Newsletter | February 27, 2025

02.27.25 -- A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices

SPONSOR

Webinar: Optimizing Human Factors Testing: Engaging End-Users in Medical Device Development

Integrating human factors testing in healthcare is crucial for medical device safety and effectiveness. This presentation highlights challenges in real-world testing, emphasizing user comfort and realistic environments to ensure accurate feedback. It covers strategies for optimizing recruitment, testing, and participant engagement while fostering a supportive atmosphere. Click here to learn more.

INDUSTRY INSIGHTS

Guide To Product Inspection Systems In The Pharmaceutical Industry

Uncover the critical role of inspection systems, specifically metal detectors, X-ray systems, and checkweighers, in pharmaceutical manufacturing.

Visually Clean May Not Be Enough

Explore how to enhance product quality and safety in cosmetics manufacturing by standardizing cleaning procedures and emphasizing strict adherence to protocols.

The Role Of IV Bag Inspection In Drug Manufacturing

Advanced IV bag inspection technologies ensure patient safety and regulatory compliance in drug manufacturing. Gain insights about automated leak detection and quality control innovations.

Analytical Services: Risk Management In PFS Components Selection

Choosing the right containers and materials is critical. Two risk-based test methodologies help to select the optimum closure materials and correct syringe silicone level at the early phase of drug development.

Integrated Strategies For Achieving Regulatory Milestones Faster

Learn how an innovative formulation platform reduced development timelines and allowed a sponsor to find the optimal nafamostat formulation without adding unnecessary delays.

Evolving Containment In Pharma Manufacturing Facilities

Here, we characterize the new production directions in pharmacy and describe the flexible equipment to improve pharma efficiency, purity, and production safety in the coming decade.

Anticipating The Top Market Access Trends Globally For 2025

Navigate the shifting healthcare landscape that lies ahead by reviewing policy changes, market access trends, and strategies for ensuring patient access to innovative therapies.

Airborne Particle Sampling Techniques

ISO 14644-21:2023 is a new standard for airborne particle sampling. Listen to Marc Machauer and Mark Hallworth as they discuss the standard while providing insights into its development.

Simultaneous Spray Drying: Dry Powder Inhaler Combination Formulations

The simultaneous spray drying of multiple ingredients is a powerful technique for making inhaled products with multiple actives. Examine how novel techniques can make these products a reality.

Part 1: The Challenges And Opportunities Of Real-World Evidence

Discover how the FDA's Real-World Evidence framework bridges the gap to help integrate real-world data into drug approval, improving efficiency while ensuring data reliability and regulatory compliance.

A Human-Relevant Model Of The Liver Sinusoid

This organ-on-a-chip model minimizes drug absorption while maintaining the essential architecture. Gain insights into the specifications of this product engineered to model the human liver.

Digital And AI Solutions For Life Science Companies

Explore how life sciences solutions integrate advanced technologies and AI to accelerate drug discovery and streamline workflows for innovative biopharmaceutical research and development.

Customized Release Through Dispersed Dosage Formats

Typically, dosage format is based on the target product profile: how the developer envisions the product best addressing a clinical indication by maintaining population-wide efficacy.

A Guide To CRO, CMO, And CDMO Partnerships

By partnering with a reputable CDMO, biotech and pharmaceutical companies can leverage their expertise and resources to expedite the development and manufacturing of life-saving medications.

FEATURED EDITORIAL

Minimizing Human Errors In Biopharmaceuticals And Medical Devices

Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Learn how a new approach, relational risk analysis (ReRA), fundamentally changes the way risks are analyzed.

SOLUTIONS

Oral Solid Dose Manufacturing

An Innovative Platform For The Delivery Of RNA Therapeutics

Future-Proof Your Lab With The Latest Technologies

Small, Simple-To-Use Package For Delivering High-Viscosity Formulations

Quickly Set Up A Zone For Efficient Cleanroom Monitoring

Unlock Pharmaceutical Success: From Idea To Reality

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