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Growth and Advancements in Fill/Finish
Employing novel technologies and more patient-centric approaches
Delving into Biopharmaceutical Development and Manufacturing
Quality Considerations in Changing Excipient Providers
February 02, 2023
The BioProfile FAST CDV is a fully automated viable cell density and viability analyzer.
Bio-Rad Laboratories’ EconoFit Column Packs provide resin screening for customers developing protein purification workflows.
Thermo Fisher Scientific’s QualTrak is tailored for biologics development.
The restraint to not target solely the major disease groups has provided good proportion and balance for our industry.
February 01, 2023
Any deviations from the recommendations in this guideline may be acceptable if appropriate scientific justification is provided.
FDA granted accelerated approval to Eli Lilly and Company’s pirtobrutinib for treatment of relapsed or refractory mantle cell lymphoma.
FDA approved Stemline Therapeutics’ elacestrant for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
Gerresheimer is presenting its new Clinical Trial Kit to accelerate drug development at Pharmapack in Paris.
As the development of increasingly complex biologics grows, more robust bioassays are required to accurately characterize these molecules.
Analytical techniques for validating cleaning methods must evolve to match the pace of an increasingly complex manufacturing landscape for new therapeutics.