Overcoming Manufacturing Hurdles in Cell and Gene Therapy: Embracing the ‘Buy’ Paradigm
The complexity of cell and gene therapy production, along with the need for specialized expertise and substantial investment, has prompted a paradigm shift from in-house manufacturing (“Make”) to partnering with Contract Development and Manufacturing Organizations (CDMOs) (“Buy”).
The Paradigm Shift: ‘Make’ to ‘Buy’ for CGT Manufacturing
Manufacturing CGTs in-house demands extensive resources, expertise, and infrastructure. As therapies move through clinical trials and toward commercialization, the need for larger production capacity and specialized facilities becomes paramount. Recognizing the complexities and costs associated with maintaining such operations in-house, many innovator companies are now opting for the ‘Buy’ approach – collaborating with established CDMOs to handle manufacturing.
Strategies for Increasing Throughput and Efficiency
The evolution of automation and closed systems has revolutionized cell and gene therapy manufacturing. By minimizing manual processing and maintaining a controlled environment, these technologies enhance the efficiency and reproducibility of processes. CDMOs often incorporate these innovations into their suites, effectively increasing throughput and reducing the risk of contamination.
Leveraging Digitization for Process Monitoring and Optimization
The digital revolution has not bypassed the world of cell and gene therapy manufacturing. Digitization allows for real-time monitoring of processes, predictive analytics, and data-driven decision-making. This technology enables CDMOs and innovator companies to identify deviations, optimize processes, and ensure product quality, ultimately expediting the path to regulatory approval.
Supply Chain Optimization: Reducing Costs and Improving Efficiency
The supply chain for cell and gene therapy manufacturing is intricate, involving the sourcing of raw materials, production logistics, and distribution. Optimization of this supply chain is crucial to minimize costs and ensure a seamless flow of materials, reducing the risk of delays. CDMOs often have established supply chain networks, streamlining this aspect of production.
Choosing the Right CDMO Partner
Selecting the appropriate CDMO partner is a decision of paramount importance. Factors to consider include the CDMO’s track record, expertise, capacity, regulatory compliance, and ability to align with your company’s vision and goals. An ideal partner should offer a seamless technology transfer, collaborate on process development, and provide transparency throughout the manufacturing process.
As the demand for transformative cell and gene therapies grows, so does the recognition of the challenges in manufacturing these therapies at scale. The ‘Buy’ paradigm shift reflects the industry’s understanding that collaborating with specialized CDMOs can help overcome these hurdles and ensure timely access to therapies for patients in need. By embracing innovation in automation, digitization, and supply chain optimization, the cell and gene therapy field is paving the way for a future where life-changing therapies are not only developed but also delivered efficiently and reliably.
Center for Breakthrough Medicines (CBM) is a purpose-built and patient-driven, cell and gene therapy contract development and manufacturing organization (CDMO) uniquely positioned to enable pharma and biotech companies to develop, test, and manufacture life-saving therapies on a global scale. Move your program forward, consult with a CBM expert.
About The Center for Breakthrough Medicines (CBM)
Center for Breakthrough Medicines (CBM) is a purpose-built and patient-driven, cell and gene therapy contract development and manufacturing organization (CDMO) uniquely positioned to enable pharma and biotech companies to develop, test, and manufacture life-saving therapies on a global scale. Ideally located in the heart of Philadelphia’s Cellicon Valley, CBM has assembled the most accomplished cell and gene therapy experts in the world, armed with cutting-edge and innovative technologies, to offer scalable, end-to-end, best-in-class services from pre-clinical through commercial, including process development, plasmid DNA, vector manufacturing, cell banking, cell processing, and a full suite of complementary and standalone testing and analytical capabilities.