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Current Trends in Host Cell Protein Detection for Biologics ManufacturingIn this paper, the authors lay out some commonly accepted HCP analytical methods, the challenges of HCP assay, and provide recommendations on what can easily be accomplished in-house and when it may be better to outsource.
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Pharmacovigilance Under Scrutiny: Why Companies are Falling ShortDespite pharmacovigilance legislation being in place for nearly a decade, many companies are still struggling to fulfill obligations.
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Compatibility Assessment of a Model Monoclonal Antibody Formulation in Glass and Blow-Fill-Seal (BFS) Plastic VialSee how stability of a formulation in Woodstock Sterile Solutions’ primary container design compares to glass vials.
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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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Developing a Contamination Control StrategyThis whitepaper provides an overview of developing a comprehensive contamination control strategy (CCS), taking into consideration the various aspects of pharmaceutical manu
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The Impact of SARS-CoV-2 on Biomanufacturing OperationsThis article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.
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Developing and Executing a Campaign to Boost Web Traffic by 85%Read about how we helped The Clinician increase users to their website by 85%, new users by 92%, and sessions by 94%
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The Necessary Role of Integrity Testing in Laboratory Sterility FiltrationAssessing the integrity of filter membranes is critical for maintaining sterile filtration operations in laboratories.
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Printable Medicines: A Microdosing Device For Producing Personalized MedicinesThe authors describe a new method for the production of personalised medicines utilising ultra-precise microdrop printing technology.
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Driving Innovation in Drug Delivery: Stevanato Group’s Integrated Solutions for Evolving Patient NeedsInnovative drug delivery solutions are evolving due to advances in biotechnology and the demand for biologics, focusing on user-friendly devices that improve patient compliance and support high-viscosity, large-volume treatments and various therapies.
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An Alternative to the USP Disintegration Test for Orally Disintegrating TabletsThe authors propose an alternative to the USP disintegration test method. The method embraces physiological conditions of the oral cavity, as a screening tool for developing ODT products.
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Thermogelling Matrix-Containing Platelet Lysate-Loaded Elastic Liposomes as a Potential Treatment of WoundsThe purpose of this article was to demonstrate the application of a new thermogelling matrix in the healing of wounds.
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Preformulation in Theory and PracticeAn ambitious survey of characterization techniques presents current information.
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Maintaining a Strong Company Culture Through Difficult TimesSocietal™ CDMO's J. David Enloe and Erica Raether discuss the fundamentals of maintaining a strong company culture during times of change.
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Report From: China, May 2008Although there have been recent setbacks for China with regard to exported products, the country has made substantial strides in its pharmaceutical industry over the past few years. Intense competition and a series of new regulations seem to be moving the country into a period of recovery.
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ROSS Ribbon Blenders - Video in ActionROSS Ribbon Blenders meet the toughest standards for quality and long-term performance. Known worldwide for heavy-duty robust construction, high quality materials and fine craftsmanship, these blenders are available in a variety of customizable configurations ranging from laboratory sizes to 1000 cubic feet. We pay close attention to every detail in design and fabrication, a commitment that translates to higher production value for the end user.
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Characterizing A Nasal Spray Formulation From Droplet To API Particle SizeThe way in which a suspension nasal spray product interacts with the body depends not only on the droplet size of the delivered droplet, but also on the particle size of the suspended API.
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From the Chairman: Technology Advances Foster New TherapiesTechnology advances foster new therapies.
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Developing an Optimized Risk Assessment Portfolio—The Quality Risk Management Master PlanA thoughtfully constructed QRM Master Plan translates the strategy and enables a risk-based approach.
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Are You Ready for REMS?A book offers a detailed introduction to the new area of risk evaluation and mitigation strategies.
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Analytical Strategies for Cell and Gene Therapy DevelopmentDeveloping bioassay methods requires a new approach for cell and gene therapy drug development.
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Liposome ExtrudersLiposome extruders are mainly used for the liposome formulation and achieving uniform size distributions. It is an ideal instrument to generate nanoscale liposome formulations, and to prepare exosomes and artificial cell membranes. By utilizing the tracked-etched filter membranes, the liposome extruders are capable
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Outsourcing: The Indian PerspectiveIndia has evolved from a low-cost region to an area with extensive technical capability and high quality standards.
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The Benefits and Challenges of PEGylating Small MoleculesPolyethylene glycol (PEG) conjugation is a highly effective technical and commercial strategy to develop macromolecules. The authors explain the benefits and process of PEGylation and how it may be applied to small molecules.
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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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Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms: Part 1AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
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Setting Cleaning Validation Acceptance Limits for Topical FormulationsThere is a need for current cleaning validation methods to be used for topical formulations. The authors highlight the issues and challenges encountered.
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Pelletization: Revolutionizing Drug Formulation and DeliveryPelletization, a popular oral drug delivery method in pharmaceuticals and nutraceuticals, offers numerous benefits. This article delves into the critical parameters for formulation development and technological consideration in pelletization, elucidating its significance in advancing pharmaceutical solutions.
