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Uniformity of Bioprocessing Equipment ManufacturingThe American Society of Mechanical Engineers' Council on Codes and Standards established an ad hoc committee to examine whether a standard to create uniformity and consistency in the bioprocessing industry is needed. This article describes the goals and current activities of the standards committee and its subcommittees.
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Elasticity – A Modern Paradigm for a High Performance WorkforceTop C-suite leaders are already tuning their long-range planning, hiring practices, and business systems for elasticity. Are you ready?
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Considerations for Cleaning Lipid NanoparticlesThis article explores the concerns with cleaning pharmaceutical products utilizing LNP delivery vehicles and provides a general cleaning recommendation based on laboratory and field testing.
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Point-of-Use Leak Testing of Single-Use Bag AssembliesThe authors describe the development and validation of a highly sensitive point-of-use pressure decay test.
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Ask the Expert: Quality Control UnitsIn this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how to address an FDA warning letter citation for a failure to establish a quality control unit.
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Shining a Light on Lipid Nanoparticle CharacterizationUsing an orthogonal approach to lipid nanoparticle analysis can increase the odds of project success.
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The Transition to Electronic RecordsA four-stage process to successfully make the switch from paper to electronic batch records is presented.
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Characterization and Impurity Analysis of Oligonucleotide TherapeuticsAnalytical technologies play a key role in the characterization and quantitation of oligonucleotide therapeutics.
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Understanding Internal Release LimitsInternal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.
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A Statistical Decision System for Out-of-Trend EvaluationThe authors present a set of statistical decision rules based on linear regression models that can be implemented in an automated trend system to assist stability studies.
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SCHOTT Vials DC Demonstrate Resistance against Delamination in New Screening StudyA new series of studies has demonstrated the effectiveness of SCHOTT Vials Delamination Controlled (DC), which can replace existing packaging solutions without re-registration and offers higher product security.
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Ensuring the Biological Integrity of Raw MaterialsA multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.
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The GMP/GDP Inspections Landscape—Part II: Considerations and OpportunitiesThe authors look at challenges and considerations to continuously improve inspection efficiency.
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The GMP/GDP Inspections Landscape—Part II: Considerations and OpportunitiesThe authors look at challenges and considerations to continuously improve inspection efficiency.
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The GMP/GDP Inspections Landscape—Part II: Considerations and OpportunitiesThe authors look at challenges and considerations to continuously improve inspection efficiency.
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The GMP/GDP Inspections Landscape—Part II: Considerations and OpportunitiesThe authors look at challenges and considerations to continuously improve inspection efficiency.
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Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAsThe authors survey deficiency letters issued for 190 drug master files supporting abbreviated new drug application submissions.
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Appendix: Common Deficiencies Related to Solution NMR in the Type-II DMFsAppendix to Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAs, Part I: Solution Nuclear Magnetic Resonance Spectroscopy
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Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAsThe authors survey deficiency letters issued for 190 drug master files supporting abbreviated new drug application submissions.
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Appendix: Common Deficiencies Related to Solution NMR in the Type-II DMFsAppendix to Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAs, Part I: Solution Nuclear Magnetic Resonance Spectroscopy
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Continuous Manufacturing: A Generic Industry PerspectiveThe pharmaceutical industry is making efforts by internally assessing, developing, and implementing semi-continuous manufacturing processes to improve manufacturing efficiencies.
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Careful, Early Cold-Chain Planning is Crucial for New BiologicsCold-chain requirements and the tight logistical windows needed for cell and gene therapies demand a focus on early communication and risk mitigation.
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Serialization: The Final CountdownMany pharmaceutical manufacturers were late in involving contract partners in serialization efforts. Are you ready, and are you working with the right partner?
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Serialization Preparation Prompts Data and Business QuestionsAs the date for implementation of the Drug Supply Chain Security Act approaches, bio/pharma companies and contractors should focus on key areas.
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Monitoring Supply Chain Risk on a Limited BudgetMonitoring supply-chain risk involves more than running a credit check on potential suppliers. It can, however, done without external expense.
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Evaluating E&L Studies for Single-Use SystemsExtraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
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Evaluating E&L Studies for Single-Use SystemsExtraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
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Evaluating E&L Studies for Single-Use SystemsExtraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
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Evaluating E&L Studies for Single-Use SystemsExtraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
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Collaborating for Efficiency and Safety in Raw Material InspectionBy working together and taking a QA-based approach, manufacturers and suppliers can reduce raw material testing requirements.
