ATMP therapy: a collaboration between a biotechnological company and a hospital

Advanced therapeutic medicinal Products (ATMPs) are medicinal products for advanced therapy, such as cell therapy and gene therapy. ATMP therapy is a collaboration between a biotechnological company and a hospital. Treatment consists of administering (genetically) manipulated cells that initiate a specific process in the patient’s body. Treatments often brings high costs, severely ill patients and limited amount of product and time.

For a biotechnological company, it is crucial to assure   a continuous supply of the product to the patients.  For ATMP therapy products, the hospital has an important role in the supply chain and  process. Therefore, an excellent and constructive collaboration between the biotechnological company and hospital is required.

A fruitful collaboration consists of a mutual agreement of expectations. This alignment of expectations can only be achieved by understanding the importance of requirements in order to provide the best product and treatment to the patient. A gap analysis based on performed hospital audit(s), related guidelines, regulatory expectations and product requirements can be used to define what is required to qualify  the hospital to treat patients with the ATMP product.

An effective collaboration between the pharmaceutical company and the hospital can be achieved by:

  • A single point of contact in each organization to discuss quality-related questions
  • Clear requirements from regulatory as well as product perspective
  • A good understanding of the background and interests of both parties
  • Providing sufficient assistance in improving the hospitals systems and documentation
  • Clearly and properly defining the requirements and agreements in a quality agreement
  • Audit (s) and training (e.g. on reconstitution, or provision of patient derived cells or tissues) which are key for regulatory compliance and delivery of the best product quality to the patient

Regulatory authorities are still exploring the field of ATMP and expectations are changing. Differences in expectations from local authorities are not uncommon, however, can impact the operation of hospitals. Also the observations made from working together with mutual hospitals (in multiple regions) can result in new insights. A good continuation of the collaboration, with insights in probable occurring or expected gaps, can introduce and improve the accurate provision of safe and effective medicinal products to patients.

Progress can help you in build a constructive partnership with the hospital

  • We are experienced in dealing with the hospital culture
  • We have excellent knowledge of the ATMP requirements for hospital, couriers and intermediate manufacturing locations as well as manufacturing companies
  • We are excellent in training and auditing
  • We can help you setting up and completing quality agreements
  • We can implement and/or improve ATMP-related processes within your organization

 

Kathinka van Hooren

Kathinka van Hooren

Consultant
k.van.hooren@progress-pme.nl