09.12.24 -- EMA Issues New Draft Guideline: Chemistry Of Active Substances

Discover the exciting developments in continuous manufacturing and how leveraging this innovative technology can help improve manufacturing processes and discover new clinical candidates.

Learn how leveraging Little’s Law to quantify metrics that otherwise would cause confusion and process interruption can help reduce wait times and deliver materials on time and within budget.

Examine the results of a unique comparative study of CCIT, and find a suitable deterministic test method to replace the blue dye test that follows the latest guidelines.

The USP requirements for elastomeric components of container closure systems used for parenteral products are changing. Explore implications for vial, syringe, and cartridge container closure systems.

Laser-based headspace analysis is a non-destructive and rapid method for testing container closure integrity. We demonstrate that headspace analysis is equally as sensitive as helium leak rate testing.

Generating laboratory data requires time, money, and resources. Explore this guide to ensuring laboratory data is secure and available from creation throughout the full mandated retention period.

New higher volume, higher viscosity formulations for subcutaneous injection are being developed as alternatives to traditional intravenous treatment, enabling chronic disease therapy in alternate settings.

Gain insight into the role of vision inspection technologies in ensuring the quality of primary packaging in pharmaceutical manufacturing, common misconceptions when evaluating these systems, and more.

Watch to explore various aspects of environmental monitoring essential for the transfer of materials into controlled areas as well as recent advancements that can facilitate this task.

Review advanced retrosynthetic analysis services and how these tools empower better, more efficient development of innovative small molecule drugs.

Learn about new data on nanotechnology formulations for multiple dose forms and routes of delivery, including oral, long-acting injectables, inhalation, and ophthalmic.

Explore the advantages of 2000 and 3000 L single-use mixing systems and experimental results demonstrating their capacity to deliver high power at large scales and flexibility for use at lower volumes.

Learn about the advantages of an optimal packaging design and the resulting benefits of its implementation to the overall process.

In this study, a system with multi-capillary capabilities was used to analyze etanercept by capillary electrophoresis-sodium dodecyl sulfate (CE-SDS).

Uncover 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.