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Preclinical Testing for the Medical Device Industry – Material Properties, Leachables/Extractables, and Surface Cleanliness
Jonas Weissenrieder, Ph.D. Pace Analytical Life Sciences Oakdale, Minnesota
Effects of Material and Chemical properties on the biological profile
Chemical and Material Analysis
Why do chemical characterization? Equivalence studies? Economy?
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The requirements for sterile technique depend on the experimental situation including the growth media used, the experimental organism, the duration of the experiment and the intended use of the culture. For these experiments the most serious contaminant is mold. Many common molds grow well on yeast media and compete effectively to over-grow the plates and obscuring the yeasts that do manage to grow. Bacteria are less problematic since most do not grow well on these media. It is advised ...
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Ribavirin is an antiviral prodrug used for the treatment of Hepatitis C and respiratory syncytial virus (RSV) among other common viruses. A method for the analysis and quantification of ribavirin in rat plasma utilizing HPLC-MS/MS with updated HPLC column technology has been developed and validated according to the FDA guidance to the industry.
The assay displays good linearity with correlation coefficient >0.99 over a range of 10 – 5000 ng/mL using a 25 µL sample precipitated with 5mM ...
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The performance of the Joyce-Loebl disk centrifuge in the sizing of Escherichia coli cells,protein inclusion bodies, and cell debris is evaluated. Theneed for a density gradient that extends throughout the entire spin fluid is highlighted, and a set of standard conditions that fulfill this requirement is defined. E. coli cells experience a reduction in their Stokes diameter when exposed to ethanol, indicating that a spin-buffer fluid combination such as glycerol-water is to be preferred for the ...
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It is well-known that certain cancer cells have a hormone dependence and that earlier diagnosis and treatment of hormonally driven cancers can be based on the chemical profile of a tumor. Estrogens and their metabolites are suspected in the development and growth of certain types of breast cancer. Current analytical methodology limits screening of samples due to the extended analytical times required for adequate chromatographic separation of these metabolites. With requirements for analysis of ...
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The science, art, and practice of protein purification have been with us for more than a century, yet, in many respects,
the field is only now evolving past its adolescent roots. New methods are replacing old methods at such a dizzying
pace, that even life-long experts in protein purification cannot keep up. In this article, we present many state-of-the-art
protein purification techniques without totally ignoring the past. Our goal is to enable those relatively new to the field of
protein ...
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Background: The University of Virginia School of Medicine dis- continued animal vivisection in February 2004 for teaching lifesav- ing procedures to third-year medical students. Consequently, a 1-day course using simulation technology was developed to meet objec- tives previously covered in the animal laboratory. The authors sought to evaluate the course and hypothesized that the students' condence in lifesaving procedures as well as their acceptance of simulation technology as a teaching tool ...
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Shimadzu protein instruments open new avenues to speed biomarkers to the clinic
Discovery Verification Validation Application
Is a patient really sick? What medicine is necessary? In what dosage? Is the patient responding to it? Doctors customarily answer these questions based on a variety of symptoms. But many of the symptoms used today, because of their subjective description and uncertain relationship to the disease state, are misleading.
Scientists are rushing to find new `biomarkers' — ...
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Size exclusion chromatography (SEC) is a chromatographic method in which particles are separated based on their hydrodynamic vol- ume. When the separation medium is a gel, the technique is known as gel permeation chroma- tography (GPC) or gel filtration chromatogra- phy (GFC). Often the terms SEC and GPC are used interchangeably, while GFC is most often used for aqueous chromatography. Conventional SEC The minimal instrumentation needed for SEC consists of the following: HPLC pump, injec- tor, ...
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Concern regarding extractables and leachables has been increasing over the past few years, as evidenced by regulatory guidance documents [1-3]. One means of qualifying a component as being suitable for use in a drug product is to determine the extraction profile of that component in multiple solvents with polarities similar to and bracketing that of the product vehicle. Any observed extractables can then be identified and potential leachable concentrations assessed by a toxicologist to ...
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UHPLC often provides run times of less than one minute with peak widths of less than 200 milliseconds, which have created challenges for system performance and detection methods. A variety of applications in the pharmaceutical and environmental areas, using small particle columns, is presented to demonstrate the throughput and performance of the new Nexera UHPLC.
