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By BioPhorum | 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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By J. Morris, IQS Consulting, and D. DeRoo, independent consultant | 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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By Christopher Ohms, Ohms Consulting | Transitioning from clinical-stage operations to commercial readiness is a multifaceted process. Establish compliant and robust distribution systems by focusing on these three areas. |
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| Taking Charge Of Your Stability Program | White Paper | By P. Hamill, Ph.D., A. Glekas, Ph.D., and G. Pirozzi, Ph.D., MilliporeSigma | Conducting stability studies is a critical aspect of the drug development process. Learn how consolidating stability testing with a single partner offers improved efficiency, reduced risk, and more. |
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| Design Verification Testing Of Combination Products | Article | By Mike Ulman, West Pharmaceutical Services, Inc. | Developing a combination product and seeking a list of tests to complete design verification testing? Review the details for planning, design inputs, design outputs, and design verification. |
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| Production Of A Highly Concentrated Monoclonal Antibody | Application Note | By Sandeep Kristiansson, Cytiva | Learn how to achieve a final monoclonal antibody (mAb) concentration exceeding 200 g/L while preserving critical quality attributes essential for therapeutic efficacy and regulatory compliance. |
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