By Alfredo Canhoto, Associate Director Technical Solutions Practice, ProPharma Group
Quick, can you name the top 10 critical process parameters (CPPs) and critical quality attributes (CQAs) of your biopharmaceutical manufacturing process? Well, if you hesitated, don't feel bad. Most pharmaceutical process validation and engineering professionals could probably only list three or four of each for products that they should be intimately familiar with.
By Archana Gangakhedkar, Technical Marketing Specialist, American Peptide Company, Inc.
Bicyclic peptides are an emerging class of peptide molecules used to explore new cellular sites which are undruggable by small molecules or by large antibodies. Bicyclic peptides have some favorable properties when compared to current drug classes, and will likely open a new path for targeting diseases.
By Richard Mirro, Eppendorf Inc.
This application report presents a simple protocol for achieving high-density culture of Sf-9 insect cells using a New Brunswick benchtop, autoclavable, stirred-tank bioreactor.
By A. Lennaertz, S. Knowles, J.C. Drugmand, and J. Castillo
Wild-type or recombinant viruses used as vaccines and human gene therapy vectors are an important development tool in modern medicine. Some have demonstrated high potential, such as lentivirus, paramyxovirus, and adeno-associated-virus (AAV).
By Ryan Mauro, Validations Sales Specialist, Sartorius Stedim Biotech
Process validation is the collection and evaluation of data throughout the manufacturing process, which establishes, scientifically, that there is consistency of quality, reproducibility, and traceability from batch to batch.