Authors
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Tools and Technologies for Robust Method Lifecycle Management in Liquid ChromatographyAdvanced LC technologies can streamline the review process for LC equipment maintenance.
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Points to Consider for Knowledge Management AccelerationQuality quartets support an integrated and stable combination of commissioning and qualification and quality risk management processes.
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Converting Injectable Therapies to Combination Drug-Device ProductsThe author describes how to seize market opportunities while navigating the requirements of both drug therapies and delivery devices.
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Selecting a CMO Partner for Sterile Injectable ManufacturingVetting contract fill finish manufacturers is about more than their capacity. Jubilant HollisterStier advises on what to look for in a sterile fill finish partner.
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Assessing Manufacturing Process RobustnessA structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.
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A Step Closer to Closure in BioprocessingAs biopharma anticipates the “Facility of the Future,” a definition of what closed processing is, and quantification of its value, can be helpful information.
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Right the First Time: Bioreactor Scale and Design TranslationThe authors give an overview of scaling approaches and present good scaling practices for the biopharma industry.
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ACS-Grade Reagents’ Database LaunchedThe complete online database of ACS Reagent Chemicals is now available.
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Strategic Changes to a Legacy Cleaning Approach Result in a More Sustainable ProcessIn this article, the authors explored the elimination of a water rinse and blow down following the caustic wash step, examining potential safety considerations, the effect on the quality of the cleaning process, and the potential benefit of implementing this change.
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Introducing the BIOne 10L Single-Use BioreactorThe BIOne 10L SUB is highly innovative with expanded processing capabilities, ideal for scale-down modeling, material generation, and process optimization.
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Purification of Protein by HIC: Mechanistic Modeling for Improved Understanding and Process OptimizationIn this article, a simple chromatographic model is proposed that is capable of predicting the impact of pH and ionic strength on HIC chromatograms.
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Reimagining Affordable BiosimilarsAdvances in preclinical development play a crucial role in reducing cost for developing biosimilars.
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Transforming Process Development with AI: Success Stories from mAbs to Emerging ModalitiesWebinar Date/Time: Thu, Thu, Apr 18, 2024 11:00 AM EDT
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Addressing the Training Gap for Single-Use TechnologiesWorkforce training is crucial for biopharmaceutical manufacturing.
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Scaling Manufacturing Processes Using Single-Use TechnologiesAlthough new single-use technologies offer the flexibility needed to overcome several challenges in ATMP production, there are many considerations and hurdles manufacturers must be aware of when scaling.
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New Developments in Plasma ProteomicsA single protein or gene expression product can exist in multiple proteoforms due to alternative splicing, point mutations, post translational modifications and endogenous proteolysis.
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Improving Vector Yield at Scale: A Fresh Approach to Cell Lysis Quality AssessmentOptimizing the harvest of viral particles is important for the yield and purity of the final product.
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Continuous Preparative SEC for Purification of “Difficult-to-Manufacture” Proteins–A Feasibility StudyContinuous SEC was shown to increase productivity with the same product quality and yield.
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Supply Chain Challenges Creating Hurdles to COVID-19 Vaccine ProductionThe availability of materials is a critical factor when it comes to vaccine capacity.
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Analysis of Risk-Based Quality Management ApproachThis white paper investigates best practices and tangible benefits associated with a risk-based quality management (RBQM) approach to clinical trial management.
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Oligonucleotide Therapeutics: Chemistry and therapeutic modalitiesThursday, November 3, 2022 Session 1: 10 am CST | 11 am JST (APAC) Session 2: 1 pm GMT | 2 pm CET (EMEA) Session 3: 2 pm EST | 11 am PDT (Americas) (Americas)Register for our educational webinar series presented by Professor Tom Brown, University of Oxford and learn more about the advances in oligonucleotide therapeutics and diagnostics!
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Commercial Production of Gene Therapies Using Suspension or Adherent Cell LinesThis article will explore the traditional path from the laboratory to the clinic and how the fixed-bed technology provides an alternative solution to meet commercial demands.
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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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Overcoming Engineering Challenges to Enable Commercial Scale mRNA Vaccine ManufacturingThis article provides an overview of solutions to address key challenges facing vaccine developers or CDMOs wishing to build their own commercial-scale mRNA production facilities.
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Predicting Extractables and Leachables from Container StoppersData from migration kinetics studies can be used to develop models that predict levels of leachables and extractables at different temperatures and time points.
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Steps to Ensure Quality Production of BiopharmaceuticalsThis eBook highlights key considerations for navigating the supply chain as newer biotherapeutic molecules drive growth and support the innovation and manufacture of newer biologics.
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Digitalization of QbD Risk AssessmentsThe digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.
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TEM Is the Ideal Complement to In-Vitro Assays and Molecular Techniques in Determining the Microbiological Safety of Biological ProductsTransmission Electron Microscopy’s key advantages is its unbiased nature, making it an ideal complement to in vitro assays and molecular techniques in determining the microbiological safety of biological products. The Eurofins Electron Microscopy laboratory can aid in evaluating the size, shape, and purity of viral particles, as well as assessing their capsid content.
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Considering a Coating Technology as an Alternative to Silicone OilA coating technology for a staked needle prefillable syringe reduces the potential risks associated with silicone oil as a lubricant.
