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| Webinar: Building an Effective Contamination Control Strategy for Sterile Filtration | It is important that end-users understand what factors to consider when executing a CCS for sterile filtration and the types of risk assessments that should be conducted. Join us on August 13th with Cytiva as we discuss filter selection, integrity testing, filter validation and considerations for performing pre-use post sterilization integrity testing (PUPSIT). Click here to learn more. |
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FOCUS ON DOWNSTREAM MANUFACTURING |
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By Laura I. Salazar-Fontana, Ph.D., and Daniela Drago, Ph.D., RAC, NDA Partners | Variability is inherent to biologics manufacturing. The trick is to catch it quickly and prevent product quality drift. That’s where the new ICH Q14 comes in. |
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| Unpacking mAb Manufacturing Purification Challenges | Article | By Brian O’Mara, Scorpius BioManufacturing | Although cell and gene therapies and ADCs are dominating the headlines, mAbs remain the largest class of biopharmaceuticals. Gain expert insights into the challenges and solutions of mAb purification. |
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| Predicting Viral Clearance In Downstream Process Development | Application Note | By David Cetlin, Cygnus Technologies Inc. | Optimize purification steps and determine with confidence whether process steps and parameters are effective before investing resources in regulatory supporting validation studies using live virus. |
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| Complex protein-based therapies don’t play by the same process-engineering rules as small molecules and traditional biologics. They require developers to see the unforeseen and embrace new roles and responsibilities in sourcing raw materials and outsourced expertise. Successful developers can’t let this winding road slow their time to IND. Join Bioprocess Online Live on August 8th for an interactive discussion on early workflow considerations for complex protein-based therapeutics. Supported by Thermo Fisher Scientific. |
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DOWNSTREAM MANUFACTURING SOLUTIONS |
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| Webinar: Accelerating mAb Process Development in the Growing Therapeutics Market | Join us on August 20th as Thermo Fisher Scientific scientists explore the latest strategies and advancements in early stage mAb up- and downstream process development. They will share valuable insight on stable CHO cell line development for mAb production, media and feed screening strategies to meet clone specific nutritional needs, and techniques to enhance purification process development by high-throughput screening. Click here to learn more. |
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| Connect With Bioprocess Online: |
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