Authors
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Talking Strategic Development with Simtra at DCATRay Guidotti, Chief Operating Officer at Simtra BioPharma Solutions, talks about the company's strategic development and how it supports customers with a focus on excellence.
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Ongoing Analytical Procedure Performance Verification—Stage 3 of USP<1220>Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.
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QRM, Knowledge Management, and the Importance of ICH Q9(R1)This paper reflects upon the past 15 years of experience in the application of QRM and KM within the pharmaceutical GMP environment.
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Application of machine learning tools for predicting impact of punch cup depth on tablet cappingWe have proposed a comprehensive capping index parameter which is a ratio of compact anisotropic index to material anisotropic index. This study will help to design or select right tooling for successful tablet manufacturing.
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Viewpoint: Precompetitive Collaboration Drives Pharma Industry InnovationThe IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.
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EU Anti-Counterfeiting Legislation On Its WayIn order to combat the threat of counterfeits in Europe, the EU's current anti-counterfeiting directive is being amended.
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Revitalizing Quality Management Processes through DigitalizationEradicating paper-based workflows and standalone solutions operating in isolation provides a good starting point to update quality management processes.
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Dielectric Spectroscopy: Choosing the Right ApproachThis tutorial paper is meant to aid in dielectric-sensor selection
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The Next Frontier in Pharmaceutical OutsourcingWhile companies today outsource numerous processes, from early development through to manufacturing, there are still many opportunities to realize the full potential of outsourcing services.
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Coating and Taste Masking with ShellacThe authors describe the background and applications of fully formulated aqueous shellac for film-coating systems.
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Evaluating the Impact of Fatty Alcohols on Permeation of Clotrimazole from Topical CreamsStudy results indicate that fatty alcohols may plausibly enhance the skin permeation of clotrimazole.
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Using Robotics in the Aseptic Manufacturing Facility of the FutureSeveral steps need be taken to achieve lights-out, fully automated operations.
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Specification Equivalence—A Practical ApproachIn this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
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Optimizing Loss-in-Weight Feeding of Poorly Flowing MaterialsPrior to use in a continuous manufacturing system for oral solid dosage forms, loss-in-weight feeders need to be tested and validated to understand the performance capabilities of a given material–feeder combination. In this article, the proper strategy for set-up and optimization of a loss-in-weight feeder is demonstrated for a range of materials. The optimized set-up of the feeders was demonstrated to provide suitable performance for even the most challenging, poorly flowing materials.
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Capturing The Advantages Of Co-CrystalsHow can crystal engineering and pharma sciences be combined to enhance the clinical performance of drugs?
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Shining a Light on the Long Shadow of Subjectivity in Quality Risk ManagementThis article explores the emergence of subjectivity in ICH Q9 (R1).
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The Value of Pharmacopeial Reference StandardsThis article provides an overview of the key risks that can be associated with the use of secondary reference standards (RS) and illustrates scientific challenges associated with transitioning from pharmacopeial RS to secondary RS.
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Selecting a CMO Partner for Sterile Injectable ManufacturingFor tech transfer of sterile injectables, vetting CMO partners means more than availability of facilities or the equipment, CMO partners should offer end-to-end support
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Early-Stage Considerations for the Manufacture and Delivery of VaccinesAlthough vials and prefilled syringes have different advantages, both find use in vaccine fill/finish.
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Validating Single-Use SystemsThere are a number of validation approaches that can be adopted for single-use systems - all of which incorporate an established approach.
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Clinical And Cost Considerations Of Developing A BiosimilarBoth biosimilar and generic drugs have an abbreviated approval process; however, the clinical trial requirements differ enormously.
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A Four-Phased Approach for Evaluating a Quality Risk Management ActivityUsing the four-phased method to assess QRM can ensure continual improvement and that regulatory requirements are met.
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Method Development and Impurity Control in Late-Phase API ManufacturingOnce APIs move into later phases of development, an advanced impurity control strategy is vital and demands a comprehensive analytical methods approach.
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Running a Marathon in Flip-Flops – Part 2: The Value of Incorporating Prerequisites into Equipment QualificationEquipment qualification is a critical step in ensuring that a product or service is provided accurately and consistently with regards to manufacturing and testing. The time-saving attribute of adding prerequisites to a qualification program, along with the benefit of gaining the ability to track and trend problem areas, make the addition both worthwhile and cost-effective.
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Manufacturing OSD Forms: Key Trends Shaping the IndustryThe latest manufacturing technologies are essential for helping pharmaceutical formulators meet up-and-coming trends in OSD treatments.
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Reducing Packaging Costs for Prefilled SyringesBlow-fill-seal (BFS) technology presents an economical option for single-unit dose delivery of vaccines.
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QMM for Pharmaceutical Manufacturers– Implications for Drug Manufacturers, API Suppliers and Contract ManufacturersQMM principles and practices can positively influence a sustainable drug supply and bolster the bottom-line of drug manufacturers, API suppliers, and CMO/CDMOs.
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QMM for Pharmaceutical Manufacturers– Implications for Drug Manufacturers, API Suppliers and Contract ManufacturersQMM principles and practices can positively influence a sustainable drug supply and bolster the bottom-line of drug manufacturers, API suppliers, and CMO/CDMOs.
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Formulation of Sustained-Release Ketorolac Tromethamine PelletsThe authors evaluated the effect of polymer composition on the drug-release profile and the effect of storage conditions on dissolution characteristics.
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Stability Studies: An Essential Step for Quality Management in Drug DevelopmentSufficient stability studies show a drug product meets regulatory requirements, therefore ensuring the drug reaches the patients who rely on it.
