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Overcoming Low Endotoxin RecoveryUnderstanding of endotoxin assays and a range of detection technologies are essential for effective testing.
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Enhancing API Solubility During API Processing and Formulation Development MerckUnderstanding the impact of API solubility on the performance of a given drug product and determining ways to enhance dissolution rates is critical to ensuring your product makes it to market, into the hands of patients and clinicians, is well absorbed and provides its intended therapeutic effect. Selecting the best formulation strategy to address challenges for each API, however, can be time-consuming, costly and complex.
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GE Healthcare: The Next Cell and Gene Therapy Manufacturing Giant?GE Healthcare continues to ramp up its offerings in the bioprocessing space with the purchase of Asymptote and a continued partnership with Zenith Technologies.
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Boosting Bioproduction Workflows with Automation TechnologiesAs cost pressures mount as a result of multiple biologics being developed for the same indication, manufacturers can harness process efficiencies to maintain the value of legacy products.
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What Ifs in the Five-Year PlanHeightened uncertainty means CDMO executives need to play out planning scenarios.
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Adapting Regulations Post-BrexitThe UK government is taking advantage of the new regulatory flexibility, afforded by Brexit, to boost the country’s competitiveness in pharma.
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Business on Hold? EMA’s Full Recovery in QuestionEMA is facing a dilemma in trying to restore activities back to normal after relocating and the COVID-19 pandemic.
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Signing Off from WashingtonFDA and industry face unprecedented political and policy challenges.
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FDA Highlights Value and Challenges of Advanced Drug ManufacturingFDA is expanding its Emerging Technology Program and providing more support for new drug applications that present advanced manufacturing technologies.
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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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Developments in Aseptic ProcessingCompliance and competitiveness are key factors in aseptic processing, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.
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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.
Latest:
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
