Unlock the full Operational Value Chain

Cell and gene therapies are a rapidly evolving field of medicine that involve the use of living cells or genetic material to treat or cure diseases. These therapies hold great potential for treating a wide range of conditions, from genetic disorders to cancer. 

ATMP Operations – refers to the complex process of developing, manufacturing, and distributing advanced therapeutic products that use living cells or genetic material to treat diseases. Unlike traditional pharmaceutical products, cell and gene therapies are highly personalized and require specialized manufacturing techniques, making their supply chain and other operational areas complex and challenging to manage. 

The cell and gene therapy wider operational Value Chain, from early development to wider access and commercialisation consists of several stages and involves many business areas:
 

Research and Development

This stage involves the discovery and development of new cell and gene therapies. Researchers use advanced technologies to identify suitable target cells and genes, develop delivery systems, and conduct preclinical and clinical trials.

GMP Manufacturing

Once a therapy has been developed and proven safe and effective, the GMP manufacturing process begins. This involves the production of therapeutic cells or viral vectors in a controlled environment that meets strict regulatory requirements and involves the production of the therapy in large quantities, using specialized equipment and processes. 

Quality Control

Throughout the manufacturing process, quality control measures are implemented to ensure the safety, purity, and potency of the final product. This includes testing for contaminants and monitoring the genetic stability of the cells.

CMC Regulatory Operations

Once the manufacturing and quality control processes have been established, regulatory submissions are made to obtain approval from regulatory agencies for clinical trials and marketing authorization. CMC (Chemical, Manufacturing and Controls) regulatory operations are responsible for compiling and submitting CMC-related sections of the regulatory submissions, which include information on the manufacturing process, analytical methods, and quality control.

Commercial Operations

Commercial Operations involves the planning and execution of strategies for market access and commercialisation of advanced therapies and drug products, including building key relationships with stakeholders in the various healthcare and insurance ecosystems.

Logistics and Distribution

Once the therapy is manufactured and tested, it must be transported to treatment centres and hospitals for administration. This requires careful logistics planning, specialized transportation, and cold chain management to maintain the integrity of the product.

Patient Journey

Finally, the therapy is administered to the patient under the supervision of trained medical professionals at specialised qualified treatment centres. Follow-up monitoring and treatment may also be necessary to assess the therapy's effectiveness and safety.

As shown in the above summary of all key business areas involved, it’s clear that advanced therapies and medicinal products operational cycles require close collaboration between researchers, manufacturers, regulators, logistics providers, and healthcare providers to ensure safe and timely delivery of these advanced therapies to patients in need. radix.partners can help you orchestrate this and unlock the full operational Value Chain.