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Drug Labeling: 3 Pitfalls To Avoid And 8 Best Practices To Follow

You may have processes in place to prevent drug labeling errors, but they can still occur. Here are three common pitfalls and the eight best practices you should be employing to make sure they don't happen.

Is Your Bioprocess Facility Truly ‘State-Of-The-Art?’
FDA Issues Draft Guidance On Remote Interactive Evaluations Of Drug Manufacturing And Bioresearch Monitoring Facilities

EDITOR'S DESK

ADC Advancements Allowing For Higher DAR
A 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.

How Linker Technology Is Driving ADC Development

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.

Tech-Heavy Drug Discovery Yields Deep Pipeline

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.

Engineering Antibodies In A Box?

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.

Why RNA Is Good For Business

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

Designing Facility Monitoring Systems For Cleanrooms
Let's examine the features and advantages of facility monitoring systems, system architecture considerations, and overall system considerations.
Release Testing Of AAV Gene Therapies For Clinical Trials
Adeno-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.
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.
Your 6 Priority Areas For A Successful 2024
As 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.
A Brief Guide For Vaccine Companies Working Toward FDA Approval For the First Time
This 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.
6 PEG Alternatives You Should Be Thinking About
PEGylation 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.
Emerging Trends & Technologies In Anti-Counterfeit Pharmaceutical Packaging
Counterfeit 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?
Achieving Flexibility In RNA Drug Manufacturing With Microfluidics
RNA 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.

BIOPROCESSING WHITE PAPERS

Standardized, Modularized Manufacturing Strategies
Explore the potential benefits a modularized and standardized single-use manifold design could provide your organization.

Assessing End-To-End Drug Development Partnerships
1/24/2022

As drug development becomes increasingly expensive and complex, pharma companies are relying on CDMOs. Consider the opportunities and challenges of end-to-end arrangements.
Regulatory Considerations For Alternative Microbial Methods
2/28/2022

We discuss regulatory expectations for the incorporation of alternative methods to prevent, remove, and detect contaminants focusing on comparability and strategies for easier substitution of current methods.
Balancing Cost Efficiencies In The Drug Development Process
1/24/2022

Cost efficiencies and expertise again go hand in hand, with companies often outsourcing or partnering primarily to gain access to manufacturing know-how.
The Dynamic Regulatory Environment Of Drug-Device Combination Products
11/29/2022

Examine the dynamic regulatory environment of drug-device combination products as well as concrete steps to take to navigate regulatory complexities and decrease time to market.
Reducing Risk During CAR T Cell Therapy Development And Manufacture
1/26/2022

It is essential to identify potential areas for optimization early in CAR T cell therapy development—particularly with respect to equipment, reagents, and analytics.

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.