05.18.23 -- Addressing 3 Challenges Of Developing Or Using A New Excipient

Micronization is an incredibly important step of the process of transitioning a compound from initial discovery into the clinic.

Find out what steps you can take to reduce the risk of component shortages in medical devices and for the manufacture of drugs and biologics and the consequences.

A CDMO that can optimize your API synthesis early during technology transfer will reduce the risk of delay or failure. That will also help your molecule run more efficiently in their plant.

Explore the most recent rewrite of the EU Annex 1 document to prevent cross-contamination and subsequent microbial contamination of sterile medicinal products, and the contamination control strategy outlined within.

Start moving toward more efficient record keeping protocols with manufacturing execution systems (MES) software that reduces quality issues, accelerates resolution, and improves operations.

Find out more about the current trends shaping the future of raw materials characterization in bioprocessing, and how you can take advantage of them.

Why the business case for any therapeutic starts with a CMC developability assessment and why it’s important to understand your end game as early as discovery.

Adhering to cGMP guidelines ensures that pharmaceutical companies offer customers a safe, high-quality product and that production will continue uninterrupted, resulting in reduced time-to-market and costs.

Effective precision weighing systems enable users to balance product throughput, product center distance, and standard deviation. Explore the key factors considered in this technology's development and precision weighing methods.

A proper and well-thought-out combination product testing strategy, rooted in applicable guidances in sync with scientifically sound methods, data capture, and reporting and retainment, is critical.

This bulletin describes the benefits of preparing liquid supplements in a multishaft mixer designed for bulk agitation, high-speed solids dispersion, and superior heat transfer.

There was a short time frame of only seven weeks to complete assay optimization and conduct prevalidation studies within the confines of USP<621>.

Understand the advantages of unit/bi-dose nasal delivery technology, application of QbD processes for inhaled product development, and why to outsource inhalation development and manufacturing.

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.

Discover the challenges pharma companies are facing as they switch focus as well as the actions and technologies companies are implementing to help achieve a brighter future for patients.