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| Multispecific molecules bring added complexity to downstream purification—think incorrect chain pairings, aggregation, fragmentation, and lower yields. Join Bioprocess Online Live as we explore how developers are addressing these challenges to achieve high purity and efficient processes. Gain insights into key considerations for downstream teams when designing purification strategies for these advanced biologics. Registration is free thanks to the support of Thermo Fisher Scientific. |
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FOCUS ON QUALITY/ANALYTICAL METHODS |
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| Is It Ever Too Soon To Start Your Performance Testing Assessment? | Article | By Mike Ulman, West Pharmaceutical Services, Inc. | Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of Critical Quality Attributes (CQAs), and performing design verification testing. |
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| Antibody-Drug Conjugates – Catalysts For Chemistry | White Paper | Curia | Review the complexities of developing linkers – chemical moieties which attach a drug payload to an antibody – and considerations when identifying a CRO for ADC research and development. |
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| HCP Detection And Quantitation | e-book | By Ellen Williams, Cygnus Technologies Inc. | Learn the ins and outs of host cell proteins (HCPs), HCP ELISA, and HCP contaminants, as well as how to improve your recombinant protein production. |
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QUALITY/ANALYTICAL METHODS SOLUTIONS |
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By John W.M. Claud and Michelle L. Butler, Hyman, Phelps & McNamara | Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for defensive and offensive strategies. | |
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| Regulatory Considerations For First-Time Drug Developers | Article | Cytovance Biologics | Navigate the challenging path from concept to clinical reality by partnering with an experienced CDMO that can provide the regulatory, clinical, and CMC expertise needed to move your therapeutic forward and bring it closer to patients in need. |
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| The Case For A Facility Monitoring System | White Paper | By Tim Russell, TSI Incorporated | Facility monitoring software with OPC UA client/server functionality makes great business sense. Learn how monitoring leads to reduced waste, improved yield, higher quality, and increased profits. |
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