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The transition from LC to ultrafast LC reduces some of the limitations normally associated with LC. However, when LC analysis is conducted using an ordinary detector like an absorbance detector, only retention time information can be considered reliable. Using a Mass Spectrometer as an LC detector alleviates this issue, and this paper demonstrates how ultrafast LC/MS significantly enhances LC analysis.
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Demonstrating the chromatographic performance and LCMS analysis for components of customer-provided samples utilizing the single-quad LCMS-2020, with the objective of attaining resolution of 5 components from a test mix in a total method runtime of 2 minutes or less, including MS spectral peaks.
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Challenge your company to find creative ways to lower your costs with your goals. By optimizing the management of non-core activities you can save money, increase performance and improve workforce productivity.
In the competitive, highly regulated business climate that exists in the life science industry, companies are challenged to find creative ways to lower their costs without compromising the goal of producing high quality products, while maintaining regulatory and compliance standards ...
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Upgraded MagSi products can seamlessly replace discontinued Dynabeads®
MagnaMedics Diagnostics B.V. have developed a high magnetic content (HMC) bead with sizes of 0.6 µm and 1.0 µm (1.2 µm for MagSi- proteomics and MagSi-DNA allround beads) to replace all previous MagSi products. The use of a novel, newly developed ferro fluid (Mag-Ferro) with an magnetisation of up to 40 emu/g raises the magnetic content from ~30% to 50% enhancing the time to magnet significantly (Figure 1).
Figure 1: The ...
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Knowledge is power. When it comes to choosing your suppliers for buying instruments, equipment or services, are you effectively utilizing maintenance and service information to help you make wise purchasing decisions? Do you know how well your suppliers are performing? Do you know how your manufacturers and service providers compare to each other in quality and service delivery? Do you have the tools and information to help you leverage the volume of your purchasing power and negotiate better ...
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By Bruce B. Weiner Ph.D Brookhaven Instruments Corporation 750 Blue Point Road Holtsville, NY 11742-1832 USA
Introduction: The choice of a particle size analyzer has never been more difficult. There are several techniques from which to choose and variations within each technique. Sales literature claims of specification and performance have become highly inflated, confusing the first-time buyer; the result has been to hinder and not help the decision making process. Many particle sizing ...
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2-Acetoxy-benzoic acid (also known by the common name aspirin) has several applications in fields ranging from pharmaceutical synthesis1 to biology2 and pharmacology.3 Several 2-acetoxybenzoic acid derivatives, which incorpo- rate stable isotopes (i.e. 2H and 13C) have been synthesized,4 however, relatively few radiosyntheses of 2-acetoxybenzoic acid derivatives have been reported.5 Furthermore, the few reported syntheses of radiolabeled 2-acetoxy benzoic acid derivatives typically had low ...
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Commercially available sub-2µm or sub-3µm particle columns have been used to shorten analytical time in a wide range of fields. Columns with such smaller particles improve separation efficiency and allow use of shorter columns and higher linear velocity without compromising the separation. In particular, sub-3µm columns such as 2.2µm particle columns provide similar separation efficiency to sub-2µm columns with much lower pressure so that the column can be accommodated by conventional HPLC ...
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The ability to respond to ever-evolving consumer at- titudes, regulatory mandates, and scientic discov- eries requires that manufacturers keep their nger on the pulse of the analytical methodologies required to monitor product safety and quality. In light of the ever- growing number of food and supplement ingredients and complex formulations, the ability to detect unique com- pounds and quantify levels of ingredients at trace levels presents challenges to researchers. The increased efciency and ...
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Preparation of Elastic Plastics for the Detection of PAH
Polycyclic aromatic hydrocarbons, short PAH, are usually a by- product of combustion and can be found, for example, in cigarette smoke or oil-based products. Mineral oil containing PAH is often used in rubber products as plasticizer, especially in black-coloured products such as car tyres, rubber grips of tools or rubber shoe soles. It was discovered that some polycyclic aromatic hydrocarbons are carcinogenic, so that maximum permissible ...
