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Designing An Effective PAT-Driven Scale-Up Of Lyophilization ProcessesThis article examines the difficulties in designing lyophilisation processes that can be faithfully scaled up to production volumes and suggests the most effective ways in which this can be achieved.
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Manufacturing Considerations for Sourcing GMP Fermentation ServicesThe authors describe the critical aspects of an ideal fermentation services provider.
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A Novel, Enhanced, and Sustainable Approach to Audit Trail ReviewEli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
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Colorless and Soluble High-Performance PFAS-Free Polyimide Materials from Aliphatic AnhydridesSara Greco, R&D Chemist at Valsynthese, part of the SSE Group, covers the beneficial properties of polyimide materials and the key role that aliphatic anhydrides play in the enhancement of those properties.
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Growth in Cell and Gene Therapy MarketBiopharma focuses on streamlining biomanufacturing and supply chain issues to drive uptake of cell and gene therapies.
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Detecting Apparent Total Nitrosamine Content in Pharmaceutical DrugsScreening for apparent total nitrosamine content with a thermal energy analyzer offers a rapid way of identifying contaminated drug products.
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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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How Integrated Project Delivery Enables Speed: A Phase-By-Phase GuideBy eliminating the waste involved in traditional approaches to project set-up and execution, integrated project delivery helps innovators in the European life sciences market meet their fast-track delivery targets.
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A Harmonized Approach to Performing a Risk-Based Audit Trail ReviewThe IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.
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Single-Cell Proteomics Enable Advancements in Disease ResearchInnovations in single-cell analytics have advanced the progression of cell biology research, which has brought new understanding of disease mechanisms.
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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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Process Impurities Clearance in BiologicsThis white paper discusses developing optimal platform analytical methods with partner CDMOs for effective process impurities clearance in biological drug substances.
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Simplify Patient-Centered Clinical Trials With Trusted Data Foundation and Machine Learning PracticesA common obstacle life sciences organizations face during clinical trials is obtaining the right patients and promoting consistent engagement. High-quality data and technology can be used to streamline clinical trials and enable omnichannel experiences.
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Training Centers and eCommerce: A Look Into Federal Equipment Company’s Pharma InnovationsHow Techceuticals, PharmParts, and smart auction strategies are ushering in a new era of efficiency and innovation for CDMOs
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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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The Importance of Titrations in Pharmaceutical Analysis: From the Basics to the Modern Method***Live: Wednesday, February 24, 2021, 1pm EST | 10am PST | 6pm GMT | 7pm CET*** Titration plays an important role in pharmaceutical analysis. Despite the recent attention given to chromatographic methods, several applications are only feasible by titration, making it a fit-for-purpose method for many analytes. For example, distinguishing between carbonate and bicarbonate or monobasic and dibasic phosphate salts can only be accomplished by titration. *** On demand available after final airing until Feb. 24, 2022.***
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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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Drug Substance Starting Material SelectionThe authors review the current regulatory framework for the selection of drug substance starting materials.
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Advances in Radio-Frequency Transdermal Drug DeliveryA microelectronic system based on radio-frequency (RF) cell ablation addresses limitations of other transdermal drug-delivery methods. This system expands the transdermal spectrum to include the delivery of water-soluble molecules, peptides, proteins, and other macromolecules.
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Dissolution Testing For Inhaled DrugsAlthough there are no regulatory requirements or established pharmacopoeial techniques for the dissolution testing of inhaled drugs, such testing can potentially open up the opportunity to tailor formulation properties.
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The Ever-Changing World of Extractables and Leachables: Lessons learned and future challengesOctober 4, 2021 at 3pm BST | 10am EST | 4pm CEST Join global industry and regulatory experts as they discuss current hot topics in extractables and leachables (E&L) testing for pharmaceuticals, biopharmaceuticals and medical devices.
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Bringing Collaboration to the Horizon Once MoreUK scientists are once again able to participate in the Horizon European research programme thanks to a deal struck in 2023.
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Pharmatech Insights – The Difference Between Compliance and QualityCompliance and quality are not the same thing. While compliance means manufacturers demonstrate they meet regulatory requirements, quality is foundational to patients’ confidence in the safety and effectiveness of their medications.
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A New Route to Pharma GDP Compliance and StandardizationA consensus-based approach to GDP lies at the heart of a new industry-wide program seeking to rationalize, standardize, and harmonize the adherence to pharma transportation norms and regulatory guidelines.
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Overcoming Data Gaps in PharmacovigilanceBy leveraging certain strategies, organizations can effectively close data gaps and achieve more accurate and effective machine learning models in pharmacovigilance.
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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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Managing the Complexity of Modern Sterile Product DevelopmentsManaging the intricacies of sterile product development is imperative for successful and compliant outcomes.
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Peer-Reviewed Topical Review: The Importance of Quality in Corrosion-Resistant Alloys in Biopharmaceutical ManufacturingIn this topical review, the authors discuss the rationale behind microstructural requirements for biopharmaceutical equipment and problems that may be encountered during the fabrication of high-performance corrosion-resistant equipment.
