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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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New Regulations Influence Design of Bio/Pharmaceutical Manufacturing Facilities (INTERPHEX 2024)As the industry adjusts to new regulations, including Annex 1, bio/pharma manufacturers must rethink facility designs to remain in compliance.
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Plasmid DNA—The Versatile Building BlockPlasmid DNA (pDNA) is a critical raw material for the manufacture of cell and gene therapies. As this market continues to grow, so too does the demand for high-quality pDNA.
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Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based StrategiesMany biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.
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Mitigating Human Error and Supporting Compliance with Smart TechnologyTechnological advances hold promise for mitigating human error in the pharmaceutical industry, especially in quality assurance/quality control, by reducing the incidence of, and risk associated with, mistakes.
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Perceptions and Considerations for Adopting Closed ProcessingThe combination of modular facilities and closed processing offers significant advantages in the production of biopharmaceuticals and is becoming a compelling option for manufacturing.
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A Systematic Evaluation of Risks and Mitigation Strategies for Convalescent Plasma Therapy for COVID-19A task force details its findings of the risks associated with using convalescent plasma using failure mode and effects analysis
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From Conception to Manufacturing. Accelerating Therapies with CuriaIn this podcast, we will explore the advantages of partnering with a Contract Development and Manufacturing Organization (CDMO) to navigate the journey from molecule conception to clinical trials, including the expertise, experience, and preparedness that a CDMO brings to the table. The audience will gain valuable insights into crucial questions such as the optimal stage in the development process to engage with a CDMO, the necessary preparations for a successful collaboration, and whether a finalized molecule is required to initiate discussions with a CDMO. Join Curia’s Director, Process Development Science, Scott Alderucci, who leads the process development group at Curia, a global CDMO offering CDMO expertise for biologics and small molecules.
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Keeping up with New Emerging Analytical TechnologyWebinar Date/Time: Tue, Sep 17, 2024 11:00 AM EDT
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Navigating the Intricacies of Lentiviral CGTsScientists are leveraging ddPCR technology to get an accurate read on viral titer and vector copy number.
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Overcoming Operational and Regulatory Challenges in Autologous Cell-Therapy FacilitiesManufacturers must address scale-out challenges of autologous cell therapy for commercial manufacturing.
