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By Tim Sandle, Ph.D. | In April, the European Medicines Agency issued a draft of a new guidance document titled Reflection paper on a tailored clinical approach in biosimilar development. The public consultation runs until Sept. 30, 2025. | |
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By Jim Morris, IQS Consulting | Why is it that managers at pharma manufacturing sites continue to be frustrated by what could be labeled as “avoidable” human errors, and what can companies do about it? Let's investigate. | |
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By Jayen Diyora, Max Chen, Sarthak Pandey, and Andrew Walsh | Surrogate surfaces, or “coupons”, are used to simulate pharmaceutical manufacturing surfaces or medical devices for the performance of swab and rinse recovery studies. Experts from The Center for Pharmaceutical Cleaning Innovation provide insights for proper care and handling. | |
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By Kerim Ozbilge, EY | From traditional chemotherapy to advanced immunotherapies and nanotechnology, pharma/biotech companies must overcome logistical hurdles that affect their oncology products' availability and quality. | |
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