01.11.24 -- How Does The GAMP 5 Second Edition Update Look One Year Later?

Learn how CMOs are navigating the path to net zero by utilizing planet-conscious talent and partners, and also review key considerations for reducing emissions throughout development and manufacturing.

What sustainable manufacturing processes best address Oligonucleotide environmental impact while maintaining scalability?

More than ever, the quality functions in biopharma manufacturing are under pressure due to regulatory and political scrutiny combined with a global market rife with complex quality standards.

Increasing constraints on today’s supply chain from the COVID-19 pandemic mean drug companies must secure strategies that can ensure product delivery in the face of these challenges.

Ethanol and gel-based disinfectants must undergo QC controls to ensure an acceptable bioburden level. Discover a sensitive method for the quantitative rapid detection of contaminants in filterable samples.

Explore why tablet land, the horizontal surface perpendicular to the tablet's periphery, should be designed using a holistic approach. 

Gain insight into the items necessary for accurate feeding as well as the important role that accuracy can play in the end product and process quality of any continuous operation.

An increasing number of poorly soluble APIs are the cornerstone of cutting-edge therapies, necessitating equally complex formulation technologies to maintain or improve solubility and, ultimately, bioavailability.

Achieving high performance with conventional jet mills remains very difficult. Read about a new generation of spiral jet mills meeting specific particle size distribution targets that have been developed.

The global gene therapy market is continuing to grow, but knowledge and expertise for commercialization are limited. Explore the benefits of partnering with a specialized gene therapy CDMO.

Compare and contrast the pros and cons of several cleanroom design and construction methods to determine the most suitable approach for your specific project.

Drug manufacturers seeking alternative methods for a safe and reliable approach to drug delivery should consider blow/fill/seal technology, as it offers several benefits over traditional glass packaging.

Gain valuable insights into the jet milling process and quality by design approach for inhalation drug delivery and their potential applications in drug development.

In this interview, learn how a complete viable and nonviable contamination monitoring solution was created using PMS instrumentation and equipment.