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Benzphetamine hydrochloride is a sympathomimetic amine with pharmacologic activity similar to the amphetamine class of compounds. Presented is data from the bioanalytical validation of a high performance liquid chromatography, tandem mass spectrometry (HPLC-MS/MS) method for the analysis of benzphetamine in human heparanized plasma. Sample preparation was accomplished using a liquid-liquid extraction with chromatographic separation using a C-8 column. The relationship between benzphetamine ...
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Qualitative and Quantitative Aspects of Peptide Mapping Using UPLC-UV
Peptide mapping or peptide finger printing produced is characteristic for a particular protein and the UPLC technique can be used to separate a mixture of peptides.
Normally, recombinant proteins are developed for therapeutic purposes. Peptide mapping is used to confirm the primary structure of a protein, identify post-translational modification, to demonstrate generic stability and analyze potential impurities. Any ...
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In vitro:in vivo Correlation: Topical Delivery Review of the literature of the past 40+ years reveals the great extent to which our understanding of the fun- damentals of percutaneous absorption depends upon a simple, yet multifaceted, model system: the in vitro use of excised animal or human skin mounted as a barrier be- tween two glass chambers. For those who believe that data obtained in vitro using human skin is an adequate representation of living man, the model has become a means to ...
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Phase analysis light scattering (PALS) is a new technique that has been developed to measure the electrophoretic mobility of charged particles and offers high sensitivity at the low mobilities typical of many food colloids. The first application of PALS to the characterisation of food colloids is discussed below. The superiority of the method to conventional laser Doppler electrophoresis (LDE) techniques is demonstrated in certain food systems.
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Abstract: This paper will discuss the use of pattern recognition techniques to identify and differentiate different particle types contained in a heterogeneous solution. This application involves imaging microscopic particles in real- time as they flow in a solution, segregating each individual particle as a separate image, and then applying pattern recognition techniques to differentiate the individual particle types. A framework for discussing the complexity of a pattern recognition operation ...
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Measurement Techniques for Incremental Sensors
by Dr.-Ing. Franz Hillenbrand and Dipl.-Ing. Kamil Pogorzelski
Measurement of angle, distance, frequency, and speed, as well as general event counting measurements are commonplace in a variety of industrial situations including gearboxes, engine and motor operation, conveyor belts, milling and drilling machinery, and robotic assembly systems. This paper explains the mea- surement techniques for, resolution consideration of, and the ...
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the stability of a lyophilized igG1 monoclonal antibody was investigated using suboptimal levels of the lyoprotectant, sucrose and the incorporation of the plasticizer, sorbitol. after lyophilization, aggregation and sub-visible particle formation in the reconstituted formulations were evaluated by a number of techniques chosen to encompass a wide range of aggregate sizes. these methods included micro-flow imaging (mfi) to quantify and characterize subvisible particles, dynamic light scattering ...
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Abstract: Imaging particle analysis represents an exciting method of particle analysis which combines the speed of automated particle analyzers with the discrimination found in optical microscopy. However, in order to discriminate shape differences, it is limited to particles of a certain size or larger (see Figure 1) . This paper discusses the primary factors that lead to this limitation, caused by the optical system and the sensor. In the end, diffraction limits of the optical system and ...
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A Filamatic White Paper on the basics of liquid filling including filling techniques, metering systems, and nozzles
When beginning your liquid filling equipment search, it is important to consider the different aspects of your product (or application) and the demands of your project. There are four characteristics that will help in determining the type of filling machine you will need: the liquid’s nature or characteristics, fill volume(s), production rate(s), and container ...
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Human plasma samples spiked with apomorphine and internal standard were extracted using a liquid/liquid extraction technique. Quantitation was performed on a PE Sciex API 3000 LC-MS/MS system with Turbo Ion Spray operating in positive ion Multiple Reaction Monitoring (MRM) mode. Standard curves were produced by linear regression using the peak area ratios of analyte to internal standard and a 1/x weighting.
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Occupational exposure and alleged health effects situations are complex and contain several components which may include physical, psychological and emotional effects on workers potentially exposed or effected. A thorough investigation is required with an objective of both solving the problem technically and communicating the risk effectively. Risk communication techniques are a learned skill and careful thought and planning should be given to how a situation will be communicated from the ...
