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| Webinar: De-Risking the Aseptic Drug-Filling Process and Optimizing Production | In the aseptic drug-filling process for biotherapeutics, your company may find it challenging to meet regulatory compliance standards, putting the safety and effectiveness of your products at risk. Join us and gain valuable insights into enhancing the efficiency and reliability of the drug product manufacturing process. Learn innovative strategies and best practices from industry experts to refine your pharmaceutical production methods. Click here to learn more. |
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By Hemadri Doma, Tolmar Inc. | Let's dig into key elements of FDA's draft guidance on software assurance, which could reshape the validation of automated data processing and quality system software for pharma/medical device firms. |
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| Upstream Optimization Paved The Way For Full Capsids In AAV6 | Poster | By James Fasano, Azam Hassaninasab, Daniel Kennedy, Theresa Dao, Jay Cai, Omar Matalka, Christine Beaudry, Miranda Williams, Lorenz Ponce, Arianna Spooner, Emily Sinclair, Bojiao Yin, and Mercedes Segura, ElevateBio | Because clinical applications for AAV are increasing rapidly, there is a high demand for further increasing yields as well as product quality, particularly for a higher percentage of full capsids in the final product. |
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| Strategies To Improve Protein A Resin Cost Effectiveness | Webinar | Purolite, An Ecolab Company | Explore innovative process intensification strategies and practical applications to increase resin utility, resulting in improvements in costs and time efficiencies in Protein A affinity capture. |
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| 3 Strategies For Optimal Oversight Of Your Outsourcing Partner | Article | By Stephanie Gaulding, Pharmatech Associates - A USP Company | Building strong relationships with CDMOs and CROs relies on a solid outsourcing framework. Review three key areas that should be built into your outsourcing framework and agreements. |
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| A Playbook For Accelerating Success While Maintaining Quality | e-book | By Martin Gonzalez, Pfizer CentreOne | From the digital infrastructure needed to enable a collaborative approach, to the quality systems and analytical methods, effective tech transfer relies on the careful consideration of a variety of factors. |
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| Β-Glucan As A Process-Related Impurity In Biopharmaceuticals | White Paper | By Soonbin Kwon, Lalit Saxena, Robert Andersson, Jookyung Lee, Jacqueline Lee, and Dongkyu Shin, Samsung Biologics | Explore the sources of Β-glucan, its influence on manufacturing and patient safety, and ways to detect and control its amounts in the finished drug product. |
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| Developability Assessment Of Three Therapeutic Antibodies | Poster | By Tao Bi, Yesenia Aguilar, Paul Phelan, Laura McDevitt, Henry Yong, David Gae, Anjali Patel, Wen-Rong Jiang, Tao He, and Zhiping Yao, JOINN Biologics | Review these studies for three monoclonal antibody drug candidates utilizing a panel of small scale, fast, and predictive tests used to evaluate therapeutic antibodies’ developability. |
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| Trends In Precision Medicine: Cancer | White Paper | Corning Life Sciences | Scientists are working to discover new and effective ways precision medicine can prevent, diagnose, and treat diseases such as cancer. |
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| Quantitation Of Monoclonal Antibodies In Serum | White Paper | Prepared By Beata Talar, Ph.D., Mabion | Monoclonal antibodies (mAbs) are a rapidly growing group of targeted therapeutics. Gain insight into the importance of optimized bioanalytical assay platforms for mAb development. |
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| Highly Reproducible Results With A High-Throughput Bioreactor System | Application Note | By Helen Luo, Firehiwot Tachea, Salvador Mireles, Derrick Wong, Chelsea Edgar, Katie Madler, Matthew Ball, and Will Patrick, Culture Biosciences | Are you looking for ways to reduce bioprocess development time and scale-up? Learn the details behind a high-throughput bioreactor system with the ability to generate high quality, reproducible data. |
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| Mixing Efficiencies For The 100 L HyPerforma Single-Use Mixer | Application Note | Thermo Fisher Scientific Bioproduction | Investigate the mixing efficiency of a next-generation, single-use mixer providing clients with enhanced functionality and ease of use for critical up- and downstream process liquid preparation. |
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