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Rapid Mycoplasma testing in autologous cell therapy: advantages, limitations, support, and obstacles

Rapid detection of Mycoplasma is essential for autologous cell therapy products with short shelf lives. Developing, validating, and transferring a rapid Mycoplasma test based on real-time PCR technology presents many unique challenges. Application of a risk-based approach during development mitigates most issues prior to validation. Proactively removing these obstacles facilitates a successful implementation supported by regulators for implementation as a routine lot-release test.

  • Define challenges associated with testing autologous cell therapy products
  • Mitigate risks unique to testing for Mycoplasma
  • Identify method selection criteria to facilitate successful validation
  • Describe advantages and limitations of an implemented rapid Mycoplasma test

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John Duguid, Principal Process/Analytical Scientist, Aastrom Biosciences

John Duguid is a Principal Process/Analytical Scientist at Aastrom Biosciences in Cambridge, MA. Aastrom Biosciences acquired Genzyme’s Cell Therapy and Regenerative Medicine (CTRM) business in 2014. Mr. Duguid is currently responsible for developing, validating, and transferring molecular biology assays for rapid microbiology and cell differentiation applications, managing complex projects to implement process changes, and using statistical process control tools to implement process analytical technology for cell therapy products. He has been with CTRM since 1995.

ProteinSEQ™ Protein Quantitation System: bringing the sensitivity of qPCR to protein quantitation

The removal of host cell impurities is a critical step in the production of biopharmaceuticals. Traditional methods of quantifying residual host cell DNA, Protein A, and host cell protein impurities have been limited by narrow dynamic range, lack of sensitivity and specificity, and slow time-to-results. Life Technologies has responded to these challenges with a revolutionary new solution. The ProteinSEQ™ Protein Quantitation System is a breakthrough immunoPCR technology for sensitive and reproducible quantitation of Protein A or host cell impurities.


In this session, learn about the key features and benefits including:

  • Automated analyte extraction for most efficient workflow, higher run-to-run reproducibility, and minimized assay failure rate
  • Broad dynamic range of 4 logs
  • High sensitivity with an LOQ of 0.1 microliters

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Wesley Straub, PhD, Senior Pharma Analytics Product Manager, Thermo Fisher Scientific

Wesley Straub is a Senior Pharma Analytics Product Manager at Thermo Fisher Scientific and is responsible for development of new platforms for protein analytics. Wesley has more than 15 years of protein chemistry and characterization experience. Prior to joining Life Technologies, now part of Thermo Fisher Scientific, Wesley managed software and consumables for the label-free protein platform at ForteBio until its acquisition by Pall Corporation. He also led downstream development efforts for the purification and characterization of novel IgG and non–antibody-based biotherapeutics and biosimilars. Wesley received a Bachelor’s of Science in Chemistry from Boston University and a PhD in Pharmaceutical Chemistry from UCSF. As a post-doctoral scholar at the University of Frankfurt, Wesley developed novel forms of biosynthetic protein labeling, and described new paradigms for the structure-function relationship of stem cell transcription factors.

MicroSEQ® ID Microbial Identification System: method for genotypic microbial ID

Highly accurate identification of bacterial and fungal contaminants typically in less than 5 hours.

  • Learn how the next-generation, high-throughput MicroSEQ® system delivers right-first-time accuracy

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Priya Balachandran, PhD, Pharma Analytics Product Manager, Thermo Fisher Scientific

Priya Balachandran is the Product Manager in the Pharma Analytics business group. Priya has extensive experience in the area of microbiology and molecular biology. She has a PhD in microbiology from University of Alabama at Birmingham followed by a post-doctoral fellowship at University of California at San Francisco. She joined Life Technologies, now part of Thermo Fisher Scientific, in 2007 as an R&D scientist in the applied markets group, where she led multiple assay and sample prep product development projects for validated food safety testing and pharmaceutical markets. She began her product management role in late 2011, and manages the residual DNA testing portfolio as well as the microbiology portfolio, which includes the MicroSEQ® ID system and the ViralSEQ™ assays for the Pharma Analytics business unit within BioProduction.

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