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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.
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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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Optimization of Clarification Step in Pneumococcal Polysaccharide Conjugate Vaccine Manufacturing: Evaluating the Performance of Depth FiltersThis research focuses on refining the clarification step by assessing the performance of various depth filters. The study explores both conventional cellulose-based and innovative synthetic depth filters, utilizing pneumococcal fermentation harvests from two challenging serotypes.
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Application Note: Scaling up HEK cell culture process from 250mL to 5L bioreactor with consistent performance in Culture Biosciences cloud-connected bioreactorsDiscover how our latest study demonstrates consistent performance across 250mL and 5L bioreactors, ensuring reliable results at any scale. Dive deeper into optimizing your gene therapy processes with scalable, data-driven solutions.
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Purification of Antibodies Using Novel Convecdiff Membranes Part 2: Robust Performance at Comparable Product QualityIn part 2 of this article, results from the testing of a next generation convecdiff membrane are discussed.
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Best Practices for Tech Transfer to Avoid Manufacturing PitfallsEnsure the success of clinical biomanufacturing programs by focusing on key tech transfer practices from the sponsor, commercial, scientific, and program management stakeholders.
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Final Thoughts and Looking Forward: The Future of Pandemic PreparednessSustained investment, technological innovation, and collaboration are essential to future pandemic preparedness.
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World Cancer Day: Innovation in the Cancer Treatment PipelineTreatment for cancer continues to drive immense innovation in the drug development pipeline, with advanced cell therapies, vaccines, and ADCs taking center stage.
