Biotechnology companies of all sizes face many challenges in the development of new cell and gene therapies. Now, more than ever, investors and regulatory bodies are focused on pre-clinical process development and production capabilities as distinct precursors that can help establish market success by emphasizing critical risk mitigation steps, automation, and product characterization – even in pre-clinical work.

In this webinar, Mike O’Mara and Dr. Ian Gaudet will introduce the development and manufacturing approach used by Miltenyi Biotec and describe how a CDMO partner focused in process and analytical development can enable clinical readiness. Webinar topics include:

  • Industry-leading technologies from Miltenyi Biotec along with a peek into the company’s new CliniMACS® Cell Factory located in San Jose dedicated to co-development, tailored application fitment, and scalable cell processing

  • Creating process robustness:  Equipment, material and reagent considerations, including integrated solutions and process automation and control
  • Why it’s important to consider commercial viability, as well as process and technology transfer risk, during pre-clinical development

Featured Speakers

Mike O'Mara

Vice President of Industrial Business Services
Miltenyi Biotec

With over 27 years of hands-on experience in the BioPharmaceutical Manufacturing industry, Mike O’Mara serves as the leader of industrial business services for Miltenyi Biotec in North America.  In this role, he leads the global commercialization of custom services from Miltenyi Biotec for Pharma and Biotech customers. He also manages custom process development, GMP manufacturing for pre-clinical, and GMP Lentiviral Vector and Cell Manufacturing.

Ian Gaudet, PhD

San Jose Facility Lead/Senior Director of Process Sciences
Miltenyi Biotec

As the leader of the Miltenyi Biotec cell manufacturing facility in San Jose, Dr. Gaudet focuses on the rapid translation of cell-based therapies from bench to bedside while enabling long-term commercial feasibility. He studied Bioengineering at UCSD, and received his doctorate in Biomedical Engineering jointly from Rutgers University and the University of Medicine and Dentistry of New Jersey.

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