Newsletter | October 14, 2020

10.14.20 -- Genetically Engineering An IL-15 Superagonist

 
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Expediting Viral-Based Vaccines Development, Part 1

This presentation describes how vaccine developers can accelerate their timelines and develop highly efficient vaccine processes using multiparallel bioreactor testing tools, DoE software, and single-use solutions.

How To Pick The Right CDMO For Late-Phase Clinical Trials

This article examines some of the key criteria for selecting the right CDMO partner and includes a case study that shares some of the challenges involved in a late-phase technology transfer for a parenteral product.

A Modern Take On Cell Therapy Logistics

Here are my highlights on an International Society of Cellular Therapy (ISCT) 2020 session that introduced a new way to ship and transport cellular materials that puts patients front and center.

Quality Assurance And Your CDMO

The result of regulatory compliance with quality standards is binary, but the processes employed to get there don't need to be rigid, inefficient, and expensive. Learn how innovation drives efficiencies.

Security Of Supply In Cell And Gene Therapy Manufacturing

With so many challenges in cell and gene therapy manufacturing, building an adequate supply chain with the necessary equipment and protocols is critical for companies pursuing these life-saving drugs.

Streamlining Buffer Management To Enable Facility Flexibility

Improving efficiency in buffer delivery is an important part of meeting the goals of Biophorum’s road map for the future, which could be a critical strategy in increasing productivity and decreasing costs.

Important Parameters For Packing Nuvia HR-S Resin At Process Scale

Process-scale production typically involves more than one column. The packing quality of each column affects the efficiency of the whole workflow and is an important validation criterion.

Galactosylation: Influence On Fc-Mediated Binding, Properties Of Adalimumab

Comprehensive characterization of new therapeutic monoclonal antibodies requires a deep understanding of their structural and functional critical quality attributes, which greatly impact potency, stability, and safety.

Selecting A CMO: Top Considerations

Choosing the right contract organization to handle the development and manufacturing of a drug product is of critical importance. Here are tips to ensure a successful outcome.

Is Your Complex Formulation Process Set Up For Success?

Any company pursuing a drug delivery system that involves a complex formulation must be prepared for the requirements this type of drug development entails to achieve successful scale-up.

An Optimized Protein A Resin To Minimize Elution Buffer Selection Impact

In this application note, the impact of the elution buffer counter-ion, pH, and molarity were evaluated on the key purification performance parameters of Amsphere A3. In total, five different monoclonal antibodies (mAbs) were used for the study.

Perfusion: Best Practices For Evaluating A Perfusion Medium

By using a perfusion process, cell density and product titer can reach higher levels than is possible with conventional fed batch. This informative ebook will help get you started on your path to perfusion success.

Debunking Myths And Misconceptions About Softgels

Here, we take a look at some common myths about softgels and explore why drug developers may want to reconsider their go-to delivery methods.

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