Authors
Latest:
Growth Kinetics of Human Mesenchymal Stem Cells in a 3-L Single-Use, Stirred-Tank BioreactorThe authors describe the growth characteristics of human mesenchymal stem cells cultured in a stirred-tank bioreactor.
Latest:
Identification and Quantification of Trace-Level Protein ImpuritiesA simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics is described.
Latest:
Optimizing Human Performance: A Road Worth Traveling, Part 3This article is the third and final in a series designed to offer leaders and managers at all levels in the industry a road map to excellence in human performance and human error prevention.
Latest:
Patents and Postapproval Batch TestingCan postapproval FDA filings immunize pharma companies from patent lawsuits?
Latest:
Managing Contract Manufacturing Organization RelationshipsSuccessful management of the CMO/client relationship should include open communication and trust.
Latest:
Biologics: Can There Be Abbreviated Applications, Generics, or Follow-On Products?In this question-and-answer discussion of "generic" biologics, the authors contend small changes in manufacturing of biologics dramatically affect the safety and efficacy of the therapeutic molecule.
Latest:
When the Process Becomes the Product: Single-Use Technology and the Next Biomanufacturing ParadigmThe move to single-use manufacturing has prompted a paradigm shift in facility design.
Latest:
Identification and Quantification of Trace-Level Protein ImpuritiesA simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics is described.
Latest:
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and BetterTraditional project decision-making vs. a QbD approach.
Latest:
Polishing Complex Therapeutic ProteinsA new downstream purification platform using a salt-tolerant membrane adsorber.
Latest:
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media TechnologyAdvances in cell culture media technology have helped achieve safer biologics.
Latest:
Cellular and Gene Therapies Face a Manufacturing Capacity CrunchCellular and gene therapy fields are currently on track for, if not already experiencing, a serious capacity crunch.
Latest:
Single-Use Redundant FiltrationThe authors describe a new assembly for bulk and final drug product filling operations.
Latest:
Costing Issues in the Production of BiopharmaceuticalsOperational planning and early cost analyses are key to generating optimal, robust, and economical commercial processes.
Latest:
Ice Fog as a Means to Induce Uniform Ice Nucleation During Lyophilization (Peer Reviewed)The authors describe a novel means to control ice nucleation using a sterile cryogenic ice fog.
Latest:
A Method for Removal of Endotoxin from Pharmaceutical FormulationThe authors describe a simple method to remove endotoxins from highly viscous formulations.
Latest:
Single-Use Technology for Syringe FillingA novel approach to sterile drug product manufacturing uses a single-use assembly in a multi-product final filling suite with isolator technology.
Latest:
Unveiling CQA Insights for mRNA, LNPs, and Viral Vectors by SEC and MALS With Novel 1000 Å Ultrawide Pore Particle ColumnsWebinar Date/Time: Thu, Sep 5, 2024 11:00 AM EDT
Latest:
The Case for Pediatric ExclusivityReauthorization of pediatric exclusivity provisions looms in 2012 and debates begin anew.
Latest:
A Protocol for Trademark ProtectionThe Madrid Protocol offers companies another option for trademark registration on a global scale.
Latest:
Mechanistic Modeling of Preparative Ion-Exchange ChromatographyChromatography modeling can enhance bioprocessing efficiencies.
Latest:
Strategic Outsourcing in Clinical DevelopmentPartnering with CDMOs can help bridge the innovation gap.
Latest:
HIV Drugs Produced from Goats Show PromiseMolecular mimicry is a common, but undesirable, property of disease proteins. Sequence similarities between cancer proteins and self-proteins allow tumor cells to hide, thereby avoiding attack from the immune system. HIV uses the same evasive tactic.
