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BIOSIMILAR WHITE PAPERS

  • Developing TIL Therapies: Sample Collection And Processing

    While it has been advanced over many years, the process of developing TIL therapies still suffers from certain challenges. This article attempts to lay bare some of these challenges and discuss how novel technological solutions can help overcome them.

  • Robust Field Guide To qPCR

    qPCR remains the gold standard for validation of microarray and next generation sequencing data and the method of choice for both clinical and basic research labs for a wide range of applications. However, there remains general concern about the production of data that truly reflects the tested experimental conditions. We have developed a comprehensive guide to performing the ultimate qPCR experiment. The following is a snapshot of the critical steps needed to achieve excellent results.

  • Counting DNA Molecule By Molecule

    Digital PCR is an established nucleic acid (NA) quantification technology, which enhances the broad use of PCR across molecular biology laboratories globally through improved precision and accuracy. Organizations that impact the quality of nucleic acid measurement and testing, adopted digital PCR early on and have since been pioneering its use for improved accuracy and precision in NA measurement. Ultimately, this will positively impact the quality of NA measurements generally and, more specifically, clinical NA testing. Molecular counting of nucleic acid molecules is the next measurement paradigm.

  • Pairing Data Connectivity, Automation Ease Tech Transfer/Scale-Up

    In biopharma, process data is used in many ways throughout process development and production phases. This article outlines how connectivity and comprehensive automation ease tech transfer and scale up.

  • Cell Therapy Scale-Up Strategies For Commercial Success

    To achieve commercial success, a developed process must be scalable and suitable for a manufacturing environment. The scaling strategy depends on the type of cell therapy. This article discusses options for cell therapy process development and validation that minimize risks through quality control (QC), optimization, scaling, closing, automation, and assay development, all in order to prepare for successful commercial production.

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BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS

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The COVID-19 pandemic has thrown the entire pharmaceutical industry, as well as patients, providers, and sites of care for a loop. Though small molecule novel treatments and generics have seen much more pronounced impacts from market shut-downs and supply-chain disruptions, the biologics and biosimilars industry has also been striving to understand how the pandemic will alter availability and usage of biologic products. This collection of articles surveys a wide array of considerations facing biopharma and biosimilar companies, including the pandemic's impact on regulatory interactions, product supply and demand, materials sourcing, and market access and uptake.

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