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FDA Inspections During COVID-19: A Brave New WorldThis article explores the evolution of FDA’s approach to inspections of drug and biologics manufacturing facilities during the COVID-19 pandemic.
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Biopharmaceutical FrontiersDaniel Galbraith, Chief Scientific Officer (CSO) of Solvias provided a comprehensive picture to Pharmaceutical Technology of the current landscape of cell and gene therapy advancements. The discussion covers important regulatory guidance, technological landmarks, and how Solvias is impacting the current market.
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Packaging for Stability Studies: to Outsource or Not?Developers might invest in small-scale equipment to produce packaging for stability studies in-house, or they might outsource production. Manufacturers should consider the benefits and risks to both approaches.
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Understanding the Benefits of Harnessing Just in Time Manufacturing as a Supply Chain Solution for Managed Access ProgramsChallenges that can prevent sponsors realizing the full potential of managed access programs can be overcome by embracing a just-in-time manufacturing strategy.
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Using Gas Headspace Analysis to Assess Glass and Nontraditional Vial-Closure IntegrityIncreased use of nested and ready-to-use primary packaging has resulted in a need for more validation data on container-closure integrity. This article describes efforts to develop these data for new and traditional containers and closures.
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Highly Efficient Olefin-Metathesis CatalystsThe authors describe the Piers' catalysts and detail latest progress in olefin-metathesis catalyst technology.
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A Big Impact: Trends Shaping Small-Molecule APIs, Excipients, and FormulationsWebinar Date/Time: Thursday, September 21, 2023 at 11am ET | 10am CT | 8am PT | 4 pm BST
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Trends in Peptides and Oligonucleotides: Choosing a Partner CDMOThursday, September 15, 2022 at 4pm ET | 3pm CT | 1pm PT Partnering with an experienced CDMO can support drug developers’ manufacturing needs and allow them to focus on the core of their developments.
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Perceptions and Considerations for Adopting Closed ProcessingThe combination of modular facilities and closed processing offers significant advantages in the production of biopharmaceuticals and is becoming a compelling option for manufacturing.
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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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Advancing the CMC Development of Oncology Medicines***Live: Tuesday, November 17, 2020 at 11am EDT| 8am PDT| 4pm GMT| 5pm CET***Oncology drugs dominate today’s industry pipeline, increasing the pressure on pharmaceutical scientists to get medications to patients as quickly as possible. But does the focus on speed mean sacrifices are made elsewhere in the development plan? Drug developers need to be mindful of the development challenges that come with oncology drug products in order to accelerate to proof-of-concept and onwards towards a successful commercial launch. *** On demand available after final airing until Nov. 17, 2021.***
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Industry Pulse: The “Connected” Pharmaceutical Supply Chain for Resiliency and AgilityThursday, September 2, 2021 at 10am EDT | 7am PDT | 3pm BST | 4pm CEST
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OPTIMIZING VACCINE EFFICIENCY & DOSAGE : SEPARATION & FLOCCULATION TESTINGThis note describes a rapid method for the evaluation of sediment redispersibility in less than 30 minutes using the Turbiscan technology.
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Using Gas Headspace Analysis to Assess Glass and Nontraditional Vial-Closure IntegrityIncreased use of nested and ready-to-use primary packaging has resulted in a need for more validation data on container-closure integrity. This article describes efforts to develop these data for new and traditional containers and closures.
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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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Preformulation in Theory and PracticeAn ambitious survey of characterization techniques presents current information.
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The Pharmaceutical Industry Looks to Reduce Waste by Getting LeanThe low-volume pharmaceutical industry must adapt Lean Manufacturing tools invented for high-volume, single product industries.
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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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Powering Clinical Operations With Knowledge Graphs and LLMs With Merck KGaA, Darmstadt, GermanyWebinar Date/Time: Thu, Mar 13, 2025 11:00 AM EDT
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Advancing Enzyme Analysis Through AutomationPersistent bottlenecks in biocatalyst development can be alleviated through fully automated enzyme analysis.
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Perfecting the Pitch: Learning to Attract Investor FundingStart-ups are plagued with common issues that dramatically decrease their odds of achieving investor funding.
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Implementing Data Integrity Compliance in a GLP Test FacilityConsider how to apply ALCOA+ to a building management system in non-clinical laboratories.
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Is Pharma Doing Enough To reduce The Environmental Impact Of packaging?Generally, the pharma industry isn't doing enough to reduce the environmental impact of its packaging materials, but there are various historic reasons for this.
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Perspectives and Challenges of Nanomedicine in Gene SilencingAdvances in nanomedicine have provided several potential candidates for safe and effective delivery of siRNA.
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Designing Incubators for Cell Therapy ManufacturingControlling conditions and preventing contamination are crucial for cell growth.
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PharmaLex furthers its clinical and regulatory reachMerger with Phlexglobal expands provider’s technological capabilities.
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Enabling the Virtual Human Through Physiologically-based Pharmacokinetic ModelingBasic principles of physiologically-based pharmacokinetic (PBPK) modeling and its impact in streamlining the drug development process are reviewed.
