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| In biologic-based analytical CMC drug development, one of the most challenging obstacles in entering Phase II clinical trials is the cell-based potency assay. Common problems with CMC regulatory submissions include inadequate methods, lack of appropriate potency assays, or method description issues. The complexity of developing and validating a relative potency assay is often underestimated, given the need to balance MOA demonstration with minimizing variability. Learn more about how to develop a CMC Relative Potency Assay. |
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By J. Casey Lippmeier, senior vice president of innovation, Conagen | Let’s be honest — CHO is an expensive, inefficient, and pervasive way to make mAbs. Emerging and evolving alternatives discussed here include microbial systems, which tend toward better efficiency. |
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Few drug discovery and development concepts are as hyped, and as such, draw as much polarity from drug developers, as machine learning and artifical intelligence. One company on the bullish end of the spectrum is Flagship Pioneering's Generate: Biomedicines, which bills itself at the "intersection of machine learning, biological engineering, and medicine." |
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| Evaluating Biologics CDMOs: Tips For Crafting An RFP | Article | By Andrew Handorf, Scorpius BioManufacturing | Delve deep into the transformative power of a well-designed RFP, one that transcends mere cost-efficiency to unearth hidden needs and bridge critical expertise gaps within your organization. |
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| Is Mannitol Hemihydrate Detrimental To Protein Stability? | White Paper | Simtra BioPharma Solutions | Maintaining an amorphous excipient matrix is crucial for protein stability. Learn about the importance of storage conditions in managing mannitol hemihydrate dehydration and ensuring protein stability. |
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| Are Bioreactors The New ‘Fish Tanks’? | Article | By Marcelo Szpilman, Eppendorf SE | By exploring innovative approaches to scaling up animal cell growth in cutting-edge bioreactor systems, foodtech companies are poised to offer healthier, safer, more sustainable fish for consumers. |
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| From Bench To Batch: Strategies For Scaling HPAPI Production | Webinar | Ajinomoto Bio-Pharma Services | Highly potent materials bring additional challenges to manufacturing processes. Examine considerations for optimizing HPAPI production methods to reduce risk and deliver therapies to patients with speed. |
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| Advantages Of Working With An Embedded CMO | Article | By Ania VanDyke, AbbVie | An embedded CMO offers many advantages over other CMO models, not least its access to the extensive capabilities and know-how of the parent organization. |
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| What analytics technologies, tools, and instruments do biopharma developers consider requisite in the buildout of a modern biologics/ATMP, manufacturing facility? How are those tools enabling the analytics and controls that are requisite to continuous manufacturing and advancing the industry toward “biopharma 4.0?” Join Bioprocess Online Live on March 27th to find out! Registration is free thanks to the support of Culture Bio. |
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