The rapid advance of so many gene therapy candidates is creating several key challenges. There is a strong need for higher viral vector yields and scalable manufacturing to reduce costs of gene therapy for affordable patient treatment, all of that while meeting cGMP compliance to ensure patient safety which, push comes to shoves, always comes first. A critical step for viral vector manufacturing is sourcing of raw materials to maximize production yield while meeting quality requirement. A change of starting or raw material later on can be hazardous and delay both manufacturing and regulatory processes. So what should you consider when sourcing raw materials that are critical? What are the critical attributes that you must look for when choosing a raw material? We know that it is not always clear or easy to understand supplier’s approach to supporting CGT, and we’ve decided to take you on blog journey to share our expertise in laymen terms on what you should expect from raw material suppliers to better support the development of your therapy and its commercialization.
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