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Leverage the Power of Recipe-Driven Execution and StandardizationStandardized manufacturing through a Recipe-Driven Execution environment and digital twins minimizes effort duplication while simplifying operations, harmonizing production processes, and accelerating speed to patient.
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Large-Scale LNP Process Conversions: The many hurdles of LNP scale-up and what to considerLipid nanoparticle (LNP) formulation development begins on a small scale, often with homemade or benchtop setups, using syringe pumps and easily accessible micro-mixing systems. Once a promising formulation has been identified, the next step is to transition to standardized large-scale impingement mixing systems, such as the high flow T-mixing pumps that were used to produce the COVID-19 vaccines (Sealy 2021). Formulators need to consider a number of factors when scaling up novel LNP systems. These include flow rates that affect LNP particles, solvent removal, risk factors when changing equipment, and the impact of tangential flow filtration sensitivity. In this technical note, we discuss these factors and what needs to be considered when developing a cost- and time efficient large-scale process.
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Mitigating the Risk from Excipient VariabilityThis article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.
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How a Lack of Critical Thinking is Hindering Regulatory ComplianceWhy critical thinking must be applied before technology to ensure regulatory compliance.
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Determining Efficacy and Proper Methodology in Cleanroom CleaningIt is vital to consider optimal cleaning and disinfection practices when operating a cleanroom.
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Ensuring API Quality Through a Robust Manufacturer Approval Process PodcastIn the current industry landscape, API quality can make or break a drug product. LGM Pharma stands out by treating supplier relationships as strategic partnerships rather than transactions. In this interview with Pharmaceutical Technology, Shailesh Vengurlekar and Diem Hoang share LGM’s rigorous, multi-step process for evaluating, approving, and continuously monitoring API manufacturers—highlighting the company’s collaborative approach that prioritizes transparency, and patient safety.
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Report From: IndiaWhile the world pulls itself out from one of the worst crises in decades, Indian pharmaceutical companies are trying to capitalize on falling company prices by increasing their takeovers.
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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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Continued Process Verification Is Critical in Pharmaceutical ManufacturingContinued process verification ensures pharmaceutical manufacturing stays in control through data analysis, trend detection, and lifecycle monitoring.
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Using Modified QbD to Develop a Novel Pediatric Formulation of EzogabineThe epilepsy treatment, Potiga, has been used off-label to treat specific types of epilepsy in some children. However, it has never been formally evaluated in pediatric clinical trials. Using a modified QbD approach, the authors have developed a granular formulation suitable for use in clinical trials involving infants and children.
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The Role of Flavoring Agents and Taste Modulation Strategies in Drug DevelopmentThis article investigates the role of flavoring agents and taste modulation strategies and describes how these solutions can help to mask unpleasant tastes, improve palatability, and, ultimately, increase patient compliance to drive better treatment outcomes.
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Building a Greener Supply Chain: Key Considerations for Cold ChainWith the majority of large pharmaceutical manufacturers aiming for carbon neutrality by 2030, reusable packaging remains a largely untapped approach in achieving measurable ESG gains.
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A Flexible Future: Adopting Reclosable, Flexible Pouches for Pharmaceutical PackagingFlexible packaging benefits align with challenges including an aging population, compliance requirements, e-commerce, serialization, and a need for recyclability.
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Strategies for Overcoming Common Challenges in Tech TransferThe complexities of tech transfer may be overcome by data-driven approaches, digital tools, and effective communication.
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Rentschler Biopharma: A 50-year Legacy of Exceptional CDMO ExpertiseExplore how Rentschler Biopharma duels biopharmaceutical innovation, spanning from pioneering biological products to cutting-edge cell and gene therapies
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Accelerate Clinical Trial Success with Genomics ExpertsWebinar Date/Time: Thu, Mar 2, 2023 1:00 PM EST
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Moisture-Activated Dry GranulationMoisture Activated Dry Granulation (MADG) was developed in response to the difficulties experienced with wet granulation, in terms of endpoint, drying and milling. Wet granulation process endpoint is very sensitive to granulation time and shear. The wet granules need to be dried to a narrow range of moisture contents, which is difficult. The dried granules need to be milled, but the milled granules often have either too many fines or too many coarse particles (or both) - an undesirable bimodal distribution.
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Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in BiomanufacturingDetermining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.
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Addressing Developmental Challenges of Gene Therapy Viral VectorsSignificant improvements have been developed to tackle the challenges in viral vector manufacturing at each stage.
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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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Multivariate data analysis easily retrieves insight from a wealth of dataStatistics are often viewed as confusing and complicated, but multivariate data analysis (MVA) methods can be used to amass knowledge simply.
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Dissolution’s Next Challenge–NanoparticlesNanoparticles are increasingly being used to overcome low solubility and poor permeability.
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Inside USP: USP Metals Testing: A Workshop ReportAttendees at a recent workshop endorsed new methods to detect metals in drugs, dietary supplements, and food ingredients.
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The Role of Dendrimers in Topical Drug DeliveryThis review provides an update of how dendrimer technology is being applied to the development of novel systems for various topical delivery applications.
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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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Due Diligence Assessment of CMC ActivitiesFor planned acquisitions or licensing, a careful analysis of CMCl factors is vital to ensure no problem areas are overlooked.
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Navigating a New Standard in Microbial Protein ExpressionKBI Biopharma has created a platform E.coli resulting in a PURE, efficient platform expression strain - PUREcoli™ - to reduce impurities and reach higher titers.
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Trends and challenges of biopharma manufacturingThe whole pharma/biopharma industry is under pressure to deliver cost-effective new drugs; however, the number of new drug applications is getting lower as the size of investment is increasing.
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How Pure is Pure? Understanding Reagent Purity GradesAs interest in cell and gene therapies continues to grow, the need for safe and consistent reagents to support research, development, and manufacture efforts also increases.
