07.25.25 -- Understanding FDA's Draft Guidance: Composition Statements Of Ingredients In Labeling In NDAs And ANDAs

Examine a novel HPLC-UV/MS method for analyzing GLP-1 analogs to address critical challenges in peptide separation, impurity detection, and performance for improved reproducibility.

Proper packing of MabSelect resins is crucial for efficient chromatography. Verified methods ensure stability, optimal flow, and reproducibility across scales using automated tools.

Gain insight about a flexible aseptic processing system that provides modular, semi-automated, and fully automated solutions to meet demands at all stages of development.

Uncover how AST's satisfaction with Germfree's solution led to the acquisition of two additional units, showcasing the project's success and Germfree's expertise in tailored cleanroom solutions.

A pharmaceutical company facing storage space issues decided to outsource its reference samples to Q1 Scientific, a stability storage service provider, resulting in cost savings.

Recognizing what it takes to complete technology transfers effectively and efficiently is crucial to selecting the best partner for your project and product needs.

Watch how a single-use microbial impactor revolutionizes contamination control in robotic filling lines to enhance sterility, efficiency, and compliance in fully automated manufacturing environments.

Comply with the new EU Annex 1 Section 8.28. Here, we describe a typical raised-stopper investigation and demonstrate how to generate scientifically robust data using headspace analysis.

The growing demand for cannabis-infused products provides an opportunity. Explore high shear mixers and how they can be used in a variety of ways to create cannabis-infused products.

When manufacturing mini-tablets, adjusting punch force ratings is crucial to prevent bending or buckling. The Rankine-Gordon formula offers a safer force rating for microtip tooling.

The revised EU GMP Annex 1 mandates a comprehensive Contamination Control Strategy, continuous environmental monitoring, and species-level contaminant identification to ensure compliance.

Effective sterilization is vital in manufacturing. Discover how the Bowie-Dick test ensures vacuum sterilizer performance, safeguards patient safety, and strengthens your sterility assurance program.

Cleanliness can be detected to varying degrees or levels. Learn about methods of detecting and measuring cleanliness in relation to soil quantities.

Is your cleaning validation process aligned with current regulatory expectations? This checklist helps you implement a risk-based approach, focusing resources to effectively mitigate your highest-risk areas.