Featured Bioprocessing Editorial
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CDMO Selection: 7 Steps To Find Your Best Fit
11/11/2024
Selecting the right CDMO for your project is essential. Here is a practical 7-step process, along with key considerations and pitfalls to avoid along the way.
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A Risk-Based Approach To Filter Integrity Testing Annex 1 Requirements For Biologics DS
11/8/2024
How do the principles of filter integrity testing described in EudraLex Annex 1 apply to low bioburden drug substance manufacturing? And how can using a risk-based approach help?
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The Complex Regulatory Landscape Of Flow Cytometry For Cell Therapy
11/8/2024
Flow experiments must be controlled to produce consistent data. With a gush of new technology, regulators have put more scrutiny on flow cytometry-based approaches.
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Commissioning & Qualifying: Facility Considerations For Tissue Engineering
11/7/2024
This article provides an overview of the facility considerations for tissue engineering. It includes a comparison of a bulk biologics facility, which aids the discussion.
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Biopharmaceutical Fermentation Systems' Growing Role In Modern Medicine
11/6/2024
Bioreactors, culture media, growth factors, and sensors are essential to foster microbial or cell growth in optimal conditions.
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How Ring's Single-Capsid Protein Approach Optimizes Viral Delivery
11/5/2024
Complexity and manufacturability have an inverse relationship. Ring’s platform seeks to simplify highly complex gene therapy production by making the most of biology.
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Peptide Synthesis: New Market Research
11/3/2024
Peptide synthesis is used to create new vaccines, medications, and enzymes. This article provides an overview of solid phase and liquid phase synthesis as well as new market research.
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Maintaining Harmony With Your CDMO Using 'The Middle Way'
10/31/2024
Sponsor and CDMO relationships are fertile ground for conflict. A measured approach can mitigate disruptions with troublesome contractors and high performers alike.
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A Comprehensive Guide For Supplier Quality Agreements
10/29/2024
This overview of SQAs includes a handy matrix template, which is useful for determining who is responsible for managing specific responsibilities.
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Computer Systems Validation Pitfalls, Part 2: Misinterpretations & Inefficiencies
10/29/2024
In part 2 of the authors' series on computer systems validation pitfalls, they cover misinterpretations and unnecessary "nice to haves" that waste execution efficiencies.