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Expedite Regulated Documents in the Era of COVID-19: From Development to Trials and ManufacturingTechnology is more critical than ever to help you keep your clinical trials on track during the era of COVID-19. Gain best practices about how to empower your remote workforce, get critical regulated documents electronically signed compliantly, and to create a safe and flexible remote patient-centric experience. Live: Wednesday, Jul. 15, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Jul. 15, 2021. Register free
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Quality Metrics and CMO AgreementFDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.
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Determining Minimum Batch SizeFlexible batch sizes for semi-continuous unit operations, such as tableting and encapsulation, can improve efficiency while maintaining quality.
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Novel Formulations and Line Extensions with Soft Capsule TechnologyAdvancements in soft capsule technology can enable the development of soft capsule formulations, which are becoming the preferred method of oral administration.
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Evaluating Technology and Innovation in Biopharmaceutical ManufacturingA technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.
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Evaluating Technology and Innovation in Biopharmaceutical ManufacturingA technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.
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Evaluating Technology and Innovation in Biopharmaceutical ManufacturingA technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.
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Evaluating Technology and Innovation in Biopharmaceutical ManufacturingA technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.
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Evaluating Technology and Innovation in Biopharmaceutical ManufacturingA technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.
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Evaluating Technology and Innovation in Biopharmaceutical ManufacturingA technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.
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Effective Technology Transfer and Validation Strategies with CMOsThe success of a pharmaceutical manufacturing transfer from one facility to another requires detailed operational plans, attention to detail, and coordination between all parties. \
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Purification of Peptides Using Surrogate Stationary Phases on Reversed-Phase ColumnsThis paper describes a unique Prep-rP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).
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Purification of Peptides Using Surrogate Stationary Phases on Reversed-Phase ColumnsThis paper describes a unique Prep-rP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).
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Purification of Peptides Using Surrogate Stationary Phases on Reversed-Phase ColumnsThis paper describes a unique Prep-rP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).
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Purification of Peptides Using Surrogate Stationary Phases on Reversed-Phase ColumnsThis paper describes a unique Prep-rP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).
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Cleaning Limits—Why the 10-ppm and 0.001-Dose Criteria Should be Abandoned, Part IIConventional limit-setting techniques are not health-based and can make risk assessment more difficult.
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Debating the Role of RABS and Isolators in Aseptic ManufacturingWhile isolators may offer advantages in high-speed commercial manufacturing lines, RABS continues to be a flexible alternative solution for small-scale production of drugs for clinical use.
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Planning for Successful Technology TransferThe author reviews some of the key considerations when selecting a vendor and crucial parameters that must be defined in the tech-transfer process to ensure the greatest chance of success.
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In-Process Particle CharacterisationIn wet granulation, many companies used to rely on empirical data and quality control, but processes and technologies have improved in a variety of ways in recent years.
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Using Process Capability for Statistical Evaluation of Cleaning ProcessesThis study examines the use of process capability index results to establish sampling strategies for new product cleaning and to minimize the risk of insufficient cleaning.
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Commonly Cited Deficiencies for Topical Dermatologic Drug Products in ANDAsThe authors of "Common Deficiencies in ANDAs for Dermatologic Drug Products" provide some examples of commonly cited deficiencies cited by FDA.
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Commonly Cited Deficiencies for Topical Dermatologic Drug Products in ANDAsThe authors of "Common Deficiencies in ANDAs for Dermatologic Drug Products" provide some examples of commonly cited deficiencies cited by FDA.
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Ophthalmic Drug Packaging: Safety Risks and Patient Acceptability IssuesThe authors describe some cases of container closure design flaws and actions taken by FDA to mitigate safety risks and increase patient acceptability.
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Common Deficiencies in ANDAs for Dermatologic Drug ProductsCompanies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.
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Ophthalmic Drug Packaging: Safety Risks and Patient Acceptability IssuesThe authors describe some cases of container closure design flaws and actions taken by FDA to mitigate safety risks and increase patient acceptability.
