Expanding the Emerging Therapeutic Horizon
New therapeutic opportunities are offering significant promise for the bio/pharma industry and patients.
Challenges of Expanding CAR-T Cell Therapy into Solid Tumors
The development of CAR-T therapies for solid tumor cancers presents a myriad of challenges.
Contextualizing Single-Use Waste
It is crucial to examine the context in which single-use waste is viewed.
Overcoming Harvesting Challenges for Adherent Cell-Culture Processes
Optimization strategies that leverage advanced technologies are essential for maximizing yield and quality.
Data Integrity Pitfalls
Avoiding missteps in data integrity is contingent on the development of a holistic data integrity approach.
Optimizing the Manufacture of Emerging Therapies
Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.
FDA and Industry Prepare for End to COVID-19 Emergency
FDA is encouraging sponsors to conduct studies and file applications for full approval of products authorized by Emergency Use Authorizations.
Measuring Quality in a Culture
The concept of quality culture and how to enforce it are being debated by regulators and industry, says Siegfried Schmitt, vice president, Technical at Parexel.
The Smart Benefit of Digital Systems in Preclinical Studies
Preclinical studies specifically benefit from the “smart” drug development trend through deeper data access and analysis.
Springing Forward!
INTERPHEX was back in full swing with Keynote sessions highlighting cutting-edge technologies that are setting the stage for the bio/pharma industry’s future.
Young Pups and Leopards
The engine that drives pharmaceuticals forward, its workforce, is now very low on fuel.
