Defining a Holistic Approach to mAb Purification Processes
Understanding the process and product goals is just the first step to a holistic approach to process development.
Viral Clearance Testing Increasingly Challenged by New Biologic Modalities
New biologic modalities, such as cell and gene therapies, pose increasing difficulties in viral clearance testing methods.
360 Degrees of Cleanliness
Help prevent contamination in a facility by zone.
Assessing Manufacturing Process Robustness
A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.
Preparing for the Unexpected: E&L Studies in Biopharma
New challenges in extractable and leachable studies for cell and gene therapy products.
Track-and-Trace Progress Benefits Supply-Chain Security Efforts
The industry has made great strides in implementing serialization technologies, while technology developers are enabling more open access to real-time transportation data.
Balancing Pressing Priorities
CMOs and CDMOs adjust business processes as demand for COVID-19 treatments and non-pandemic related therapies puts pressure on the bio/pharma industry.
White House Promotes US Drug Manufacturing to Secure Access to Vital Medicines
HHS is tasked with establishing a public-private consortium for advanced domestic pharmaceutical production.
Avoiding Delays on the Road to Normalcy
Vaccines define the path to putting pandemic restrictions and pain in the rear-view mirror.
The Value of FDA 483s and Warning Letters
Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel.