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Gretchen Stup of DVC and Kevin Raum of Coridium Advisors presented an online webinar to project managers to discuss the tools to identify, assess, mitigate, prepare for, track, and communicate project and program risks on March 11, 2010.
DVC and Coridium Advisors developed this presentation to:
- Share our experiences and lessons from the successful implementation and application of a risk management framework
- Provide an overview of the basic principles of Risk Management
- Provide ...
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Retsch Sample Prep Article:Spotlight 13/2/08 11:00 Page 1
The successful use of spectrometers in the analytical laboratory requires an understanding of the method and profound practical experience. Everyday routine often does not leave the users enough time to develop and optimise the methods. Some analysis technologies require elaborate external trainings of the laboratory workers which delays the use of the instruments and reduces their acceptance among the users.
X-Ray Fluorescent Analysis ...
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Size reduction of elastic plastics with volatile components
Neutral-to-analysis sample preparation for the detection of PAH and phthalates
Polynuclear aromatic hydrocarbons, also known as PAH, are used as plasticizers in many caoutchouc products such as, for example, rubber grips of tools. Some PAH have a proven carcinogenic effect on humans; that is why there are critical limits for the maximum concentration in consumer products. Phthalates are used as plasticizers in plastics such as PVC. ...
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An Oracle White Paper Updated January 2008
PLM technology ensures FDA compliance for medical device companies by providing comprehensive content to support management decisions.
EXECUTIVE OVERVIEW In the medical device industry, efficiently meeting U.S. Food and Drug Administration (FDA) requirements is a key to business success. Product lifecycle management (PLM) technology ensures FDA compliance integrity by providing comprehensive content to support management decisions across the ...
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The Astro Pak Corporation Technology Group performed a study to determine the efficacy of a gel-based citric acid chelant passivation agent on welds and heat affected zones. Questions regarding this type of passivation arise from data developed in experiments using commercially available citric acid solutions, which demonstrate that elevated temperatures are necessary for adequate passivation of weld areas to occur when citric acid is the primary passivation agent. Citric acid gel passivation ...
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Within the past several years there has been enormous innovation in the way workflow solutions are designed and built. In the past, using a process-oriented strategy was only successful under certain conditions as it was unable to adapt to situations that involved complex business rules. Many large corporations became frustrated by the failure of process improvement projects and resorted to using traditional application development techniques. In response to this limitation, the software ...
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Ion Database: Mass Spectrometry of Intact Microbes Ionization and Analysis by MALDI-TOF MS Martin A. Winkler, Ph.D. Available in an Amazon Kindle edition at Amazon.com Database Format, © 2009 by Martin Winkler Las Cruces NM 88005 2009
I. Introduction 2 II. Database: Ions sorted by m/z 3 III. Database: Ions sorted by Bacterial Species 12 IV. Database: Ions sorted by Reference 21 V. Matrices 30 VI. References 31
INTRODUCTION The following database of ions was compiled from peer-reviewed ...
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Profiling of impurities in biopharmaceuticals and their associated intermediates and excipients is a regulatory expectation. Since residuals are typically present at low levels in difficult sample matrices, development and validation of assays can be quite challenging. Matrix types can vary greatly due to the fact that sampling at a variety of process steps is required to accurately monitor throughout the production process.
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Apomorphine (5,6,6a,7-tetrahydro-6-methyl-4H- dibenzo[de,g]quinoline-10,11-diol) is a dopamine receptor agonist under development for the treatment of erectile dysfunction.The purpose of this study was to characterize the in vitro metabolism of apomorphine by hepatocytes from human, rat, and dog. Solutions of 14C-labeled and nonradiolabeled apomorphine were incubated with primary hepatocytes at 1, 2, and 4 hours. Samples of the incubation media were analyzed by HPLC with radiodetection. ...
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Vessel Preparation Cleanliness of the bottles is critical. Common tissue culture glassware cleaning procedures may be inadequate. Included in these instructions are suggested roller bottle cleaning protocols.
