By Tracy TreDenick-Fricke, BioTechLogic, Head of Regulatory and Quality, and Senior Consultant Most of us now understand that SARS-CoV-2 (the cause of COVID-19) is often transmitted via respiratory droplets. However, SARS-CoV-2 is also spread by contaminated contact surfaces and hands, but all contact surfaces are not created equally. A chart published by the Journal of Hospital Infection is quite helpful for understanding the persistence of the virus on various surfaces.
Read moreResources
Navigating the European Union’s (EU) Drug Device Combination Product Regulatory Changes
WHITE PAPER Navigating the European Union’s (EU) Drug Device Combination Product Regulatory Changes The European therapeutics market has been working to manage the upheaval...
Process Validation for Expedited Approval Drugs
WHITE PAPER Process Validation and Regulatory Review in the Age of Expedited Approval Drugs This paper explores those dynamics and offers some revised approach suggestions....
Cell Therapies – Overcoming Challenges Within the Regulatory Framework
WHITE PAPER Cell Therapies Come of Age: Overcoming Challenges Within the Regulatory Framework Within the cell therapy arena, regulators, the medical community and industry...
mAbs and Their Therapeutic Evolution
WHITE PAPER mAbs and Their Therapeutic Evolution By Tracy TreDenick, Head of Regulatory and Quality, and Senior Consultant Monoclonal antibodies (mAbs) elegant specificity...
Key Considerations in Gene Therapy Manufacturing for Commercialization
eBook Key Considerations in Gene Therapy Manufacturing for Commercialization “The regulatory landscape for gene therapies is as transforming as the curative nature of a...
Recent Posts
- Top 25 Biotech Companies of 2024
- The EU Clinical Trials Regulation – Experiences from the First 18 Months
- CMC Expertise Accelerating Biologics Development for 20 Years and Counting
- Strengthening Your Gene Therapy Process Control Strategy
- Designing a Gene Therapy CMC Architecture for the Full Product Lifecycle