Biopharmaceutical companies calling their facilities "state-of-the-art" should use the latest, most cutting-edge technologies and techniques. Many say they do that but don't really.
- mRNA Vaccine Platforms With Combined Therapeutics' Dr. Romain Micol
- Release Testing Of AAV Gene Therapies For Clinical Trials
- How Can Digital Twins Get Us Closer To Pharma 4.0?
- Your 6 Priority Areas For A Successful 2024
- Biotech Dealmaking With Regeneron's Nouhad Husseini
- A Brief Guide For Vaccine Companies Working Toward FDA Approval For the First Time
- 6 PEG Alternatives You Should Be Thinking About
EDITOR'S DESK
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![Antibody-drug-conjugated-with-cytotoxic-payload-Gettyimages-1410189307]( "ADC Advancements Allowing For Higher DAR")
ADC Advancements Allowing For Higher DARA high drug-antibody-ratio (DAR) used to mean higher off-target toxicity for ADCs. Now, thanks to improvements in linker technology and antibody targeting, higher DARs can allow for improved efficacy.
If you’re still not excited about antibody drug conjugates (ADCs), “there’s an issue with you.” That’s the passionate, bullish sentiment (jokingly) held by Dr. Joe Daccache, project leader at DeciBio. Here, Daccache explains how innovations in linker technology are advancing the field of ADCs.
Recursion Cofounder and CEO, Chris Gibson, Ph.D. is creating a map of human biology comparable to Google’s ongoing effort to map every street on the planet. He shared why that's so important, and how it's informing Recursion's rapid drug discovery efforts.
Machines aren’t smart enough to engineer optimal, disease-specific antibodies without data that’s properly generated, captured, and structured. That’s why LabGenius Founder Dr. James Field says the key to success is neither human-derived data, nor machine-enabled design. It’s the organizational engineering feat of bringing the two together.
Early last year, Nutcracker Therapeutics landed a $170 million Series C to further its work developing an RNA drug development platform. Learn how scientist-turned Chief Business Officer Geoff Nosrati is lifting the company above the cacophony of companies rallying around the therapeutic potential of RNA.
GUEST COLUMNISTS
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![iStock-1209892070-lab-cell-gene-microscope]( "Release Testing Of AAV Gene Therapies For Clinical Trials")
Release Testing Of AAV Gene Therapies For Clinical TrialsAdeno-associated virus (AAV) gene therapies that are designed to deliver a therapeutic transgene to patients are complex products that can be challenging to manufacture. Because of their complexity, a variety of analytical methods are required to ensure that these viral vectors are of high quality and purity, will function as intended, and have batch-to-batch consistency.
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![GettyImages-904420272]( "How Can Digital Twins Get Us Closer To Pharma 4.0?")
How Can Digital Twins Get Us Closer To Pharma 4.0?Digital twins — virtual representations of physical and conceptual assets, processes, or systems — offer a seamless bridge between the present challenges and the vision of Pharma 4.0.
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![High priority-GettyImages-480267858]( "Your 6 Priority Areas For A Successful 2024")
Your 6 Priority Areas For A Successful 2024As we approach the end of 2023, and pharma/biotech companies finesse their road maps for 2024, this article assesses the six priorities vying for attention.
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![Vaccine]( "A Brief Guide For Vaccine Companies Working Toward FDA Approval For the First Time")
A Brief Guide For Vaccine Companies Working Toward FDA Approval For the First TimeThis article outlines best practices for expediting the FDA approval process while maintaining safety and efficacy standards. Tips are related to vaccine R&D, understanding the Emergency Use Authorization (EUA), post-approval surveillance and monitoring, and more.
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![T Cell GettyImages-538032878]( "6 PEG Alternatives You Should Be Thinking About")
6 PEG Alternatives You Should Be Thinking AboutPEGylation is a common way to minimize off-target effects and general toxicity, but it also poses life-threatening risks because it prolongs the drug's time in the bloodstream. Scientists are exploring these alternatives to combat the risk.
