Newsletter | October 4, 2024

10.04.24 -- What To Do When Your Regulatory Findings Need Quality Risk Management Action

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Visit METTLER TOLEDO at Pack Expo!

Stop by booth 2939 to see live music, educational seminars, and demonstrations of product inspection solutions! We’ll showcase many new solutions including two x-ray inspection systems accessible for all budgets, combination inspection systems, metal detection solutions and a vision system integrated with a thermal transfer printer. All systems will be connected to ProdX data management software which is designed to save time and money, and keep data safe. More.

INDUSTRY INSIGHTS

Does My Cleanroom Facility Need A Residue Removal Step?

Explore the challenges presented by the residues left behind by disinfectant solutions in cleanrooms as well as effective strategies for their management.

The Importance Of Container Closure Integrity (CCI) Feasibility Testing

In the CCIT space, one single inspection technology cannot be used for every type of pharmaceutical product. You should always weigh the various factors to determine the ideal inspection methodology.

Emerging Trends And Challenges For Pharmaceutical Production

Anticyclical by tradition, the pharmaceutical industry is one of the sectors that best cope with the difficulties caused by the pandemic. Learn about the growing market, emerging challenges, and more.

Forget Lean Cleanroom Construction, Practice Lean Installation

Lean construction, as a buzzword, gets a lot of play in the cleanroom industry for good reason. It is an idea that got its start with Toyota in the 1950s to maximize efficiency and eliminate waste in production.

Small Is Powerful And Sustained

Advances in sustained-release drug delivery could improve efficiency and consistency in drug release, manifesting real-life advantages for patients in the form of enhanced accessibility and compliance.

Breaking Bad Manufacturing Habits: Attaining Sustainable API Production

Sustainability is a growing issue in the pharmaceutical industry. Review strategies for reducing your carbon footprint and learn how the right CDMO can help drive the sustainable manufacture of APIs.

Diagnose Absorption Risks To Improve Preclinical And Clinical Outcomes

Physiologically based pharmacokinetic modeling is a powerful tool for clinical trial design that can be leveraged alongside early development experiments to reduce costs and accelerate timelines.

The Sponsor's Clinical Development Handbook For Gene Therapy Trials

Gene therapy has existed for decades, but the field is not as mature as it may seem. Here, the author provides essential insights and strategies for overcoming gene therapy development challenges.

Why A Leading Manufacturing Partner Chose NeoTOP Packaging Machines

Learn how a leading CDMO partnered with Körber to quickly deploy a high-speed packaging solution to meet tight production deadlines in the face of a global pandemic.

Enabling Long Lasting Clinical Outcomes In Coronary Stenting

Polyester amides (PEAs) bring several desired and differentiating properties to drug-eluting stent (DES) applications for treating coronary artery disease (CAD).

Ensuring Stability And Safety In Aseptic Fill/Finish Manufacturing

Not all CDMOs are suitably equipped to handle aseptic processing and sterile F/F operations on a clinical and a commercial scale while offering robust safety measures and global reach.

Innovation For Subcutaneous Delivery Of Large-Volume Complex Biologics

Explore the key findings of a new wearable injector clinical trial, including its positive impact on patient experience and the broader benefits of wearable injectors for chronic disease management.

FEATURED EDITORIAL

What To Do When Your Regulatory Findings Need Quality Risk Management Action

More than half of all recent warning letters issued by the FDA include citations for absent or incomplete risk assessments. This article examines what regulators are looking for.

SOLUTIONS

Process Trains For Flexible, Configurable Biopharma Manufacturing Capacity

Drug Delivery Cartridge Forming Lines

Injectable Drug Manufacturing

The Global Leader In Organ-On-A-Chip Technology

Rapid, High-Throughput Assays For IgG Quantification

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