Sterilization Autoclave the bottle and cap as a unit with cap loosened to allow venting. Exhaust autoclave slowly, allowing bottles to cool before removing from the autoclave. Rubber liners can become detached if caps are tightened while bottle is still hot or autoclave is exhausted to ...
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Incremental sensors are used in a wide range of industrial settings wherever displacement, angle, linear or rotational speed, or other time-based physical quantities are to be measured.
Resolution is critical in control, and other precision angular applications, such as machine tooling and differential rotational speed measurements. Enhancements of the signal resolution can also be achieved by using a second incremental signal track. The most common technique, of multiplying the two tracks, ...
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Sequential Function Chart to PLC Ladder Logic Translation
This whitepaper describes a procedure for translating a state transition diagram or sequential function chart into a ladder diagram. Ladder diagrams are available on almost all programmable logic controllers (PLC) but writing large programs with complex state-based behavior in ladder diagrams is cumbersome. Instead, the program can be designed with a state transition diagram or sequential function chart and then, if a direct method of ...
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Accurate measurement of immune activity in relation to therapeutic dosing is an important part of many clinical trials, yet is poorly addressed by traditional techniques. Typical immune activity monitoring is performed using isolated leukocytes or even sorted sub- population culturing methods followed by an analytical measurement. These methods require the shipment of intact blood samples to a cell culture lab plus extensive manipulation that leads to alteration of the in vivo physiological ...
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Structural elucidation of impurities during the development of pharmaceutical products is very important. While NMR and other techniques can be used for this purpose, the mass spectrometer is the primary means of conducting structural analysis. In order to do this, high mass accuracy with MSn fragmentation data is absolutely necessary.
The acid degradation products of reserpine were used as model reaction products and impurities of pharmaceutical products, and were analyzed using an ...
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Antibody arrays are solid matrix assays designed to simultaneously monitor changes in the expression or post-translational modication of multiple cellular protein targets. The multiplexing capabilities are possible due to the “printing” of individual antibodies at precise and dened positions (or coordinates) on the matrix. These arrays offer a rapid and economical way to identify kinase pathways or molecules before targeting them for further study using more focused techniques.
The ...
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Apomorphine is under investigation for the treatment of male erectile dysfunction.The disposition and metabolism of apomorphine were investigated after a single subcutaneous dose of [14C]apomorphine (0.34 mg apomorphine base/kg) to a bile duct-cannulated male dog. A total of 92.2% of the administered dose was recovered: 0.1% in plasma, 38.2% in bile, 51.2% in urine, 2.1% in feces, and 0.7% in cage wash.The radioactivity in plasma reached a maximum (190 ng/g) at 100 minutes postdose. Unchanged ...
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In its response to the cacophony of demands for cost-effective, innovative medicines, the biopharmaceutical industry has a unique chance to influence the U.S. health care landscape. The traditional model of pharmaceutical R&D in which a steady stream of broadly indicated blockbusters gave market-based rewards is a rapidly fading memory. While products are becoming more targeted to smaller patient populations, companies are simultaneously under pressure to demonstrate the relative value of their ...
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Chemical cleaning and passivation treatments on stainless steel tubing and equipment are an important aspect in the preparation of surfaces used in corrosive and critical environments. The formation of a higher chromium to iron (Cr/Fe) ratio in the passive layer will result in improved corrosion resistance and lowered rates of iron oxide formation (rouge). Clean process and transfer system surfaces are required to maintain purity of processes and products. A corrosion resistant surface insures ...
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Flow cytometry has replaced the Ham test as the gold standard technique for diagnosing patients with Paroxysmal Nocturnal Haemoglobinuria (PNH). This report highlights the significant contributions flow cytometry has made in defining phenotypes of PNH.
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The FDA has been focusing effort into evaluation of potential adulteration of drug products due to contact with packaging and closure systems, sample delivery devices and components utilized in the manufacturing of the product. Packaging includes components such as vials, caps and stoppers. Drug delivery devices include nebulizers, syringes, medical devices and various types of inhalers. Components utilized during the product manufacturing process include filters, tubing, fittings, connectors, ...
