Bioprocessing White Papers

1. 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.

2. 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.

3. 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.

4. 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.

5. 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. 

6. Optimization Of Hydrogen Peroxide Decontamination 6/6/2022

   Understanding critical influencing factors of hydrogen peroxide bio-decontamination is key for reliable process parameters.

7. 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).

8. 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.

9. 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.

10. 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.