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Characterizing amorphous materials with gravimetric vapour sorption techniquesEven small amounts of amorphous materials can have a significant effect on the drug product. Are gravimetric vapour sorption techniques an effective solution to characterize amorphous materials?
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Reaping the benefits of assay miniaturizationEfficiency is more than just a buzzword in today's pharmaceutical industry; declining productivity and diminishing returns on investment have made it an over-arching mindset that is critical to corporate survival.
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Criticality Management of a Drug Product and its Manufacturing ProcessCriticality management combines pharmaceutical product, process, and material knowledge and risk management in one approach, which is reflected in a single document.
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Monitoring Granulation Drying Using Near-Infrared SpectroscopyA novel probe design that reduces the variation in powder-sample density also allows moisture and solvent levels to be accurately modelled and predicted...
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LC–MS/MS method for the determination of Vitamin D3 in human plasmaAn LC–MS/MS method for the quantitative determination of vitamin D3 in human plasma has been developed and validated with positive atmospheric chemical ionization sources.
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The packaging connectionCreating better pharmaceutical and medical products with packaging partnerships.
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VC: virtuous or vampire capital?It is a universally acknowledged truth that a biotech start-up in possession of little fortune must be in want of venture capital (VC). Perhaps less well acknowledged, however, is that VC investors operate in a way consistent with being rational economic entities...
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LC–MS/MS method for the determination of Vitamin D3 in human plasmaAn LC–MS/MS method for the quantitative determination of vitamin D3 in human plasma has been developed and validated with positive atmospheric chemical ionization sources.
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Reaping the benefits of assay miniaturizationEfficiency is more than just a buzzword in today's pharmaceutical industry; declining productivity and diminishing returns on investment have made it an over-arching mindset that is critical to corporate survival.
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Predictive modelling: putting ICH guidelines to work in process validationWhen applied as part of a structured approach, predictive modelling can provide deep process and product understanding, and can enable true, continuous process validation as envisioned by ICH guidelines.
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The packaging connectionCreating better pharmaceutical and medical products with packaging partnerships.
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Developing nanoparticle formulations or poorly soluble drugsRapid advances in drug discovery have led to the identification of a number of compounds with good therapeutic potential.
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Ensuring raw material qualityThis month's expert examines the most appropriate technique for checking raw material quality. What technique would you recommend for quality checking of raw materials?
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Cycle development for hydrogen peroxide clean room decontaminationAs part of a major project to design and build a new bulk vaccine antigen plant, the authors were asked to investigate and implement a suitable fumigation system for clean room decontamination. The facility was designed to handle and contain live influenza virus, and has clean room suites designed to containment levels CL2 and CL3 according to the Approved Code Of Practice and Guidance (ACOP, Control of Substances Hazardous to Health 4th Edition). From the outset, specific areas within the facility were identified as requiring fumigation and this formed part of the initial design brief.
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Qualification of a Chromotographic ColumnIn this article, five industry experts share their insights to ensure that your column qualification protocols can survive the increased scrutiny of FDA inspectors.
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Developing nanoparticle formulations or poorly soluble drugsRapid advances in drug discovery have led to the identification of a number of compounds with good therapeutic potential.
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Managing the risks of PATOperational excellence awaits, but only if you can implement PAT successfully.
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Punch and Die Toolroom LogicHigh quality tablet compression tooling is expensive, albeit consumable. With the potential for tooling damage during tablet production, transportation and storage, an acceptable method of cleaning, repairing, validating and storing tooling is required by anyone who manufactures tablets - and the regulatory inspection authorities.
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Integration of Large-Scale Chromatography with Nanofiltration for an Ovine Polyclonal ProductThe authors examine the challenges of integrating a large-scale chromatography and nanofiltration process for purification of a polyclonal antibody.
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Regulatory Compliance Training: Who Needs It?Employees must understand the nature of the business they are in, the level of regulation that applies, and the consequences of noncompliance.
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PAT: HPLC on the horizon?PAT guidance has been available from FDA for more than 4 years, but there have been no apparent breakthroughs in large-scale upstream production. Will companies consider using on?line chromatography to change this?
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Enhancing the in vitro assessment of nasal spraysNasal drug delivery depends on many factors, including the conditions of use by the patient, the drug formulation, and the spray pump and aerosol characteristics. In recent years, the types of drug administered via the nasal route have expanded from locally acting drugs, such as those for allergic rhinitis, to delicate molecules for systemic activity, such as vaccines, proteins and peptides, which can be difficult to administer noninvasively. While the nasal cavity provides a delivery pathway for these large molecules, the rate of mucociliary clearance in the nasal cavity may hinder the extent of absorption. Therefore, formulators must develop mechanisms that improve absorption for high molecular weight compounds.
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Understanding immunogenicity responsesA discussion of the basic principles of immunity and the nature of antibodies.
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Counterfeits: reducing the growing threatSteps companies can take to help safeguard patients and the pharma supply chain.
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Erythritol: A New Multipurpose ExcipientErythritol is a bulk sweetener polyol that is suitable for a variety of reduced-calorie and sugar-free foods. It has been part of the human diet for thousands of years because of its presence in foods such as fruit, mushrooms and fermentation-derived products including wine, soy sauce and cheese. This article investigates the properties of erythritol and describes how it can be used as a pharmaceutical excipient.
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Implementing Successful Stability Testing OperationsStability studies are essential to every phase of a drug's life cycle. They not only document that a product will maintain its potency during its stated shelf life, but that it will do so under a variety of storage conditions as well.
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20th Anniversary Special Feature: Validation and qualificationHow has pharmaceutical manufacturing validation influenced analytical instrument qualification during the last 20 years and what are the emerging trends for the future?
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Pharmaceutical Reserch and Manufacturers Association Acceptable Analytical Practice for Analytical Method TransferThis article presents the findings of PhRMA's annual workshop, held in September 2000, that convened to draft an acceptable analytical practice that would clarify the essential elements of a complete and compliant transfer.
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Spherical Crystallization for Lean Solid-Dosage Manufacturing (Part II)In Part I of this article, which appeard in the March 2010 issue, the authors describe their approach for constructing form spaces for carbamazepine, cimetidine, and phenylbutazone by initial solvent screening to evaluate the feasibility of spherical crystallization. Part II of this article discusses their findings.
