
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Buffers And Process Liquids For Biopharmaceutical Production: Considerations For Scale-Up And Outsourcing5/7/2024
For small and midsize biopharmaceutical organizations, outsourcing buffer and process liquid preparation, quality testing, and storage could significantly streamline operations and reduce regulatory risk.
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PEG In LNP Formulations: Addressing Challenges And Seeking Solutions2/8/2024
Polyethylene glycol and similar variants have driven innovative research for therapies. However, the continued use of PEG poses significant drawbacks. Explore those concerns, here.
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Product D-Value Study - Part 2, Heat-Sensitive & Atypical Aqueous Liquids10/5/2022
How can your organization use this critical tool when developing your sterilization process for heat-sensitive products and low F0 cycles?
BIOPROCESSING APP NOTES & CASE STUDIES
BIOPROCESS ONLINE CONTENT COLLECTIONS
![23_10_BPO_MilliporeSigma_VaccineEbook_300x200 23_10_BPO_MilliporeSigma_VaccineEbook_300x200](https://vertassets.blob.core.windows.net/image/05761483/05761483-3d39-4bdf-9887-d08ce424e8cb/23_10_bpo_milliporesigma_vaccineebook_300x200.png)
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.
More Content CollectionsFEATURED PRODUCTS AND SERVICES
ON-DEMAND WEBINARS
- Considerations In Depth Filter Scale-Up
- Developing A Sterilizing Grade Filter For High Concentration Biologics
- Virus Filtration: Regulations And Mechanisms
- Train Biomanufacturing Operators Faster And More Effectively With Blended Learning
- Nanotechnology To Improve The Performance Of Your Small And Large Molecule Medicines
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 07.26.24 -- Navigating ADC Manufacturing Complexity
- 07.25.24 -- Are Regulators Keeping Pace With Advances In Cell Therapy?
- 07.24.24 -- Life Cycle Planning For Drug Product Containment And Delivery
- 07.24.24 -- End-To-End mRNA DS And DP Manufacturing Processes
- 07.23.24 -- Biotech Doesn't Take Vacations