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Moisture Matters in Lyophilized Drug ProductUsing an alternate moisture-generation method may provide more accurate data for regulatory submissions.
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The Power of In Vitro Assays in Immuno-OncologyThe combination of translatable in-vitro and in-vivo assays, coupled with expertise in immunology and oncology helps facilitate the progression of novel oncology therapeutics from hit identification to investigational new drug submission.
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A Look Ahead at Manufacturing and RegulationFDA talks about the changing scope of regulatory science and its effect on drug reviews, site inspections, and overall approaches.
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Healthcare Reform and Next Battles for IndustryThis guest blog was written by Christie Bloomquist is a partner in health practice at Hogan Lovells, a global legal practice firm based in Washington DC.
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Creating a Holistic Procurement SystemThe procurement organization rethinks sourcing for maximum efficiency and results.
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Outsourcing stem cell storageWhy is the correct storage of stem cells so important for the future of medical innovation?
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Opportunities and Challenges in the Development of Stem-Cell TherapiesStem cells are being developed to treat a diverse set of conditions, including spinal cord injury, amyotrophic lateral sclerosis, macular degeneration, Parkinsons disease, and Type I diabetes. But the challenges in moving from the laboratory to the clinic are formidable.
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Advancing Pharma’s Social Media Listening AnalyticsThe pharmaceutical industry still lags other industries in spending on outbound social media programs that engage customers directly.
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EMA Seeks to Expand Collaboration on Orphan MedicinesThe European Medicines Agency?s Committee for Orphan Medicinal Products (COMP) is seeking to expand its international cooperation in 2013.
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Fit for the Lung?Advances in engineered particles and the subsequent reduction in the API mass required to achieve a therapeutic dose can lead to a reduction in side effects.
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Fit for the Lung?Advances in engineered particles and the subsequent reduction in the API mass required to achieve a therapeutic dose can lead to a reduction in side effects.
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The Squeeze in Contract ManufacturingThe demand for CGMP production of biopharmaceuticals is at an all-time high.
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Successfully Outsourcing Formulation DevelopmentConsiderations for Emerging Biopharmaceutical CompaniesSuccessfully taking a new chemical entity from proof-of-concept to commercialization requires the biopharmaceutical company to carefully evaluate a contract services provider's formulation department and ability to become a fully integrated supplier.
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Effects of Natural and Pregelantinized Sorghum, Plantain, and Corn Starch Binders on the Compressional Characteristics of a Paracetamol Tablet FormulationThis comparative study suggests that pregelatinized starches are superior to natural starches in terms of improving the plastic deformation in tablet formulations during compression.
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Formulation of Acetylsalicylic Acid Tablets for Aqueous Enteric Film CoatingThis study attempts to determine the combination of excipients found in commercial ASA products that would be suitable for use in an aqueous enteric film­coating process.
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Formulation of Acetylsalicylic Acid Tablets for Aqueous Enteric Film CoatingThis study attempts to determine the combination of excipients found in commercial ASA products that would be suitable for use in an aqueous enteric film­coating process.
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Compendium of Pharmaceutical Excipients for Vaginal FormulationsTo aid the fomulation scientist in selecting the optimal excipients for the preparation of vaginal products, the authors have compiled a list of all presently available vaginal excipients, including their functional categories and regulatory status.
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Diversifying the Global Heparin Supply Chain: Reintroduction of Bovine Heparin in the United States?The global supply chain for bovine and porcine heparin and regulatory considerations are examined.
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Determination of Related Substances in Pemetrexed Disodium (Form-IV) in Bulk Drug Samples by HPLCThe authors describe the development of a stability-indicating reverse-phase high-performance liquid chromatographic (RP?HPLC) method for the quantitative determination of potential genotoxic impurities present in pemetrexed disodium (form-IV). The chromatographic separation was achieved on a RP?HPLC column (Zorbax SB-Phenyl, Agilent) at ambient temperature with gradient elution using mobile phase A (trifluoroacetic acid [TFA] in water) and mobile phase B (TFA in acetonitrile).
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Film Coating with Aqueous Latex DispersionsThe authors provide an overview of formulating latex dispersions with pigments for the film coating of solid dosage forms, including factors such as regulation, methods for assessing stability, and surface chemistry.
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Film Coating with Aqueous Latex DispersionsThe authors provide an overview of formulating latex dispersions with pigments for the film coating of solid dosage forms, including factors such as regulation, methods for assessing stability, and surface chemistry.
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Compendium of Pharmaceutical Excipients for Vaginal FormulationsTo aid the fomulation scientist in selecting the optimal excipients for the preparation of vaginal products, the authors have compiled a list of all presently available vaginal excipients, including their functional categories and regulatory status.
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Compendium of Pharmaceutical Excipients for Vaginal FormulationsTo aid the fomulation scientist in selecting the optimal excipients for the preparation of vaginal products, the authors have compiled a list of all presently available vaginal excipients, including their functional categories and regulatory status.
Latest:
Compendium of Pharmaceutical Excipients for Vaginal FormulationsTo aid the fomulation scientist in selecting the optimal excipients for the preparation of vaginal products, the authors have compiled a list of all presently available vaginal excipients, including their functional categories and regulatory status.
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Passion, Innovation, and LossAt a time when the industry is struggling with innovation, it might do well to learn a lesson from a few great innovators.
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Next-Generation Therapeutics on the HorizonDevelopments in RNAi, monoclonal antibodies, and more are boosting the biotech marketplace.
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Filtration Clarification Needs in Annex 1Misalignment around liquid filtration requirements and contamination control assurance still persist despite the revisions to Annex 1.
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The Next Generation of Aseptic Processing EquipmentThe industry has acknowledged only recently the significance of the contamination risk posed by humans. The authors assert that this realization, together with technological advances, will lead to the elimination of human intervention and, hence, improved sterility.
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Moving Out of the Lab to Optimize Microbial ControlMicrobial experts should employ proactive practices on the manufacturing floor, rather than relying on testing.
