03.07.25 -- Managing Contamination Risks In The Pharmaceutical And Medical Device Industries Using Relational Risk Analysis

The biopharma industry must shift from data collection to process knowledge, leveraging digital tools to optimize drug development, enhance quality, and streamline tech transfer through digital maturity.

The drug development journey is long, expensive, resource-straining, and risky. Discover how to maximize the value of early-phase material and match your development path to your IND milestones.

In this chapter of the Aqueous Cleaning Handbook, explore the key definitions of aqueous cleaner ingredients, the types of aqueous cleaners, and the application of isoelectric points to cleaning.

Examine key factors that can impact tablet weight uniformity and how it plays an essential role in ensuring pharmaceutical products deliver accurate amounts of key ingredients in a formulation.

Watch to learn how a revolutionary approach to creating amorphous solid dispersions, including those for typical pre- and post-ASD unit operations, is used in the context of real-world examples.

Gain insight into how Emergent BioSolutions upgraded its Winnipeg site with an aseptic filling workcell to improve sterility assurance, product flexibility, and regulatory compliance for CGT manufacturing.

Technological developments have led to growth in the suitability of fermentation. Delve into the impact of the evolution of synthetic biology and supporting technologies on modern fermentation practices.

Considering ergonomics is crucial for optimizing cleaning efficiency and minimizing contamination risks. Explore key ergonomic considerations in cleanroom cleaning, best practices, and more.

See how a CMO with innovative practices and a successful approach to tech transfer and manufacturing processes can help meet project timelines and mitigate risk on the path to market.

Acquire a thorough understanding of environmental monitoring, covering the fundamentals of particle counting, cleanroom designs, regulatory expectations regarding market release, and more. 

Understand the proper timeline for process validation, the tasks required at each stage of the lifecycle, and the importance of linking the URS to each step of validation to ensure complete compliance.

Here, experts share the necessary development and manufacturing considerations for a smooth tech transfer and discuss the questions you should be asking your manufacturer.

Modular cleanrooms are both high-performance machines and durable facility structures. Discover how they are also more cost-effective, reliable, sustainable, and compatible with your manufacturing process.