Guest Columns

  1. DSCSA, Blockchain, & The Pharma Supply Chain — Where Do Things Stand? 5/27/2020

    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.

  2. Identifying, Documenting, & Auditing Processes For Quality Management 5/25/2020

    Process results that are predictable and consistent can be achieved more effectively and efficiently when the activities are considered, managed, and understood as interconnected processes that function as a system.

  3. Put Your Continued Process Verification (CPV) Data To Work 5/22/2020

    Though the FDA’s process validation guidance has been in place for over a decade and other regulatory agencies (EMA, WHO, PIC/S) continue to accept the continuous process verification (CPV) concept, adoption has been slowed by the data governance, analytical capability, and technology challenges.

  4. Cell And Gene Therapy Bioprocessing: Hiring And Capacity Crunch On The Horizon 5/21/2020

    With a very healthy R&D pipeline of cell and gene therapies, we can expect multiple blockbuster products and various “orphan” niche products to be launched annually in coming years. As a result, the industry is heading for a capacity crunch.

  5. Cleaning Up The Systems Mess: A Phased Approach To Implementing Real Automation And EBRS 5/20/2020

    The biopharma industry uses the most sophisticated microbiological and genomic technology, and we experience waves of advancements in therapies driven by our computing and communications technology. So, why are we still drowning in 100-page paper batch records, books of SOPs on the plant floor, and paper documents being handled by operators?

  6. Can Biosimilars Be The Bridge To More Widespread Continuous Bioprocessing? 5/19/2020

    This article will examine the relationship between improved continuous manufacturing (CM) and biosimilar development, paying particular attention to the reasons why biosimilars are especially promising candidates for CM development and innovation.

  7. Working With Two Consultants On One QMS Overhaul: What Could Go Wrong? 5/18/2020

    Some companies in the life sciences mistakenly assume that if they hire multiple consulting firms to establish, manage, or overhaul a quality management system, it will inevitably result in an automatic licensure of their new blockbuster product at a low service cost. This article will discuss just such a scenario. 

  8. Should You List All Manufacturing Facilities In Your Drug Application? A Question Of Regulatory Ethics 5/15/2020

    In this second installment of a two-part article, we will review the importance of listing all appropriate manufacturing facilities in the drug substance section of a drug application and discuss the role of regulatory professionals in ensuring that the necessary information is included in the application.

  9. Samsung Bioepis CEO: A COVID-19 Call To Action 5/14/2020

    There is a lot of speculation around exactly just how this pandemic will impact our own FDA timelines. But whether a drug will get approved several months later than expected is not the core issue on which we should be focused — it’s the consequences these delays or changes in our day-to-day work might have for people with severe and chronic illnesses.

  10. Navigating The FDA’s Emergency Use Authorization Process 5/14/2020

    The FDA has been authorized to grant Emergency Use Authorizations for any medical countermeasure that facilitates the diagnosis, prevention, or treatment of SARS-CoV-2. This will impact both internal manufacturing and the CDMOs that drug sponsors employ. Here’s a detailed look at the ramifications and the details.