Bioprocessing White Papers
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What's Next For Our Evolving Workforce?
6/29/2022
Today's evolving workforce comes with challenges. Continue reading to learn about three industry survival methods that when applied can ensure generational workforces are blending cohesively: engagement, culture, and communication.
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From Bench To Billions: Facilitating Scale-Up Of Adherent Cultures For Cell And Gene Therapies
6/27/2022
We review what researchers should consider when they are creating a risk-mitigating adherent culture process for cell and gene therapy scale-up.
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The 4 Phases Of CAPA Maturity: A Guide To Mastering Quality Event Management
6/22/2022
This brief provides an understanding of the key role corrective actions/preventive actions (CAPAs) serve in regulatory compliance and product quality improvement and offers a blueprint to help develop your own effective and optimized strategies.
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Steps To Successfully Complete An FDA Inspection
6/20/2022
We outline the steps to take before, during and after an FDA inspection so the FDA’s call to schedule an inspection doesn’t have to be a nightmare scenario.
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A Guide To Pharmaceutical Quality Management
6/16/2022
Despite the inherent challenges of connecting quality and compliance data, there are tools that can help you to ensure quality's connectedness and central bearing.
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Optimization Of Hydrogen Peroxide Decontamination
6/6/2022
Understanding critical influencing factors of hydrogen peroxide bio-decontamination is key for reliable process parameters.
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GMP-Validated Adventitious Virus Testing By Next Generation Sequencing
6/6/2022
Gain required knowledge related to the involved regulatory authorities and scientific technologies and disciplines: Next Generation Sequencing (NGS), Bioinformatics and Computer System Validation (CSV).
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Why More Drugs Than Ever Are Approved Through 505(b)(2)
6/6/2022
Discover how bringing a modified version of an existing drug to market through 505(b)(2) can offer a clear path to approval, a differentiated product, and at least some period of marketing exclusivity.
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What Every Clinical Team Should Consider Before Developing The Next Protocol: Putting Volunteers First
6/3/2022
Even though everyone applauds the renewed focus on patients as a positive development, some say it is time for biopharma companies to turn their attention to another audience: clinical trial participants.
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Comparator Local Sourcing Strategies: Leveraging Advantages And Avoiding Common Pitfalls For Clinical Trials
6/3/2022
The growing demand for comparators is causing many supply chain managers to explore available sourcing options. Explore alternative local sourcing strategies, including advantages and disadvantages.