GUEST COLUMNISTS

• Impurity Control Strategies For Therapeutic Peptides

  Peptides are an important class of molecules placed between small molecules and biomolecules. Synthetic peptide-related impurities can originate from raw materials, manufacturing processes, degradation, and other causes. This article shares perspectives and recommendations discussed at USP's recent 2022 workshop on the topic.

• FDA Seeks Comment On Conducting Remote Regulatory Assessments

  The FDA believes the use of both voluntary and mandatory remote regulatory assessments (RRAs) for all types of FDA-regulated products is in the interest of public health. The document describes the difference between voluntary and mandatory RRAs and shares information about the RRA report. Public comment ends on Sept. 30, 2022.

• Tools & Techniques For Biopharma Root Cause Analysis

  In biopharma, we must provide a complete and thorough record of our thought processes in order to allow a third party to understand how we have arrived at the root cause of a given problem. This article follows a mock case study to demonstrate a progression of tools and techniques to use.

• The Promising Emergence Of Venom-Derived Compounds

  There are 100,000+ venomous animal species, each producing a chemical cocktail of up to 1,000 different components, including peptides, proteins, and non-peptide small molecules. Many in drug development view venom-derived compounds as simple peptides that will be easily digested, limiting their therapeutic potential. This article dispels that myth.

• What’s The Environmental Impact Of Biopharma Continuous Manufacturing? Part I

  One aspect of biopharma continuous manufacturing (BCM) often overlooked is its environmental impact compared to that of a similar batch process. In comparing the two, there is much that needs to be considered. This article is the first in a two-article series and discusses key considerations of both processes and provides a deep-dive into water usage.

• Your 3-Step Process For Innovation In Precision Medicine

  Scientific advances are exciting, but not every discovery translates well into the clinic. Why is that? And how can companies successfully position themselves for market success with their drug discovery efforts? 

• Data: The Near Future Of Regulatory Info Management In Europe

  Data, rather than static documents, is the future of regulatory information management. It also paves the way for information to be shared in different formats as use cases dictate, while still ensuring the consistency of the data. Even though regulators haven’t quite got their ducks in a row yet, they know full well that this is the scenario that everything is pointing toward. So, to prepare for anything less would be unwise.

• Heightened Standards For Satisfying Written Description In Pharma Patents

  In Biogen Intl. v. Mylan, the Federal Circuit invalidated claims in one of Biogen’s patents based on its finding that a claimed dosage limitation was insufficiently described in the disclosure and, thus, failed to meet the written description requirement. Between that case and another recent case, the Federal Circuit is showing heightened scrutiny on this patenting subject.