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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
July 16, 2021
The ever-increasing complexity of biotherapeutic molecules presents unique analytical challenges for developers.
Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.
July 01, 2021
New biologic modalities, such as cell and gene therapies, pose increasing difficulties in viral clearance testing methods.
Help prevent contamination in a facility by zone.
Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel.
June 01, 2021
Digitalization of bioprocessing operations, equipment, and facilities can improve workflow and output, but maintaining data integrity is a concern.
The increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.
May 26, 2021
ISPE’s latest guide ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry focuses on how knowledge management allows for a more effective pharmaceutical quality system.
May 16, 2021
Assessing biosafety using NGS-based tests requires a continuum of skills in molecular biology, biocomputing, virology, and quality systems.
The COVID-19 pandemic has triggered additional considerations to supplier oversight of contract manufacturing facilities.