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Establishing Systems Suitability and Validity Criteria for Analytical Methods and BioassaysEnsuring reliable analytical methods and bioassays requires a well-thought-out strategy for evaluating method validity and systems suitability.
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CPHI Frankfurt: Selecting the Right Outsourcing Strategy and PartnerSponsors should explore key considerations ahead of choosing a new outsourcing partner.
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The Growing Importance Of Release Liners In Pharmaceutical ManufacturingWith the increasing importance of novel dosage forms, the use of release liners as components of transdermal delivery systems, oral thin films and buccal mucosal systems is on the rise.
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Global Warming Heats Up Need for Malaria VaccineWith economics and politics in the way, can we defeat the malaria epidemic before it defeats us?
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Improving Patient Access Through the UK IDAP SchemeThe IDAP pilot scheme is designed to accelerate access to innovative medical devices and is a pioneering legislative proposal in the UK medical device space.
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Exploring Best Practice Tech Transfer Methods for CGTsBest practice methods for the tech transfer of CGTs can increase process and analytics robustness while remaining scalable.
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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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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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New Technologies For Pharmaceutical Manufacturing: Addressing Cost, Containment And cGMP RequirementsNew isolator and disposable technologies are set to assume a greater role in pharma manufacturing, according to a recent conference in Germany.
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GMP/GDP Inspections: Challenges and Opportunities Revealed by the COVID-19 PandemicAn annual survey on inspections and audits has revealed opportunities to use more flexible approaches to optimize processes.
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Pharmaceutical Knowledge Management: Experiences in Drug Development and ManufacturingKnowledge management has gained increasing importance in the pharmaceutical industry over the past 10–15 years
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Collaborative Efforts Address Key Data Integrity ChallengesMaintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.
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The Value of Primary Working Standards in Pharmaceutical Quality ControlIt is argued that orthogonal quantitative methods can be used to establish primary working standards. An example details how to calculate the expanded measurement uncertainty (U) for the certified assay value by considering two orthogonal assay methods.
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The Importance of Continued Investment in R&DThere has been a notable shift in interest for life-science companies over recent months from institutional investors investing through the public markets, but any plans to release further capital will rely on first-rate R&D.
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Accelerate Biomedical and Life Sciences Research and Discovery Processes with the Power of Next-Generation AlWednesday, September 8, 2021 at 8am EDT| 5am PDT| 1pm BST| 2pm CEST AI has opened up an enormous amount of possibilities for biomedical and life sciences organizations to use growing volumes of data to accelerate and improve upon critical processes that can speed time to value and improve patient outcomes. Learn how next generation AI is revolutionizing how these organizations can deliver innovation and value to patients and overcome the constraints of legacy technology, easier and faster than ever before.
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Using Tolerance Intervals to Assess Conformance to RequirementsThe authors introduce the idea of asymmetrical tolerance intervals as an aid in fully assessing product performance relative to product or process requirements.
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Ensuring Stability Excellence for Global Consumer and OTC ProductsWebinar Date/Time: Tue, Jan 31, 2023 11:00 AM EST
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Industrial Applications of Whole-Cell BiocatalysisRecombinant microbial whole-cell biocatalysis is a valuable approach for producing enantiomerically pure intermediates. The authors examine several groups of enzymes using this approach: dehydrogenases, hydantoinases, and acylases.
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Rapid Sterility Methods for CAR T-cell TherapiesA combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.
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Challenges in the Secondary Manufacture of Encapsulated High-Potency DrugsLiquid and semisolid encapsulation using two-piece hard capsules is an ideal drug delivery approach for highly potent compounds and poorly water-soluble drugs. The authors detail the factors to reduce risk when designing and operating a facility for secondary manufacturing of highly potent drugs.
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Latest EU Guidelines For Biosimilars DissectedThe EMA's Guideline on Similar Biological Medical Products provides overarching guidance, but since its introduction a range of more specific guidelines have also been developed.
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Drug Solutions Podcast: Outsourcing vs. Insourcing in Biopharma: Determining the Best Strategy: Part 2In this episode of the Drug Solutions Podcast, Meg Rivers discusses outsourcing strategies in biopharma with Jeff Henderson, key account manager of Vetter.
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Entering New Domains for 3D Printing of Drug Products3D printing of personalized medications is currently possible under existing compounding regulations, offering enhanced process control through automation. But new legislation coming in 2025 will allow 3D printing as part of a distributed manufacturing framework.
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The Role of Dry (Water-free) Process Equipment Cleaning in Continuous Pharmaceutical ManufacturingThe growing use of continuous manufacturing in the pharmaceutical industry merits a review of the application of dry cleaning and sanitization methods, especially for non-sterile oral solid drug product manufacturing of dry powders.
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EU GMP Annex 1 - Impact on Cleaning and DisinfectionAnnex 1 was released in 2022 and has had an impact on cleaning and disinfection. Download this article for more information on how your facility can stay compliant.
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Privacy and COVID-19 Clash, Creating Unprecedented Risks for PharmaTo maintain business continuity and employee safety during the pandemic, many companies have begun tracking and maintaining records of employee health information.
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Extending Shelf-Life With SorbentsExtending a drug product's shelf life while maintaining its strength, quality and purity is a challenge for pharma companies.
