Quality/GMPs

Feliza Mirasol is the science editor for 

Videos

The importance of proper analysis of HCPs in the biomanufacturing process was discussed by Shawn Li, principal scientist at Merck & Co., known as MSD outside the Unites States and Canada, at AAPS PharmSci 360.

Discussing Proper Analysis of HCPs in Biomanufacturing (AAPS PharmSci 360)

Articles

Aseptic fill/finish of biopharmaceuticals requires an understanding of the structure and limitations of each molecule.

Understanding Molecule Sensitivity in Aseptic Fill/Finish

Dayna Turner is group leader, Science & Technology, at STERIS, Saint Louis, Mo.

Dijana Hadziselimovic is laboratory manager, Technical Services, at STERIS, Saint Louis, Mo.

Paul Lopolito is a technical services specialist at STERIS, Mentor, OH.

Mary Schanne is senior account manager at STERIS, Saint Louis, Mo.

Amy Thanavaro is manager, Science & Technology, at STERIS, Saint Louis, Mo.

Jeff Felker is deputy director, Cleaning Validation SME, Sanofi MSAT Swiftwater, Pa.

In this article, the authors explored the elimination of a water rinse and blow down following the caustic wash step, examining potential safety considerations, the effect on the quality of the cleaning process, and the potential benefit of implementing this change.

Strategic Changes to a Legacy Cleaning Approach Result in a More Sustainable Process

Editor of Pharmaceutical Technology Europe

At CPHI Milan, Zaim Gashi, area sales manager of Steriline, discussed the evolution of aseptic processing equipment to stay compliant with current regulations.

Discussing the Evolution of Aseptic Processing Equipment for Regulatory Compliance (CPHI Milan 2024)

CDER’s Jonathan Chapman, senior policy advisor, and Takeda’s Paulien Groll, head of Compliance Excellence, discussed how companies can be proactive with their CAPA strategies instead of reactive, at the 2024 PDA/FDA Joint Regulatory Conference.

PDA/FDA Joint Regulatory Conference: Proactive CAPA

Viral vectors and other complex biologic modalities require more specificity and higher sensitivity to detect and distinguish contaminants.

Meeting Adventitious Agent Testing Needs for Complex Modalities

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.

Leveraging Bioanalytical Studies Advancements

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss submitting biologics license applications and working with suppliers. 

Submitting Regulatory Applications Connects to Quality

In the second episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice-president, Technical, at Parexel, discuss the quality requirements needed when incorporating AI in bio/pharmaceutical development and manufacturing.

Quality Considerations for Using AI in Bio/Pharma

CGT manufacturing processes need automation as well as standardization, according to Lonza’s Joe Garrity and Jerry Jiang.

Quality Control/Quality Assurance