Leap Year
Revolutionary therapies restructure pharmaceutical manufacturing.
New Therapies Cry Out for New Skills
There are positive indications for future growth.
Right the First Time: Bioreactor Scale and Design Translation
The authors give an overview of scaling approaches and present good scaling practices for the biopharma industry.
From Vaccines to Oncology and Beyond: Tracking mRNA’s Progress
The success of mRNA-based vaccines paves the way for mRNA in oncology and beyond.
The Pros and Cons of Adherent Versus Suspension Cell Culture
Both adherent and suspension cell culture approaches have their pros and cons, which must be considered for process development.
Navigating Challenges in Cell Therapy Potency Assays
Developing cell-based potency assays for cell therapies requires meticulous coordination.
Selecting Chromatography Resins for Bispecific Antibody Purification
Product and process understanding are essential to effective resin selection.
Are You Ready for Inspection?
Reviewing regulatory documents, such as 483 forms and Warning Letters, can aid in determining a facility’s inspection readiness, says Siegfried Schmitt, vice president, Technical at Parexel.
Reimbursement Precipitating Shortages
GSI shortages result from how hospitals buy GSI drugs, and the underinvestment in manufacturing operations that follow.
