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The IKA CMX 2000Newest Innovation Of Solid-Liquid Mixers – Outstanding Powder Wetting In Batch Process
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Demystifying Systems Integrators and Automation Design Engineers: Understanding the DifferencesWhen you’re partnering with a design firm to support your product development and manufacturing needs through automation, it’s important to decide whether you should work with a systems integrator or an automation design engineering firm.
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Biosimilars: Is It Worth Taking On The Regulators?The different pathways to regulatory approval of a biosimilar vary worldwide, ranging from no pathways at all in some developing countries, to the complex and precise mechanism that exists in Europe.
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Addressing the Key Pitfalls Hindering Technology Transfer SuccessIn this article, the potential pitfalls of technology transfers are discussed as well as ways to ensure a smooth transition.
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Improving IR Spectroscopy as a Tool for Biopharmaceutical AnalysisA recent innovation in infrared spectroscopy, Microfluidic Modulation Spectroscopy has been shown to improve characterization of secondary protein structure.
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SMEDDS incorporated polymer matrix: A floating dosage form solution for drugs with poor gastric solubilityA new kind of gastro-retentive dosage form for drugs with poor aqueous solubility was developed and evaluated, with the aim of achieving gastro-retention.
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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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Suppositories: The Incomplete StoryA reference book omits important information and ignores advanced testing procedures.
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Master File Submission of StructuresThe SD File format offers benefits for KASA and cheminformatics to support regulatory submissions.
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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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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.
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Handling Challenging Powders in Tableting OperationsTests evaluated commercial rotary tablet presses to see how effectively they deal with problems such as poor flow, overlubrication, and capping.
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Digitalization of QbD Risk AssessmentsQuality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. Their digital transformation can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.
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Dissecting Dissolution TestingAdvances in dissolution testing equipment are helping to meet user demands to a certain degree; however, more innovation in the space may be necessary for novel therapies, such as biologics.
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Seven Trends Shaping the Future of Pharmaceutical Formulation DevelopmentEmerging new technologies and disruptive manufacturing concepts are providing new opportunities for pharmaceutical companies.
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Strategic Insights for 2025Alec McChesney (BD Director, SCORR Marketing) discusses goal setting and alignment between life sciences marketing and business development teams.
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Master File Submission of StructuresThe SD File format offers benefits for KASA and cheminformatics to support regulatory submissions.
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EPCAM: A Strategy to Enable Manufacturing-Process Control TransformationEnterprise process control and management (EPCAM) is a new strategy for healthcare manufacturers based on recent process-control breakthroughs in the electronics industry.
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2020 Bio/Pharma Virtual Congress*** Live: Wednesday, November 11, 2020 | 8:30 AM EDT – 4:00 PM EDT *** 2020 Bio/Pharma Virtual Congress: Join Pharmaceutical Technology® and BioPharm International® for this online event that will explore the latest developments in formulation, manufacturing, and innovative drug dosage forms, as well as detailed discussions about crucial topics impacting the industry. ***On demand available after final airing until 11/11/2021
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Considerations for Monoclonal Antibody Bioprocess and Manufacturing ValidationRegulatory, analytical, and process concerns must be taken into account.
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MOBILIZE YOUR DATA. MODERNIZE YOUR LAB.Thursday October 27, 2022 at 11am ET | 10am CT | 8am PT When it comes to freely accessing and sharing lab data, there’s a lot working against you out there. To create infrastructure that truly mobilizes your data and modernizes your lab, you need a new kind of solution.
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Lab Digitalization: From Source to ScientistIntegrating digital technologies into lab environments can ease workflow and enhance data capture for researchers.
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Lean Compliance And Adopting A True Risk-Based Approach To ValidationWith the increasing need for businesses to reduce costs and demonstrate value, there is a requirement to look at all aspects of bio/pharma drug development and manufacturing to achieve efficiency improvements.
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The New EMA Bioequivalence Guideline: Key ConsiderationsA new guideline for conducting bioequivalence studies was adopted by the CPMP in January and it becomes fully effective as of August 2010.
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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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Focusing on Effectiveness for CAPAsCompliance can be greatly improved by concentrating on the basic elements of CAPA investigations, advises Kate Rice, global quality systems manager, Nelson Laboratories, and Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates.
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Comparing Methods for Determining Out-of-Trend Stability Test ResultsThis article describes in detail how simulation was used to compare the statistical techniques used to determine out-of-trend (OOT), which is crucial to avoiding out-of-specification (OOS) events for drug substances and products.
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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.
