September 02, 2022
Cover Story
35
9
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.
September 02, 2022
Development
35
9
The projected growth in the biosimilars market will require increased bulk mAb manufacturing.
September 02, 2022
Peer-Reviewed Research
35
9
This article introduces the requirements for a biosimilar license in Brazil and addresses questions about their quality, safety, and efficacy.
September 02, 2022
Upstream Processing
35
9
A predictive modeling approach can offer tighter process control, which can optimize bioreactor output.
September 01, 2022
Downstream Processing
35
9
Scaling up chromatography resins requires a thorough understanding of their intended use.
September 01, 2022
Manufacturing
35
9
Product safety and security are paramount when it comes to container closures.
September 01, 2022
Quality
35
9
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.
September 01, 2022
Analytics
35
9
A holistic view of the product, manufacturing, and ultimate use of the viral vector is required.
September 01, 2022
BioBusiness
35
9
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.
September 01, 2022
Regulatory Beat
35
9
Pharma loses battle to block price negotiations, but implementation faces many challenges.
September 01, 2022
Outsourcing
35
9
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.
September 01, 2022
From the Editor
35
9
More than anything else MonkeyPox and COVID-19 have shown that we are interdependent, no matter what continent you call home.
September 01, 2022
Ask The Expert
35
9
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.
September 01, 2022
From the CEO
35
9
While the cost of certain medicines are alarmingly high, they can be considered a bargain measured against a lifetime of traditional costs.