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FOCUS ON FACILITIES DESIGN |
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By Matthew Pillar, Editor, Bioprocess Online
| The wave of ADC (antibody-drug conjugate) development and manufacturing activity we’re currently witnessing, and importantly, the HPC (high-potency compounds) comprising the payloads in these therapies, demand thorough assessment of development and manufacturing facility design. |
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| Reducing Risks In Your SIP Validation Cycles | Article | Mesa Laboratories | Utilizing tape for positioning during Sterilize in Place (SIP) validation can introduce numerous issues. Explore the top eight reasons why tape should be avoided during SIP validation cycles. |
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FACILITIES DESIGN SOLUTIONS |
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FOCUS ON PROCESS ENGINEERING |
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A conversation with R. Tod Urquhart and Alessandro Pelizzi | Unique identifiers on glass vials could solve a host of problems. ISPE developed a new guide to help manufacturers apply them on primary parenteral containers. |
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| Considerations In Depth Filter Scale-Up | Webinar | Cytiva | Explore study findings aiming to assist process development scientists and engineers in understanding the structure of depth filter capsules, identifying key parameters for development, and more. |
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| The Aqueous Cleaning Handbook | E-Book | By Michael Moussourakis, Jeff Phillips, Stacy Silverstein, and Malcolm McLaughlin, Alconox Inc. | This handbook is intended to assist laboratory and manufacturing plant scientists and engineers in accurately selecting and maximizing the performance of aqueous cleaners and systems. |
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| Welcoming The "Era Of ADCs" | Article | Cytiva | Dr. Loretta Itri sat down to explore the promise of TRODELVY®️ and other antibody-drug conjugates as transformative treatments for a range of malignancies and intractable diseases. |
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| Distinguish And Quantify Particles In Adenoviral (AdV) vectors Capsids | Application Note | By Julia Talarek and Shawkat Hussain, Jenner Institute, University of Oxford, UK and Ivor Crooks, Matthew Powell-Grabaskey, and Matt Ranaghan, Refeyn | Explore the application of macro mass photometry in analyzing AdV vectors, distinguishing between empty and full viral capsids, and accurately measuring the proportion of full capsids present. |
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| Developability Assessment Of Three Therapeutic Antibodies | Poster | By Tao Bi, Yesenia Aguilar, Paul Phelan, et al., JOINN Biologics | This poster reviews studies for three monoclonal antibody drug candidates utilizing a panel of small scale, fast, and predictive tests used to evaluate therapeutic antibodies’ developability. |
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PROCESS ENGINEERING SOLUTIONS |
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