Featured Bioprocessing Editorial

1. How To Implement Continuous Process Monitoring Of Validated Processes 10/28/2020

   It is time to consider augmenting your validated pharmaceutical, medical device, and tissue production processes, including processing, packaging, and labeling, with continuous process monitoring to ensure continued compliance with established specifications and requirements if you do not want to be cited by the FDA.
   
    

2. Mapping The Development Of A Biosimilar Candidate: Analytical & Regulatory Decisions 10/27/2020

   This article, the first in a two-part series, details the biosimilar development path to identify and evaluate critical quality attributes for both the candidate biosimilar and the reference product, along the regulatory timeline.

3. Mammalian Biomanufacturing Industry Supply & Demand Trends 10/26/2020

   While capacity will increase over the next five years, demand for capacity, pandemic aside, will increase at a slightly faster rate, allowing for some short-term loosening of capacity constraints, but after 2024, capacity tightening may occur.

4. Biologics Manufacturing In China: Competition Heats Up Among CMOs & Their Clients 10/23/2020

   Significant growth of outsourced commercial-scale manufacturing is projected for the near future in China, though certain bottlenecks remain.

5. How Do FDA, MHRA, & Russia’s Drug Inspectorate Evaluate & Escalate Inspection Findings? 10/21/2020

   Representatives from the Russian Federation State Institute of Drugs and Good Practices, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), and the U.S. FDA share their processes for evaluating and escalating inspection findings to determine if regulatory action is needed.

6. COVID-19 Vaccine Manufacturing Challenges Spark Surge In Outsourcing Deals 10/19/2020

   As the pharma industry scrambles to develop one or more viable COVID-19 vaccines, the greatest hurdle to immunizing the world’s population is the manufacture of billions of doses in parallel. In response to this challenge, vaccine developers are signing an unprecedented number of outsourcing agreements with CMOs and other service providers.

7. A Quality Agreement Primer: What To Include & Who To Assign It To 10/16/2020

   Part one of this three-part series on quality agreements discussed identifying key risks in partnering with contract companies and working with vendors. Part two explored the regulations and enforcement activities associated with quality agreements. In this final part, we examine what to include in quality agreements and who should be responsible for the assigned tasks.

8. How To Improve FDA Inspection Readiness & Outcomes By Mining Publicly Available Data 10/14/2020

   Now that we have years of real-world regulatory outcomes data available, why are we ignoring their power to serve as a corrective lens for our interpretations of the law?

9. Does Your Pre-COVID Data Governance Pose A Threat To Data Integrity? 10/12/2020

   Pandemic disruption presents a clear and present danger to data integrity. Assessment of agreed data standards, confirmation of conformance to filed information, and general attention to details may be compromised in the rush to gather, analyze, and understand pandemic-related information.

10. A Quality Agreement Primer: Reviewing Regulations & Enforcement Activity 10/9/2020

    This is part two of a three-part article on quality agreements. Part one discussed identifying key risks in partnering with contract companies and working with vendors. This second part explores the regulations and enforcement activities that apply to quality agreements.