White Paper

Manufacturing Challenges And Solutions In Cell And Gene Therapy Manufacturing

By Yatindra Tirunagari and Kassim Kolia


Global demand for cell and gene therapies (CGTs) is on the rise, and there is no sign that it will slow down anytime soon.1 This rapid increase in demand has created incredible opportunities for players in the CGT manufacturing space, but it has also created challenges in bioprocess development and viral vector cGMP manufacturing. These challenges have a strong impact on overall capacity, which is currently insufficient to meet demand.

Specifically, the three greatest challenges in the industry are:

  • Speed to market
  • Scalability (manufacturing ability)
  • Strategic thinking

A main point of the discussion presented in this white paper will be how these challenges — as well as the factors that influence them — are interrelated. Here is an example, demonstrating how one difficulty in CGT manufacturing can arise from another:

  • Batch failures can lead to high cost of goods sold (COGS), limiting patients’ access to treatments
  • A possible cause of batch failures can be lack of expertise and foresight
  • A lack of expertise can often be correlated to a general shortage of talent in the industry
  • There is a shortage of talent because of the rapidly emerging nature of the field and a lack of awareness among promising talent sources

Unsurprisingly, the most effective and elegant solutions to these problems — including, crucially, high COGS — are those that take all contributing factors into account at once rather than attempting to resolve each problem individually. With that in mind, this white paper will describe the three major challenges CGT manufacturers are facing today and provide experienced insights on how to overcome them.


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