Featured Bioprocessing Editorial
After Decades Of Biomanufacturing Workforce Development, What’s Next?
We have seen exponential growth of the biotech industry in recent decades. Companies have struggled to find qualified workers. To close that workforce gap, we need to leverage the lessons from successful biomanufacturing training programs and consider new approaches.
4 Focus Areas To Modernize Your Cleaning Validation Strategy
The traditional outlook on cleaning validation might look inexpensive and safe, but it can lead to serious problems in the long run. To modernize your cleaning validation strategy for 2023, here are four areas to focus on.
6 Strategies To Protect Your Biologics Supply Chain In 2023
Instead of automating everything — which costs a lot and doesn't solve every problem — drug makers should focus on building scalable, need-specific supply chain operations. This article discusses supply chain resilience strategies biotech companies can reasonably control.
How Do Cell & Gene Therapy Requirements Differ Between FDA & EMA?
Let's examine the similarities and differences between how the FDA and the European Medicines Agency approach cell and gene therapies. Where do the regulatory perspectives align and where do they diverge?
Considerations For Microbial Enumeration Methods When Working With CDMOs
In microbial enumeration testing, the product-specific interferences are addressed during method development. The execution can vary between laboratories. This article examines general considerations, membrane filtration, and the pour plate method.
The Holistic Guide To Supply Chain For Cell & Gene Therapy Startups
How does the cell and gene therapy supply chain team stay ahead of the expected changes and respond at the speed the developing program expects? Supplier selection, raw materials, built-in quality, warehousing and logistics, and traceability are all covered in this article.
EMA's Revised GMP Annex 1 Addresses Common Global Challenges for Sterile Products
The new EMA GMP Annex 1, “Manufacture of Sterile Medicinal Products," is in line with other international regulations, e.g., ICH and PIC/S. FDA involvement in its writing is a clear indication that the contents will be the FDA position in general terms. Fortunately, the annex contains many checklists to help you assess and remedy your systems.
What's Behind The ASTM E3263 Standard Revision?
ASTM has published the revision of ASTM E3263 Standard Practice For Qualification Of Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues. This article, written by the ASTM revision team, explains the reasons behind the revision and delves into the key updates.
Frequent Deficiencies In GMP Inspections, Part 3
Don't let cleaning and disinfection methods work against you. Without a system to track cleaning chemicals and equipment, how do you know they haven't expired?
Defining The RNA Therapeutics Industry In 2023
Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.