Guest Columns

  1. 3D Printing For Pharmaceuticals & Medical Devices: A Primer With Risk Considerations 1/28/2022

    Implementation of single-use technologies for pharmaceutical and medical device manufacturing has introduced advantages in terms of design, sterility assurance, and a reduction in energy usage. 3D printing can deliver precise measurements to medical production facilities. This article describes the 3D printing process, risk considerations, and limitations — but the future is bright.

  2. Be Better Prepared With Your New Continuous Manufacturing Perfusion System Than We Were 1/26/2022

    This author tells a story about working at a small biotech startup that deployed a new perfusion system. He shares the team's challenges and lessons learned with the experience.

  3. The 4 Trends Affecting Blockbuster Drug Status 1/25/2022

    Although the billion-dollar mark will remain one of the principal benchmarks to define the success of pharmaceutical products, new indicators are emerging. This article looks at the drugs identified in Clarivate's Drugs to Watch series from 2015 and 2016, analyzing the trends and challenges that occurred over the past five years. The analysis identified these 4 key trends.

  4. Troubleshooting A Failed Process Performance Qualification: Lessons Learned 1/24/2022

    Recently, this author was preparing for a process performance qualification (PPQ) for a fc fusion protein that had a small number of clinical lots. The PPQ didn’t go as planned; quality attributes dropped to unacceptable levels and the cell health declined. This is the story of how the team identified the problem and then fixed it.

  5. Proposed Solutions For Cell & Gene Therapy Validation Challenges 1/21/2022

    As more experience and knowledge are gained on cell and gene therapy manufacturing processes, some challenges will be resolved and others will be identified. This article delves into challenges and proposed solutions for manufacturing process validation, designing PPQs for autologous cell therapy, and analytical method validation.

  6. Plot A Successful Course: Critical Risk Assessments With CDMOs 1/20/2022

    The landscape of risk management between biopharma companies and their CDMOs looks nothing like those where direct oversight is the operating paradigm. This article shares recommendations on how to find common ground when assessing risks as well as tips to facilitate trust.

  7. FDA Releases Draft Guidance On Use Of Real-World Evidence For Drug & Biological Products 1/19/2022

    The FDA has issued new draft guidance in its latest effort to clarify its expectations regarding the integration of real-world data (RWD) and real-world evidence (RWE) into clinical research, product approvals, and post-approval monitoring of drugs. You can submit public comments until March 3, 2022.

  8. Medtech At A Turning Point: The 5 Areas To Address In 2022 1/19/2022

    From 2020 to 2021, the medtech industry's revenues grew and the industry entered a period of recovery and renewal. However, as 2022 begins and we look to a future where COVID-19 becomes endemic, the medtech business model must evolve in these 5 key areas.

  9. Sex Matters… In Preclinical Drug Development? 1/18/2022

    In safety pharmacology studies investigating short-term side effects on physiological functions, the scientist is obliged to “consider” sex in the study design of animal models. This article also shares the differences in anxiety and depression in human males and females.

  10. Aiming To Solve The 3 Key Challenges Of CAR T-Cell Manufacturing 1/18/2022

    These authors share their best practices for solving the three key challenges of CAR T-cell manufacturing (supply constraints, scalability issues, and storage and logistics challenges) using their experiences with Epstein Barr Virus (EBV) T cells.