Exploring Innovative Means for Biologics Delivery
Alternative delivery methods for biologics continues to be explored that offer less invasive, less painful administration.
Extractables Protocol for Single-Use Disc-Stack Separators
This case study describes how the risk assessment of the first-to-market single-use disc-stack centrifuge was conducted.
Biobetter Development
Weighing development costs/resources and performance benefits is essential.
Advances in Filtration Technology
Collaboration between technology providers and biopharma manufacturers are enabling both evolutionary and novel developments.
Considering Process Scaling for Monoclonal Antibodies During Early Phase Development
Platform processes and effective risk assessments help overcome time and cost challenges.
Meeting Adventitious Agent Testing Needs for Complex Modalities
Viral vectors and other complex biologic modalities require more specificity and higher sensitivity to detect and distinguish contaminants.
Leveraging Bioanalytical Studies Advancements
As the field of bioanalytical testing evolves, it is important for drug developers to stay at the forefront of the advancements to ensure they remain competitive.
Responding to Mpox
A coordinated and international response is needed to help control the latest mpox outbreak in Africa.
Keeping Audit and Inspection Programs Current
Updating your audits and inspections program ensures inspection preparedness, says Siegfried Schmitt, vice president, Technical at Parexel.