GUEST COLUMNISTS

• What Managing Personal SARS-CoV-2 Risks Can Teach Us About Managing Pharma Risks

  This article describes how the basic principles of managing personal risks of being infected by a respiratory virus can be used to manage risks for developing and manufacturing pharmaceuticals. The goal is to elucidate the basic principles of understanding, managing, and communicating a wide variety of risks from the trivially simple to the very complex.

• An Introduction To Liposome Processing For Drug Delivery

  On Monday, Bioprocess With The Bozenhardts will take a deep dive into the return of the liposome. In the meantime, this column digs into why the liposome's biocompatibility and well-understood chemistry of encapsulation of a wide variety of APIs make it a compelling delivery mechanism.

• After COVID-19: Time To Rethink, Redesign, & Reprioritize Everything

  As we navigate the uncertainty ahead, two things are certain: 1) We will get through this, and (2) the post COVID-19 environment will be very different — but will it be better?

• Introduction To The ASTM E3106 “Standard Guide To Science-Based And Risk-Based Cleaning Process Development and Validation”

  The new ASTM E3106 focuses much more attention on applying science and risk at the risk identification and risk analysis stages, including cleaning process development, than has been done in the past.

• Are You Ready? FDA’s Transition From Computer System Validation To Computer Software Assurance

  The FDA is preparing to release new guidance, "Computer Software Assurance for Manufacturing, Operations and Quality Systems Software," in late 2020. This new guidance will provide guidelines for streamlining documentation with an emphasis on critical thinking, risk management, patient and product safety, data integrity, and quality assurance.

• Knowledge Management — Opportunities & Challenges For Legacy Drug Products

  This article will explore specific challenges of managing knowledge in a legacy manufacturing environment and propose viable, practical solutions that have been found to be effective. These solutions allow practitioners to increase product and process understanding as well as performance.

• 2 (Major) Impediments To Faster Biopharma Product Development

  As pharma products have become more complicated, companies have become bogged down in accomplishing their mission of launching new products because of complex regulatory requirements, convoluted management approaches, and inefficient resources and methods that add time and cost to moving new products from research to patients.

• DSCSA, Blockchain, & The Pharma Supply Chain — Where Do Things Stand?

  As the requirements for serialization and track & trace become more challenging to implement as we approach 2023, blockchain, by providing data integrity throughout the supply chain, becomes a more attractive solution to reducing the probability of errors occurring.