03.27.24 -- Decoding The FDA's Draft Guidance On Computer Software Assurance For Medical Devices & Bio/Pharma

Because clinical applications for AAV are increasing rapidly, there is a high demand for further increasing yields as well as product quality, particularly for a higher percentage of full capsids in the final product.

Cleanroom systems are purposely designed to simplify implementation of the aseptic manufacturing space that the industry needs to meet future sterile injectable capacity demand.

Explore innovative process intensification strategies and practical applications to increase resin utility, resulting in improvements in costs and time efficiencies in Protein A affinity capture.

Building strong relationships with CDMOs and CROs relies on a solid outsourcing framework. Review three key areas that should be built into your outsourcing framework and agreements.

Learn about formulation development challenges for prefilled syringes as well as considerations for reducing the time it takes to launch safer, more convenient, and cost-effective products for the patient.

Review the efficacy of fast stable pools in generating purified product at an early stage and learn how to accelerate the journey toward first-in-human trials and proof-of-concept studies.

From the digital infrastructure needed to enable a collaborative approach, to the quality systems and analytical methods, effective tech transfer relies on the careful consideration of a variety of factors.

Explore the sources of Β-glucan, its influence on manufacturing and patient safety, and ways to detect and control its amounts in the finished drug product.

Read how host cell proteins can constitute a significant component of a biopharmaceutical drug developer’s overall risk-management strategy.

Downstream processing for biologic drugs often requires harsh chemicals that can damage SUT components. However, a polymer has been identified to handle these rough downstream chemicals.

Review these studies for three monoclonal antibody drug candidates utilizing a panel of small scale, fast, and predictive tests used to evaluate therapeutic antibodies’ developability.

What are the regulatory expectations for sterile filtration throughout product development, how do these feed into the CSS, and how do end-user and supplier responsibilities support Annex 1 compliance?

Scientists are working to discover new and effective ways precision medicine can prevent, diagnose, and treat diseases such as cancer.

Monoclonal antibodies (mAbs) are a rapidly growing group of targeted therapeutics. Gain insight into the importance of optimized bioanalytical assay platforms for mAb development.

Are you looking for ways to reduce bioprocess development time and scale-up? Learn the details behind a high-throughput bioreactor system with the ability to generate high quality, reproducible data.

Investigate the mixing efficiency of a next-generation, single-use mixer providing clients with enhanced functionality and ease of use for critical up- and downstream process liquid preparation.