Posts categorized as“Biotech”

Gary Skarja

BioProcessing 4.0: Building the Future of Bioprocessing

Bioprocessing (also known as biologics manufacturing) is a branch of the medical industry where bacteria, cells or enzymes are used to create and isolate biopharmaceutical products. This is broadly accomplished in multiple upstream (e.g., cell culture, cultivation and harvesting) and downstream (e.g., filtration, centrifugation and chromatography) unit operations in concert with process analytical technology.

Zhamak Abdi

Using Systems Engineering to Improve Technology Transfer for Early-Stage Biotech Companies

As an early-stage venture grows the process of technology transfer from an academic research laboratory to industry and/or scale-up setting can be a significant challenge for early-stage biotech companies. Transferring novel biotech platforms from academia into commercially relevant products requires a comprehensive mechanism that addresses funding, regulatory compliance, intellectual property, commercialization, competition, and other key […]

Khaled Youssef

The Role of Lipid Nanoparticles in Vaccine Production

The recent COVID-19 pandemic has been a reminder of how effective vaccines are for protecting public health and saving healthcare system resources. The world was brought to its knees at the beginning of the pandemic with countless heartbreaking deaths, but this tragedy catalyzed the accelerated development of different vaccines through collaboration between governments, pharmaceutical companies, […]

Lorenzo Gutierrez

7 “ZOMBIE” Microfluidic Cartridge Early Indicators

Recommendations to Avoid Non-Functional Cartridges The popular Netflix series “The Walking Dead” is all about “Zombies” – people that look normal but lack the ability to function as normal. In microfluidics, there are cartridges that seem perfectly normal and functional but are not due to internal defects. They are “the walking dead“ or “Zombie cartridges” destined […]

Joris van der Heijden

A Guide to Lean and Agile Medical Device Product Development

The success of development programs in the medical device and equipment industry almost always relies on hitting technical milestones that coincide with internal or external fundraising efforts. Especially early in the program, it is critical to hit technical milestones in a cost-sensitive and timely manner. This will eventually determine if a program has legs or […]

Susan Bantroch

Assay Verification in POC Medical Devices

Interference Testing, Strategy, and Detection Case Study The importance of performing assay verification BEFORE incorporation into a medical device can not be overstated. Countless hours and dollars can be wasted designing the perfect device if the detection assay fails in the field. Successful Point-of-Care (POC) medical devices increasingly rely on new and innovative analyte detection […]

Nick Allan

Autonomous Clinical Chemistry Assay Design Considerations to Mitigate Interference

This review highlights how designing Autonomous Clinical Chemistry Assay diagnostic products with kinetic read outs helps mitigate challenges with interference that are especially relevant in point of care diagnostics (POCD). Topics covered include Kinetic Assay Versus Endpoint Assay, Point of Care, Hook Effect, Clinical Laboratories Standards Institute, and real time laboratory diagnostics.

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