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The world has changed significantly in the past few years. Devastating terrorist acts and threats, the seemingly increased frequency of widespread power grid disruptions, and the emergence of regulatory requirements for infrastructure protection are all placing stringent, yet necessary, data protection requirements on many organizations. Regardless of the industry, as more and more businesses operate in a 24/7 environment — especially large enterprises where global operations are the norm — ...
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Contents Introduction ........................................ ........................................ ........................................ ...........1 Why Is $/MB a Wrong Metric? ........................................ ........................................ ..........................1 What are TCO and ROI? ........................................ ........................................ ..................................1 Why Should Hitachi Data Systems Customers Care about Storage ...
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Data Migration Best Practices and Recommended Storage System–based Data Migration Techniques White Paper
By Patrick Allaire, Justin Augat, Joe Jose and David Merrill
Executive Summary Forrester 2007 research has shown that in excess of 70 percent of enterprise IT budgets is devoted to maintaining existing infrastructure. Organizations need to accelerate innovation and reduce operating expenses to increase their competitiveness or maintain their current market position, CIOs are under pressure ...
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FDA Accredited Persons Third-Party Inspection Program (TPI) To ensure that appropriate medical device manufacturing conditions and controls are in place, the U.S. Food, Drug and Cosmetic Act established a requirement that the FDA inspect manufacturers of Class II and III Medical Devices at least once every two years. Due to limited resources and significant growth of the Medical Device Industry, the FDA has difficulty meeting this demand.
The need for additional inspection resources has ...
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Genomic Antibody Technology™ The Best Tool for Antibody Research
Antibodies are widely used today for diagnostic and therapeutic research of proteins and associated diseases. The race for publications in the academic realm and pursuit of new drugs in the pharmaceutical industry produce a compelling necessity for efficient products. One major challenge of antibody research is the poor quality and design of antibody reagents. The process of designing antigens in order to generate and ...
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Point Of Care Testing in Clinical Trials – Page 1
Point of care (POC) testing is diagnostic testing performed promptly and conveniently in the vicinity of the patient, avoiding the often lengthy procedure of sending samples to be processed in a central laboratory. This gives rise to the alternative names of near‐patient and bedside testing. The requirement for POC testing is increasing, with the global POC testing market predicted to rise from $12.8 billion in 2008 to $17.8 billion in 2014 ...
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Part 2 Why Products Get Contaminated and What To Do About It.
Part 1 of this article discussed basic microbiology related to the manufacturing plant environment and consumer product formulations. Part 2 will discuss what to do when a finished product contamination occurs, and suggest how to investigate and track the problem. The article will also provide some tips on how to come to a final resolution when a contamination has occurred.
There are numerous ways that product contamination may be ...
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Microalbuminuria is an important and well established biomarker in patients with type 2 diabetes, due to its association with progressive renal disease. However, recent studies suggest that microalbuminuria may be considered as an independent marker for cardiovascular disease in patients with hypertension as well as diabetes(1,2,3) the prevalence increasing with age and duration of hypertension.
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In CRM at the Speed of Light: Essential Customer Strategies for the 21st Century, Paul Greenberg says usability “is perhaps the most important factor related to systems that you are going to install at your company. Usability needs to be considered a major design factor and is certainly a component of total cost of ownership.”1 At Sage, we certainly agree. Usability is a cornerstone in creating the user experience of our products—and productivity is the impact.
The Usability Professionals ...
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The advent of bubble elimination in a prefilled syringe offers many advantages worth exploring prior to deciding how a product is to be packaged for clinical studies or commercial distribution. This technique further enhances the benefits of prefilled syringes. Prefilled syringes vs. vials have become the container of choice for parenteral drug delivery. The increase in their use is directly correlated to changes in the healthcare industry. Some of the main advantages of prefilled syringes are ...
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It is a universal truth that research, development manufacture and formulation of potent active pharmaceutical ingredients (APIs) and products requires both “hardware” ( facilities, equipment and engineering controls) and “software” (programs, practices and procedures) to adequately protect personnel and the environment. When employing third party contracting organizations, there is a need to evaluate safe processing with the same rigor as other aspects of drug development, such as quality ...
