GUEST COLUMNISTS

• A Snapshot Of What Pfizer's Doing With Teleoperated Robots

  A robotic arm controlled with a virtual reality headset and input devices could aid in complex interventions where automation isn't practical.

• Intensifying Downstream Processing With Magnetic Separation

  A technique used widely in other industries like steel production and wastewater treatment has emerged as rising star within bioprocessing over the last 10 to 15 years.

• Trends In FDA FY 2024 Inspection-Based Warning Letters

  Of the 190 warning letters that the FDA issued to drug and biopharma manufacturers in fiscal year 2024, this article provides a deep dive on trends pertinent to the 111 inspection-based letters. You may be surprised at some of them.

• AI Performance Management In Biologic And Drug Development

  Life cycle maintenance is essential in AI-driven drug development. Regulators recommend continuous updates to AI models to monitor and adjust for data pattern changes.

• Addressing Challenges In Automated Visual Inspection Of Lyophilized Vials

  Manual inspection is inefficient. Automated systems can struggle with the variability of lyo cake structures. Key technological advancements are coming to the forefront to address these issues.

• How To Build Resilience Amid Dynamic Biopharma Vendor Relationships

  The key to effective vendor management lies in understanding how relationships derail in the first place. Here are some common reasons and tips on how to avoid them.

• What FDA Draft Guidance Tells Us About In-Process Control Strategies

  The draft aims to modernize the regulations in 21 CFR 211.110 catching up to progress in the field including advanced manufacturing and analytical technologies.