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Together to Minimize Risks - Meeting the Demand for Vigilance
| By APCER Life Sciences
Whether marketing innovative new therapies, biosimilars, or generics, your company's adverse event (AE) reports are in demand. Responding to an expanding matrix of global reporting regulations has been the norm in pharmacovigilance for more than a decade. Even as profit margins shrink, your company must continually submit increasing volumes of AE cases and meet strict timelines to stay in compliance. Now, with increased transparency of safety information, regulatory systems are just the first stop for individual case safety reports (ICSRs).
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Together for Safer Therapies - A Model for Clinical Safety
| By APCER Life Sciences
With profit margins and public trust declining across the life sciences sector, both the funding and the patients needed for clinical studies are becoming precious resources. Companies must gain insights from every data point obtained in every trial - and efficacy is only half of the equation for measuring health outcomes and potential returns.
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Elemental Impurity Analysis in Pharmaceuticals – The Road To Implementation of ICH Q3D
| By Butterworth Laboratories Ltd
Elemental impurities have been a hot topic since 2009 when the International Conference of Harmonisation (ICH) commenced work on a new standard to provide a global policy to limit these impurities in drug products and ingredients. Their guidance document, Q3D, reached step 4 in December 2014, meaning the final draft is recommended for adoption to the regulatory bodies of the European Union, Switzerland, Japan, USA and Canada.
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DryLab®4 - An Overview
| By Molnár-Institute
Exploring DryLab basics, method development strategy and DryLab benefits.
Production & Manufacturing > Manufacturing > White Papers
DryLab®4 - Next Generation in HPLC Modeling
| By Molnár-Institute
DryLab® is the leading software solution for HPLC method development, optimization, troubleshooting, robustness testing and training. With less than 12 experimental runs, DryLab® is the only tool capable of delivering over one million precise chromatograms predictions and display the results in its user friendly interface. Its enhanced features will transform your chaotic method development into a comfortable and streamlined workflow, as well as increasing your productivity.
Production & Manufacturing > Manufacturing > White Papers
Rapid UHPLC Method Development for Omeprazole Analysis in a Quality-by-Design Framework and Transfer to HPLC Using Chromatographic Modeling
| By Molnár-Institute
The aim of this study was to apply quality-by-design principles to build in a more scientific and risk-based multifactorial strategy in the development of an ultrahigh-pressure liquid chromatography (UHPLC) method for omeprazole and its related impurities.
Production & Manufacturing > Manufacturing > White Papers
Minding your Caps and Tails – Considerations for Functional mRNA Synthesis
| By New England Biolabs
Applications of synthetic mRNA have grown and become considerably diversified in recent years. Examples include the generation of pluripotent stem cells (1-3), vaccines and therapeutics (4), and CRISPR/Cas9 genome editing applications (5-7). The basic requirements for a functional mRNA - a 7-methylguanylate cap at the 5´ end and a poly(A) tail at the 3´ end - must be added in order to obtain efficient translation by eukaryotic cells. Additional considerations can include the incorporation of modified bases, modified cap structures and polyadenylation strategies. Strategies for in vitro synthesis of mRNA may also vary according to the desired scale of synthesis. This article discusses options for selection of reagents and the extent to which it influences synthesized mRNA functionality.
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The Benefits of Real-Time Analysis for Process Development
| By Malvern Instruments
While much effort is expended in optimizing commercially operating plant, getting the process 'right first time' can be far more efficient. Real-time analysis of process parameters provides substantial support during development, streamlining and accelerating the evolution of successful process designs. Taking on-line particle size analysis as an example, this paper considers the rationale for investing in real-time measurement for pilot scale work. Case studies illustrate the various ways in which on-line systems promote efficient process development, easing the transition into profitable manufacture.
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Understanding Yield Stress Measurements
| By Malvern Instruments
Many complex fluids, such as network forming polymers, surfactant mesophases, emulsions etc do not flow until the applied stress exceeds a certain critical value, known as the yield stress. Materials exhibiting this behavior are said to be exhibiting yield flow behavior. The yield stress is therefore defined as the stress that must be applied to the sample before it starts to flow. Below the yield stress the sample will deform elastically (like stretching a spring), above the yield stress the sample will flow like a liquid.
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Towards a Unified Biophysical Characterization Platform: Combining Dynamic Light Scattering and Raman Spectroscopy to Determine Protein Structure and Stability
| By Malvern Instruments
The combination of dynamic light scattering (DLS) with Raman spectroscopy has the capability to characterize a wealth of chemical, structural, and physical parameters of therapeutic proteins. Raman spectroscopy simultaneously derives protein secondary structure markers (amide I and III) and tertiary structure markers (aromatic side chains, disulfide bond, hydrogen bonding, local hydrophobicity). These markers can be monitored under controlled conditions by the determination of spectral peak position, shape, and/or intensity. Raman is able to make these structural determinations at formulation concentrations, 50 mg/mL or greater, rather than at the diluted concentrations required by conventional methods, i.e. typically less than a few mg/mL for circular dichroism (CD).
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