CMO, CGT manufacturing, CGT, adaptive erp, contract manufacturing erp, erp for manufacturing, cloud erp, biopharmaceutical, life sciences erp

It’s no surprise that demand continues to build and funding continues to flow in for production of cell and gene therapies (CGT). Many new CGT products are game changers — potential cures for diseases, not just treatments.

Meeting the Demand for CGT Manufacturing

With growing demand, there’s a need for more suitable CGT manufacturing facilities. But production of cell and gene therapies is complex. It’s costly. The manufacturing process is different from that of traditional small molecule medicines. With traditional biologics, approximately 35% of the manufacturing process is outsourced, but with CGTs, the industry outsources 65% or more of their manufacturing processes. Big biopharma doesn’t have the production-ready infrastructure in place. The biopharmaceutical community needs smaller, more agile CMOs now, more than ever.

Producing cell and gene therapies is a great opportunity for contract manufacturing organizations (CMOs) to grow their businesses while stepping up to support the industry. But as of July 2020, only 152 CMOs had the capability to produce cell or gene therapies for global distribution in a market that is expected to reach $13.23 billion in 2023 at a CAGR of 24.10%. 

With the great need to produce the biologic compounds that represent the future of medicine, that represent for CMOs, perhaps, the business opportunity of a lifetime, why aren’t CMO companies moving faster to fill the need?

Before they invest time and money in CGT manufacturing, CMOs need to make some foundational decisions that will affect their future efficiency, potential for growth and risk management capabilities. Those decisions can be summed up in three questions:

  • How can CMOs manage the fast growth of cell and gene therapeutics without compromising quality?
  • What Critical Quality Attributes (CQAs) should be measured and reported?
  • What manufacturing-at-scale issues need to be addressed to deliver personalized treatments directly to the patient?

The answers to these questions about barriers to entry will affect how fast CMOs step up to the new CGT manufacturing paradigms. To help, we offer a whitepaper entitled “Cell and Gene Therapy Manufacturing: A Startup Guide for CMOs” that provides guidelines for moving into CGT manufacturing with confidence. 

Building a Strong CGT Manufacturing Strategy

Building a strong infrastructure is one element of building a strong CGT manufacturing strategy. As a CMO grows and builds a manufacturing base, it’s important to implement an ERP (Enterprise Resource Planning) system. An ERP platform integrates core business processes into a single system so you operate as a connected business. An integrated core establishes a strong foundation so you can accelerate growth and minimize risk.

But with CGT manufacturing, it’s not just build it once and it’s done. The evolution of CGT manufacturing will continue. Personalized CGT products will require consistent re-engineering of process configurations. The ERP solution you choose should be flexible enough to accommodate almost unlimited changes to both your manufacturing process and supply chain and still maintain your strong integrated core.

An ERP solution well-suited to CMO manufacturing of CGTs should be in the cloud for flexibility and its vendor should be knowledgeable of regulatory and industry requirements. It’s also important to partner with an ERP supplier who understands the CGT space — who understands the needs of CMOs because they’ve worked with them for decades.

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As you prepare for CGT manufacturing, QAD offers a self-diagnostic tool to help you identify how your organization measures up in terms of a strong and flexible infrastructure. Try our Adaptive Manufacturing Enterprise Maturity Model Diagnostic.

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