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May 17, 2024 | 
bioprocessonline.com | Erich Bozenhardt |Michael Moussourakis |Jeff Phillips |Stacy Silverstein
FOCUS ON FACILITIES DESIGNAfter decades of helping to rescue biotech and pharma companies from environmental monitoring excursions, Herman and Erich Bozenhardt bring this discussion about specific problems you should avoid. Steps For Proper Cleaning ValidationExamine the steps of cleaning validation for both low-volume and high-volume manufacturers and the important role these studies play.
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May 3, 2024 | 
cellandgene.com | Zeb Khan |Takehiro Okumura |Erich Bozenhardt |Rajendran Arunagiri
Hello Cell & Gene readers,I'm happy to bring you April's most-clicked articles. Enjoy!Erin Harris, editor in chief Follow me on XAPRIL'S BEST FEATURED EDITORIALWhen Does GMP Matter In Non-GMP Settings? Would you ever need to follow GMP standards in workspaces where GMP is not required or possible? This article digs into why, when, and how to follow the principles of GMP.
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Apr 25, 2024 | 
biosimilardevelopment.com | K. Coleman |Erich Bozenhardt |Victoria Meyer |P. Bhendale
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Newsletter
| April 25, 2024
Webinar: Key Elements of Process and Analytical Development to Support Biologics Tech TransferJoin us on May 13th as our expert panel discusses the intricacies of technology transfer, drawing from real-life case studies. Investigate critical components for success, risk assessment, and effective mitigation strategies.
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Apr 15, 2024 | 
cellandgene.com | Erich Bozenhardt |Kaitlyn R Rouillard |Rachel Ward
Introducing the inaugural Cell & Gene Therapy Pricing & Reimbursement Summit. Biotech, pharma, physicians, healthcare providers, and regulatory and government agencies will unite to address key issues such as the impact of regulatory acts, implementing pricing models, and collaborating on enhanced reimbursement strategies, aiming to expedite the availability of these advanced therapies to patients.
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Apr 8, 2024 | 
outsourcedpharma.com | Erich Bozenhardt |Doug Dayhoff |Incog BioPharma |Louis Garguilo
Don't get trapped in the misconception that only biomanufacturing process systems need maintenance. Here are some real-life examples of facility maintenance programs gone wrong. Inclusion Bodies: Mother Nature's Help Or Hindrance? The pros and cons of soluble and insoluble processes: isolating, solubilizing and properly refolding, and strategies to improve the performance of IB processes.
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Apr 1, 2024 | 
bioprocessonline.com | Erich Bozenhardt
Guest Column
| April 1, 2024
By Herman & Erich Bozenhardt
In the first two parts of this series, we covered production operations and maintenance of biopharma facilities, and we exposed the most common flaws in a plant.
Now, what if a plant was saddled with a bad design driven out of inexperience or cost control? In this situation, the plant must adapt as best as it can, given the process or facility it was handed.
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Mar 28, 2024 | 
biosimilardevelopment.com | Erich Bozenhardt |April Wang |Diane McCarthy |Li Jing
Don't get trapped in the misconception that only biomanufacturing process systems need maintenance. Here are some real-life examples of facility maintenance programs gone wrong. Pharma companies doing business in China have four key routes to register drugs faster than the standard ways. This discussion breaks down accelerated pathways and offers tips on how to approach them. When characterizing PQAs, the multi-attribute method offers a one-stop shop for analysis.
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Mar 22, 2024 | 
pharmaceuticalonline.com | Erich Bozenhardt |Brandon Cole |Christina Adkison |Jagjyot Kaur
Don't get trapped in the misconception that only biomanufacturing process systems need maintenance. Here are some real-life examples of facility maintenance programs gone wrong. 5 Ways Pharmaceutical Manufacturers Can Improve Productivity And QualityWith expectations that drugs will be produced faster and more inexpensively, how can a pharmaceutical manufacturer be prepared for what’s on the horizon?
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Mar 14, 2024 | 
biosimilardevelopment.com | Erich Bozenhardt |Kamil Shaik |Guriqbal Singh
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Newsletter
| March 14, 2024
After decades of helping to rescue biotech and pharma companies from environmental monitoring excursions, Herman and Erich Bozenhardt bring this discussion about specific problems you should avoid. A key challenge to better uptake of continuous processes in biologics manufacturing is the necessity to link unit operations.
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Mar 11, 2024 | 
outsourcedpharma.com | Mark Witcher |Erich Bozenhardt |Desline Barber |IDT Biologika |Louis Garguilo
Webinar: How To Identify And Quantify Adeno-Associated Virus Fill States Using Analytical UltracentrifugationIn addition to discussing how to implement Maruno's method of analysis to identify various fill states in AAV preparation, we’ll also cover the utilization and technical limitations of other techniques, such as analytical CsCl density gradient analysis and SEC-MALS, for characterization of AAV samples. Click here to learn more.
