Newsletter | November 22, 2023

11.22.23 -- How To Lose A Batch In 10 Days

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FEATURED EDITORIAL

How To Lose A Batch In 10 Days

Inspired by the rom com How to Lose a Guy in 10 Days, this article spotlights the critical missteps that could lead you to lose a batch during the manufacturing process. By identifying these pitfalls, the author guides you toward best practices that will save your batches and improve the quality, efficiency, and reliability of your operations.

INDUSTRY INSIGHTS

Realizing The Benefits Of CPV With Advanced Analytics

When implemented correctly using advanced analytics solutions, CPV can provide insights that help companies increase their productivity, reduce costs, and support iterative process improvements.

Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products

Drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.

Guide To Seeding, Expanding, And Harvesting Stem Cells

Investigate important considerations for working with three different stem cell types: mesenchymal stem/stromal cells, induced pluripotent stem cells, and neural stem cells.

Enabling Real-Time Process Control

Defined control strategies enable more intensified and stable cell culture processes, such as perfusion, which may lead to dramatically improved productivity.

Navigating A New Standard In Microbial Protein Expression

Recent advancements in genetic engineering, analytics, and screening reimagine E. coli as an “optimal” protein factory, not just a common one or an expression system artifact.

Strengthen Your IND Submission With Microbial Challenge Studies

Diverse APIs and increased regulatory scrutiny are among the factors contributing to increased demand — and necessity — for microbial challenge studies to support IND submissions.

Gene And Cell Therapy Analytical And Development Methods

Explore the importance of implementing development approaches early in the product life cycle and how analytical method choice impacts the production of safe and efficacious gene and cell therapies.

Accelerate Successful Transfer Of Recombinant Protein Analytical Assays

Learn how a CDMO that is experienced in producing and characterizing diverse recombinant proteins is essential when accelerating the successful transfer of recombinant protein analytical assays.

What Provided Critical Reagents To The COVID-19 Pandemic Response?

Typically, mAb manufacturing takes up to 60 days due to demand and outsourcing lags. Instead, imagine a unified platform that can deliver your mAb in 18 days.

How An Optimized Purification Platform Can Speed mAbs Clinical Production

Explore how a purification development platform, with a mixed-mode chromatography step, enabled the acceleration of a biotherapeutics company's clinical trial supply while achieving high-quality material.

Improving Biomanufacturing Resilience In An Uncertain Future

Three experts discuss the role and value of collaborations and what strategies can be used to help improve biomanufacturing resilience in an unpredictable but promising future.

Advances In Bioreactor Washing

Improve your cleaning and subsequent sterilization process for your bioreactors, ensuring a thorough cleaning, better reproducibility, and reduced labor.

The Path To Confidence At Every Point Of Connection

Practical information on key issues including extractable/leachable testing in components, freeze/thaw in single-use assemblies, efficiencies driven by SUT advances such as genderless connectors, and more.

Achieving Environmental Sustainability In Bioprocessing

Designing bioprocessing consumables has become increasingly important in the single-use space as a way to address sustainability concerns.

Preparative Anion Exchange Chromatography For DNA ON Purification

Production of pure therapeutic DNA ONs requires efficient, scalable, and cost-effective chromatographic purification methods. This study explores a chromatography resin pairing to determine its effectiveness.

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SOLUTIONS

Four Integrated Technologies For Protein Stability Characterization

Outsourcing Manufacturing Of Acetic Acid And Benzyl Alcohol Solutions

Waters Liquid Chromatography And LC-MS Solutions

Oligonucleotide Synthesizer

Delivering LVV Material In An Accelerated Timeline

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Join The Advancing RNA Community

Introducing Advancing RNA, an online community designed to be a forum and resource for professionals working on RNA-based therapeutics to better understand the challenges that confront them in areas such as analytical/quality, manufacturing, formulation, outsourcing, clinical research, and supply chain/logistics. Sign up for the Advancing RNA newsletter, delivered to your inbox weekly.

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