Next-Gen Technologies Tackle Drug Delivery Challenges
The complexity of newer biotherapeutic molecules calls for alternative drug delivery strategies.
Trends in Outsourcing of Bioprocess Development
Speed-to-market, capacity, technology development, and increased investment top the list.
Getting a Nose for Vaccines
The intranasal route of administration is showing clinical promise, particularly for COVID-19, but there are multiple hurdles to overcome to ensure successful formulation.
Large-Scale Single-Use Bioreactors Prove Mettle Amid Growing Demand
Large-scale single-use bioreactors prove successful as limits are tested.
Limits and Successes Define Large-Scale SUBs Path
SUB bioreactor performance has had seen its limits and successes.
Designing a Control Strategy for Facilities with Single-Use Systems
Early control architecture decisions can impact a facility’s long-term growth, flexibility, and efficiency.
Increased Data Flow Demands Strategic Management
Establishing a data management strategy in-lab is a first step in generating successful analytical studies.
Public Trust in Medicine Quality as Public Health Challenges Emerge
Public health challenges have highlighted the need for agility in maintaining the quality of medicines.
Bioanalytical Studies Support Biosimilars Approval Pathway
Establishing bioassay studies for biosimilar development is important for supporting regulatory filings.
FDA Moves to Advance Innovative Excipients
A new program will test the safety and suitability of new inactive ingredients to encourage the accelerated adoption of FDA-accepted excipients in drug development.
New Beginnings
Change of roster does not change the goal line. We are all patients first.
The Basics of Aseptic Processing
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about aseptic processing.
