04.09.24 -- A Quality-Led Approach To Drug Production Facility Design

It is important to develop robust, reliable processes to safeguard APIs. Explore the best practices to provide patients with the highest quality treatment that meets their therapeutic requirements.

Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of Critical Quality Attributes (CQAs), and performing design verification 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.

The formulation and spray drying process can help manufacture a stable, highly respirable powder and deliver products that require a high drug load, a biologic, or rapid onset therapeutic.

Explore best practices that serve as a guideline for commonly encountered data modeling challenges and how life sciences manufacturers can overcome them by leveraging an Industrial DataOps solution.

It is crucial for models to not only detect toxic drugs but also to avoid erroneously identifying safe drugs as harmful. Learn about the importance of specificity in the early stages of drug development.

Learn about the rising demand for cleanrooms in the biopharmaceutical industry, factors driving cleanroom design, building in flexibility, the role of critical path assessments, and more.

As part of MSAT, in silico approaches such as mechanistic modeling can be used to support and facilitate several activities in the production of biopharmaceuticals at all scales.

As we look forward to the future of drug development, a panel comprising industry consultants and early development experts discussed examining new short- and long-term CDMO and supply chain strategies.

Coperion K-Tron volumetric feeders are often used in a simplified gain-in-weight (GIW) application for controlled batch dispensing and weighing of pharmaceutical powders.

Explore two case studies where lung cancer therapies were delivered to the lung by dry powder inhaler in a rat model and evaluated for efficacy, confirming local delivery is a promising route to treat lung cancer.

Potential pharmaceutical products must be rigorously tested to ensure safety, purity, and performance. Discover a hybrid rheometer that offers capabilities beyond the traditional viscometer.

This biopharmaceutical company had to overcome trial master file (TMF) transfer from a previous licensee, staff turnover, and then a resubmission of its NDA.

Examine the methods used to evaluate, design, and implement solvent recovery processes, a crucial way to achieve significant reductions in carbon emissions.