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High-throughput and virtual screening are widely used to discover novel leads for drug design. On examination, many screening hits appear non-drug-like: they act noncompetitively, show little relationship between structure and activity, and have poor selectivity. Attempts to develop these peculiar molecules into viable leads are often futile, and much time can be wasted on the characterization of these “phony” hits. Despite their common occurrence, the mechanism of action of these promiscuous ...
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The last decade has seen rapid technological progress but with increasing demands for safe and efficacious drugs, technological solutions that reduce the barriers to clinical success will be of more interest than those that simply shift the bottlenecks and necessitate new compromises in the discovery and development process.
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Common literature methods for determining formalde- hyde in air and water are based on derivatizing formalde- hyde first, by the use of either 2,4-dinitrophenylhydrazine (DNPH) or 2,3,4,5,6-pentafluorobenzyloxyamine (PFBOA) and then quantitating the resulting hydrazone or oxime. We report general procedures for the derivatization and determination of total extractable formaldehyde as well as leachable formaldehyde in hydroxypropyl methylcellulose (HPMC) capsules. Trapped formaldehyde in HPMC ...
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Environmental monitoring programs require the rapid and accurate Environmental monitoring programs require the rapid and accurate id of microorganisms. Fungal species are typically identification f iiFl i til tifi ti identified microscopically or by sequencing the D1 D2 region of the py y qg g identified microscopically or by sequencing the D1-D2 region of the large ribosomal subunit and comparing resulting data against a large ribosomal subunit and comparing resulting data against a validated ...
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In dozens of industries and in millions of applications around the world, dangerous chemicals are transferred from their original shipping containers into smaller jugs or buckets or applied to other end-use processes. Historically, the predominant dispensing method in many of these applications has been through an open system where the liquid is poured out of the container. With a poured system, the container is often flipped on its side and the liquid is poured into a secondary container. The ...
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Conducting comprehensive metabolism studies has long been an essential component of a preclinical drug development program. However, numerous factors — including the increased development of protein-derived drugs and the expanded interest in the role of metabolites in safety assessment — are having a significant impact on the regulatory mandates, scope of studies and methodologies employed. In addition, increased scientific and agency scrutiny pertaining to the bioanalytical method validation ...
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Supramolecular Structures of Polyoxomolybdate-Based Giant Molecules in Aqueous Solution
Department of Physics, BrookhaVen National Laboratory, Upton, New York 11973
Since the early explorations made by C. W. Scheele and J. J. Berzelius over two centuries ago, the nature of molybdenum blue solutions has remained a fascinating enigma for inorganic chemists.1 While it is well-known that these solutions are prepared by partially reducing MoVI in acidic aqueous solutions, major breakthroughs in ...
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Process variability is a leading cause in biopharmaceutical batch failure and impacts the value and profitability of the industry. Thermo Fisher Scientific controls inherent variability through the use of the Thermo Scientific Antaris line of Fourier transform near-infrared (FT-NIR) spectrometers.
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Development and manufacturing of recombinant-protein–based vaccines has in the past few years become very similar to that of other well-documented and well-characterized biological drugs. For investigational vaccines, chemistry, manufacturing, and controls (CMC) information is critical for a successful regulatory filing. The process development and CGMP manufacturing of a recombinant protein drug is on the critical path toward clinical phase 1 dosing and safety studies as well as ...
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What is an antibody? An antibody is an immunoglobulin protein, secreted by B lymphocytes, that is present in serum or body fluid and combines specifically with an antigen. Antigens are classically defined as any foreign substance that elicits an immune response. An antigen that produces an adaptive immune response after injection into an animal is an immunogen. Immunogens can be designed so that antibodies are generated against specific proteins. Because antibodies can be made against specific ...
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If designing and implementing processes that are efficient, successful and adaptable is an art, conforming to these processes to rigorous U.S. Government acquisition requirements is a science. While these points may appear deceptively simple, it has taken the combined effort of dozens of dedicated team members--from both government and industry--to arrive at these "a-ha" moments.
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This article describes the performance testing of a downflow booth in accordance with the ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment.
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Effcient, nonselective methods to obtain DNA from the environment are needed for rapid and thorough analysis of introduced microorganisms in environmental samples and for analysis of microbial community diversity in soil. A small-scale procedure to rapidly extract and purify DNA from soils was developed for in-the-eld use. Amounts of DNA released from bacterial vegetative cells, bacterial endospores, and fungal conidia were compared by using hot-detergent treatment, freeze-thaw cycles, and bead ...
