Decentralization, AI, and Gene Editing Are Opportunities for CGT Contractors

Decentralization, artificial intelligence (AI) process modeling, and advances in gene editing are expanding the cell and gene therapy (CGT) production toolkit and creating opportunities for third-party contractors.

The CGT industry makes extensive use of CDMOs, with—depending on who you ask—anywhere between 66% and 90% of CGT production being outsourced to an external manufacturer.

Contractors play a pivotal role, in part, because they have the real-world production expertise that therapy developers lack, says Alan Smith, PhD, global head of innovation at recently founded CDMO, Rose Biosolutions.

“Highly experienced CDMOs offer broad experience and capability, along with mastery of the activities required for a successful manufacturing, quality, and regulatory strategy needed to realize the partner developer’s vision.

“Good CDMOs build relationships; great CDMOs build relationships on trust, defined by competency and intimacy with their partners. The relationship has evolved with the needs of partner developers and grown to include expertise, experience, and trust,” he tells GEN.

Quality control expertise is a major outsourcing driver, according to Smith, who adds, “Strong quality systems employed by CDMO partners limit risk to product quality attributes that are of key concern in the logistics chain.

“A thorough understanding of key product quality attributes and appropriate product characterization lead to development of control strategies that ensure product consistency and meet the requirements of logistics chain,” he says.

Decentralization

In recent years, decentralized CGT manufacturing models, where patient-specific therapies are produced local to the intended recipients, have emerged as a way of minimizing transportation requirements.

And this is creating opportunities, says Jeff Mocny, PhD, vice president of scientific leadership at Rose, who tells GEN, “CDMOs can be uniquely positioned to accommodate the manufacturing needs of decentralized paradigms. Drawing on the expertise in product manufacture, required quality elements and expedited release strategies, they can enable high-quality, safe and effective delivery preparations to enable bedside production.”

Early adoption

According to analysis, the CDMO space is competitive with most contractors seeking to differentiate themselves based on price and capabilities.

As a result, contractors tend to be well informed about potential market-reshaping advances in technology, Mocny says, citing systems that have recently emerged in the CGT space by way of example.

“There are many new gene editing strategies and gene delivery strategies which are likely to have a significant impact on the CGT space. Additionally, in vivo gene editing and gene delivery are showing promise in early studies and will likely have an impact on the direction that the industry is going.”

The post Decentralization, AI, and Gene Editing Are Opportunities for CGT Contractors appeared first on GEN - Genetic Engineering and Biotechnology News.