Authors
Latest:
Recovering Patent Life with Patent Term ExtensionThe little-known exception to the patent term extension law is potentially valuable but easy to miss.
Latest:
Crowdfunding Biopharmaceutical InnovationCaution should be taken when planning to crowdfund a biopharmaceutical startup.
Latest:
Seeking Accelerated Biosimilar CharacterizationThe authors describe the qualification of an assay with applications for investigating functional comparability of an originator and biosimilar drug.
Latest:
Using the Purity Quotient Difference to Assess Protein PurificationAn automated analytical method determines the purity of chromogenic, fluorescently tagged proteins or metal-bound proteins.
Latest:
Labs on the Frontlines: Balancing Re-Entry and the Race to a COVID-19 CureHow real estate can accelerate productivity as life sciences companies prioritize COVID-19 therapeutics, vaccines, and new diagnostics R&D amidst new guidelines.
Latest:
Protecting Intellectual Property in Engagements with CMOsImportant IP contractual provisions should be included when working with CMOs.
Latest:
Mastering Cell Bank ProductionA thorough cell-bank testing plan is necessary to certify the safety and purity of a resulting biopharmaceutical product.
Latest:
Mastering Cell Bank ProductionA thorough cell-bank testing plan is necessary to certify the safety and purity of a resulting biopharmaceutical product.
Latest:
Mastering Cell Bank ProductionA thorough cell-bank testing plan is necessary to certify the safety and purity of a resulting biopharmaceutical product.
Latest:
Establishing Process Design Space for a Chromatography Purification Step: Application of Quality-by-Design PrinciplesThis case study reviews how quality-by-design principles can be implemented in an intermediate chromatography purification step that uses cation-exchange chromatography.Abstract
Latest:
Minimization of Freeze/Thaw-Induced Protein Aggregation and Optimization of a Drug Substance Formulation MatrixThe authors explore the use of statistical experimental design and multivariate analysis to develop a drug substance formulation matrix.
Latest:
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb PurificationOptimization of each phase in a chromatographic cycle has a positive impact on productivity.
Latest:
Targeted Delivery of Gene and Cell TherapiesGene and cell therapies represent the next-generation treatments for a wide range of diseases, but one challenge in the development of these therapeutics is the controlled delivery to the targeted site to maximize expression or engraftment while limiting systemic exposure.
Latest:
Minimization of Freeze/Thaw-Induced Protein Aggregation and Optimization of a Drug Substance Formulation MatrixThe authors explore the use of statistical experimental design and multivariate analysis to develop a drug substance formulation matrix.
Latest:
Practical Considerations for Demonstrating Drug Substance UniformityThe authors describe considerations and best practices for meeting drug substance uniformity.
Latest:
Stability Testing in BiopharmaThree case studies illustrate some analytical methods important for stability testing.
Latest:
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific ReproducibilityRafe Swan/Getty Images; Dan WardIrreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays a
Latest:
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific ReproducibilityRafe Swan/Getty Images; Dan WardIrreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays a
Latest:
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific ReproducibilityRafe Swan/Getty Images; Dan WardIrreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays a
Latest:
Temperature and Relative Humidity Control to Reduce Bioburden in a Closed Cell Processing and Production System without DisinfectantsControlling certain atmospheric conditions in a closed NGI processing chamber can reduce bioburden without disinfectants.
Latest:
Best Practices in Qualification of Single-Use SystemsThe author discusses the current best practices in technical qualification of single-use systems.