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Single-use, disposable products were first introduced to the biomanufacturing industry about a decade ago. Until recently, single-use manufacturers had to extol their benefits and virtues to convince biomanufacturers to consider trying them. However, today’s growing biopharmaceutical product diversity, increasing demand, and high development costs are forcing an increasing number of life sciences companies to incorporate single-use, disposable technologies into their biomanufacturing
production ...
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The enormous advances in biological technology over the past four decades have led to a profound change in how information is processed; conceptual and technical developments in experimental and molecular biology disciplines such as genomics, transcriptomics, proteomics, metabolomics, immunomics, and countless other "omics" have resulted in a veritable sea of data with the potential to radically alter biomedicine. The discipline of bioinformatics has emerged to capture the information stored ...
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The word biocompatibility refers to the interaction between a medical device and the tissues and physiological systems of the patient treated with the device. An evaluation of biocompatibility is one part of the overall safety assessment of a device. Biocompatibility of devices is investigated using analytical chemistry, in vitro tests, and animal models, in vivo tests. The biocompatibility of a device depends on several factors, including:
the chemical and physical nature of its component ...
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The selectivity of LC/MS/MS yields chromatograms appearing deceptively clean. Interferences such as plasticizers and matrix components can adversely affect quantitation via ion suppression. Co-eluting and/or isomeric metabolites in incurred samples can also interfere with quantitation. An LC/MS/MS assay for a drug and one metabolite (M1) provides a case study demonstrating ways to locate and handle various potential interferences.
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Diethyl oxalate is an important molecule with various applications including: total synthesis,1 biochemistry,2 materials science,3 and combinatorics.4 While unlabeled diethyl oxalate is commercially available5 and its synthesis has been reported,6 few attempts have been made to synthesize isotopically labeled (i.e. 13C or 14C diethyl oxalate). Furthermore, the few reported syntheses of 13C and 14C radiolabeled diethyloxalate involve several (i.e. 3-5) steps or result in low yields.7 Diethyl ...
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Thermo Scientific FAST GC columns will save you time and money by utilizing state-of-the-art technology available in modern GC's.
Ability to deliver equivalent resolution compared with conventional length and diameter columns in shorter analysis times.
The major advantage of FAST GC columns is their ability to deliver equivalent resolution compared with conventional length and diameter columns in shorter analysis times. Often run times can be reduced by 50% using these columns.
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Solutions for purification of Fc-fusion proteins. Applying platform processes to complex fusion molecules made up of different structures can lead to unexpected results. This paper discusses a unique engineered protein, EA2, that does not fit into an overall process platform. With a molecule this complex, none of the potential purification steps functioned as expected. What developed was quite different from that initially envisioned.
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Pilocarpine belongs to a class of medications known as cholinergic parasympathomimetics and is a naturally occurring alkaloid in the leaves of South American shrub Pilocarpus jaborandi. Its chemical structure is presented in Figure 1.
Pilocarpine C11H16N2O2 Exact Mass: 208.12
Figure 1. Chemical Structure of Pilocarpine
Sample cleanup was accomplished using an automated liquid-liquid extraction of 0.2 mL aliquots of human plasma. An isocratic HPLC method (5-6 minutes run time, 0.25-0.50 ...
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The coatings industry has undergone tremendous changes in the
last decade, largely as a result of the public’s rising interest in
home, garden and lifestyle improvements. There is now a need for
specialized products that cater to niche applications, and the
coatings industry has had to expand its knowledge to keep one
step ahead of consumer demand. The understanding and
application of scientific principles during the production process is
critical, and one of the most important of these is ...
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Labtronics Inc. has been providing laboratories with instrument interfacing solutions since 1986. During that time we have accumulated valuable experience implementing, training and consulting with over 6,000 customers around the world on all aspects of instrument interfacing in the lab.
Out of that experience, we have developed a clear understanding of what it takes to plan a successful project for interfacing laboratory instruments with LIMS.
At first glance, the task may seem pretty ...
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