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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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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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Development of PVA Copolymer CapsulesThe bioavailability of some insoluble drugs is enhanced when they are dissolved in the solubilizing agent macrogol 400, although conventional hard capsules cannot tolerate the agent. This article investigates a PVA copolymer, which has been developed by the authors, examining its properties and its suitability as a material in capsule formulations.
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Effects of Polyethylene Glycol on Morphology, Thermomechanical Properties, and Water Vapor Permeability of Cellulose Acetate-Free FilmsThe authors provide a systematic evaluation of the effects of solvent systems, PEG molecular weight, and concentration of CA to PEG on the thermomechanical properties and permeabilities of CA-free films.
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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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Bioanalysis of recombinant proteins by mass spectrometryBiotechnological developments have led to an increased number of recombinant proteins or antibodies in drug development that offer high potential in various diseases, such as cancer, growth disturbances and diabetes.
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Fast dissolving disintegrating tablets with isomaltDuring the past years, there has been increasing demand for fast dissolving disintegrating tablets (FDDTs), such as orally disintegrating tablets (ODTs) and sublinguals.
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Rapid and convenient microsphere sizingFDA advocates building quality into a product through PAT.
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Upcoming technologies to facilitate more efficient biologics manufacturingThe number of biotechnology-based human therapeutic products in the late-stage pipeline along with the average cost to commercialize a biotech product has been steadily increasing with time. In addition, the biotech industry is facing unprecedented challenges of a sagging global economy and rising regulatory expectations. Companies have to continue to evolve their approaches to be more efficient with respect to time, resources and cost. This article describes some of the technologies that can help optimize time and cost of biopharmaecutical manufacturing.
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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...
Latest:
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...
Latest:
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.
Latest:
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.
Latest:
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?
