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