04.24.25 -- Are Our Current Operational Processes Sustainable For 2025 And Beyond?

Discover an ICH Q10 checklist that provides a global framework for pharmaceutical quality systems to ensure consistent standards from development to commercialization and enhances patient safety.

Choosing the right CDMO is crucial for the success of your pharmaceutical project. Learn how to strike the ideal balance between an organization's technical expertise, facilities, and efficiency.

Investigate the efficiency of disinfectant-neutralizing agents added to culture media in the presence of several commercially available disinfectants.

We share important factors to consider when weighing your contract service provider options. These “Three Cs” can indicate whether a service provider has the capabilities desired by a drug sponsor.

Biomass soft sensors utilize existing measurements from hard sensors to predict biomass levels in real-time. Explore how to enhance your bioprocessing production, decision-making, and efficiency.

Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

Regulatory demands and patient well-being drive the necessity of aseptic techniques. Find out how these procedures, vital to pharmaceutical manufacturing, prevent contamination and ensure drug safety.

A human factors strategy ensures medical products are safe, effective, and compliant by integrating user-focused design early, reducing risks, and optimizing regulatory approval processes.

Gain insights from process developers working with recombinant proteins that cannot be purified with affinity chromatography.

Examine the development of high drug load nanocrystal-based tablets, and how nanocrystals can match the pharmacokinetic performance of ASDs while reducing the overall pill burden.

What are the benefits of using automated product data management and quality management system software solutions in manufacturing?

Should you manage certain operations internally or partner with a trusted external provider? Watch experts discuss the benefits of outsourcing stability, storage, and testing.

Uncover how the various proprietary platforms and in-house expertise fit together to enable a range of comprehensive options that can be adapted to fit development strategies.