01.09.25 -- FDA Issues New Guidance: Nonclinical Safety Assessment Of Oligonucleotide-Based Therapeutics

How do you choose the right X-ray inspection system? This guide outlines everything you need to know to select a system to meet your detection goals in a way that maximizes ROI and OEE.

Some drugs violate multiple Ro5 elements but remain developable, while some molecules adhere strictly to the Ro5, but their properties are not conducive to development.

Realize the value of connectivity, and more specifically, the value of the information provided by checkweighing, metal detection, vision inspection, and X-ray inspection.

Explore core elements of the ISA-95 specification and how life sciences manufacturers can apply them within an integration solution designed for industrial data modeling, delivery, and governance.

This paper highlights how the roller compaction process not only enhances efficiency but also improves the scalability of solid oral dosage production, supporting rapid development for regulatory approval.

Review the optimization of the manufacturing process of a pharmaceutical intermediate, and discover how yield can be improved substantially via suitable reaction engineering.

A CDMO that has expertise and resources in softgel formulation can help companies address stability issues, improve drug bioavailability, or ensure compliance with regulations.

Process replication at a small scale, verification runs, and satellite runs conducted in parallel to manufacturing are valuable risk mitigation tools that maximize efficiency and product quality.

How can your organization use this critical tool when developing your sterilization process for heat-sensitive products and low F0 cycles?

Learn how Germfree designed and installed a mobile cGMP cleanroom on a 53′ tractor-trailer chassis to provide a flexible and efficient cleanroom solution tailored to the company’s needs.

Explore strategies for accommodating the ever-increasing upstream titers and volumes to prevent downstream purification from becoming a bottleneck.