BioPharm International, September 2022 Issue

While a variety of innovations have already impacted the drug delivery landscape, improving sustainability and having the ability to make smaller volumes of drug products still require work.

The projected growth in the biosimilars market will require increased bulk mAb manufacturing.

This article introduces the requirements for a biosimilar license in Brazil and addresses questions about their quality, safety, and efficacy.

A predictive modeling approach can offer tighter process control, which can optimize bioreactor output.

Scaling up chromatography resins requires a thorough understanding of their intended use.

Product safety and security are paramount when it comes to container closures.

Change of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.

A holistic view of the product, manufacturing, and ultimate use of the viral vector is required.

The Hatch Waxman safe harbor provision exempts otherwise infringing uses of patented materials if they are in furtherance of a regulatory submission, but the use of patented research tools may fall outside its protection.

Pharma loses battle to block price negotiations, but implementation faces many challenges.

It is important to understand regulatory requirements and study challenges to develop and validate the appropriate methods for a bioanalytical study program at the clinical stage.

More than anything else MonkeyPox and COVID-19 have shown that we are interdependent, no matter what continent you call home.

A process flow diagram can help create an agreed-upon process flow for a third-party standard operating procedure, says Siegfried Schmitt, VP Technical at Parexel.

While the cost of certain medicines are alarmingly high, they can be considered a bargain measured against a lifetime of traditional costs.