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![pharmaceutical track and trace-GettyImages-1492610021]( "Emerging Trends & Technologies In Anti-Counterfeit Pharmaceutical Packaging")
Emerging Trends & Technologies In Anti-Counterfeit Pharmaceutical PackagingCounterfeit medicines are rising at an alarming rate, with data showing that nearly 6,500 pharmaceutical crime incidents were recorded in 2021, ranging from innovator drugs to generics, and from antimalarials to blood pressure medicine to vaccines. What packaging and labeling strategies are pharma/biotech companies using to tackle this?
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![GettyImages-1482996610]( "Achieving Flexibility In RNA Drug Manufacturing With Microfluidics")
Achieving Flexibility In RNA Drug Manufacturing With MicrofluidicsRNA manufacturers need flexible processes and technology. They need to manufacture high-quality RNA in small quantities and scale up. Modular, and more specifically, modular microfluidics equipment makes that easier. This discussion takes stock of the current state of modular equipment for RNA manufacturing.
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![GMP-Good manufacturing practices-GettyImages-1219617557]( "Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs")
Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing NeedsAppropriate manufacturing and timely delivery of investigational products are essential for the successful execution of clinical trials. This article shares best practices working with CDMOs as well as phase-appropriate GMP of the clinical supply.
BIOPROCESSING WHITE PAPERS
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![Scientists Working On Computer GettyImages-1090255692]( "Single-Use Multi-Layer Film Delivers Comparable Cell Growth Performance To Glass")
Single-Use Multi-Layer Film Delivers Comparable Cell Growth Performance To GlassExplore the findings of studies analyzing the performance of upstream bioprocessing with Ultimus® film, a single-use, multi-layer film with a fluid contact layer free of Irgafos® 168.
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Pharma And Biotech: How Labs Achieve Data Integrity10/13/2022
Learn from an industry expert how important it is for companies to be compliant with data integrity and to ensure the trustworthiness and reliability of electronic records.
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Bench To Bedside: A Scalable End-To-End Solution For AAV Production8/30/2022
How to efficiently translate bench-scale processes to commercial GMP manufacturing to produce viral vectors at the scale needed to meet dosage requirements.
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ICH And USP <1220>: Implementing A Quality By Design Analytical Framework2/9/2022
The ICH and the USP are currently finalizing draft guidelines that describe a new paradigm for analytical development based on the QbD approach used for development.
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Solving Cost And Supply Challenges In Biopharma Downstream Processing7/20/2023
In response to the growing demand for monoclonal antibodies, researchers are looking at different areas of the downstream process where they can improve efficiency and scalability.
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Liposomal And Nanoparticle Technology4/20/2022
Specializing in oncology, anti-infective and complex formulations, the facility provides end-to-end services from development through to commercial manufacture of sterile dosage forms.
BIOPROCESSING APP NOTES & CASE STUDIES
- Magnetic Bead Removal Using Microcarrier And Cell Separation System
- Illustrating A Successful Small Biotech-CDMO Relationship
- High Efficiency Single Cell Cloning Of iPSCs Using Combination Of MatriClone And VIPS
- Take Advantage Of Single-Use Technologies For Microbial Processes
- ACQUITY And XBridge Premier Protein SEC 250 Å Columns: A New Benchmark In Inert SEC Column Design
BIOPROCESS ONLINE CONTENT COLLECTIONS
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.
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NEWSLETTER ARCHIVE
- 12.06.23 -- 7 Improvements In Clinical Supply Chain Management Your CFO Will Love
- 12.05.23 -- Meet Pharma's Future By Embracing GMP Manufacturing
- 12.05.23 -- The Future Of Lipid Nanoparticles In Developing Cell And Gene Therapy
- 12.04.23 -- New Episodes: RNA Delivery Business, Gene Therapy Deals, Steve Gorlin's Golden Rules, and more.
- 12.04.23 -- Single-Use Bioreactors Gain Popularity Worldwide