Authors
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Outsourcing Stability StudiesThe author provides advice about evaluating contract analytical laboratories and establishing an effective procedure for working with them to perform reliable stability studies.
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20th Anniversary Special Feature: The impact of regulationsDuring the past two decades, regulations have evolved in both Europe and the US to accommodate the technological developments in the pharmaceutical, biotechnology and medical device industries.
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Sustainability in green pharmaceutical productionReducing ecological footprint and achieving more sustainable production of pharmaceuticals could help create a better future.
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20th Anniversary Special Feature: The impact of regulationsDuring the past two decades, regulations have evolved in both Europe and the US to accommodate the technological developments in the pharmaceutical, biotechnology and medical device industries.
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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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Tablet discolourationWe are currently experiencing a problem with one of our tablet lines. While the tablets appear white immediately after manufacture, after a time many of the tablets begin to take on a yellowish appearance. Could this be an issue that surface analysis could help resolve?
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RFID versus BarcodeData capture needs to be fast and reliable...so which automatic identification technology is best?
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Pseudo-polymorphic conversion by near-infrared spectroscopyNear-infrared spectroscopy (NIR) is suitable for the analysis of pharmaceutical samples in various solid forms, and can be used for determining chemical properties (e.g., content of drug, water), as well as physical properties (e.g., particle size, tablet hardness).
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How will Pfizer fight failure?Pfizer is no normal company. As recently as 2007 it was still the industry's largest player with $47.5 billion (36.8 billion euro) coming in from pharma sales alone.
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Application-related properties of a new fast dispersible excipientA new excipient for orally disintegrating tablets not only imparts superior tablet characteristics, but has the added advantage of allowing users to maintain full control over their formulations, manufacturing processes and intellectual property.
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Effective complaint handling, investigations and adverse event reportingThe challenges of ineffective quality monitoring of complaints, investigations and adverse event reporting can lead to patient harm or death, product withdrawal, and negative financial and brand impact to the organization.
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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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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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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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The packaging connectionCreating better pharmaceutical and medical products with packaging partnerships.
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Western promisesAccess to the capital markets of the US has always been a key attraction for Europe's biotech businesses.
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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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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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Using a Delphi Survey to Assess the Value of Pharmaceutical Process Validation Part 1: Survey MethodologyDuring autumn 2001, a Delphi survey was conducted using the Internet to discover the opinions of European experts from the pharmaceutical fields of industry, regulation and academia regarding pharmaceutical process validation. The Internet Delphi method was found to be an appropriate tool for exploring the opinions and experiences of pharmaceutical manufacturing because it allowed anonymous participation and discussion between geographically dispersed parties. However, to obtain reliable results, many factors were taken into account, as this article examines.
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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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Zebrafish: a multifaceted approach for drug safety assessmentMany compounds fail in preclinical development because of safety-related problems, but identifying 'predictable' safety or toxicity liabilities earlier in the process could lead to improved design and selection of compounds that are more likely to be approved.
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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.
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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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Learning from Lean SigmaLean Sigma approaches can reduce waste, cost, cycle time and variability in outputs.
