Navigating ATMP fill and finish complexities

Increasing numbers of advanced therapy medicinal products (ATMPs) are entering the development pipeline.

Although these therapies, including gene therapies, viral vector vaccines and RNA-based therapeutics, provide hope for patients suffering from untreatable diseases, they also bring new development and manufacturing complexities, particularly in fill and finish.

Anticipating ATMP fill and finish obstacles

To ensure ATMP safety and quality for patients, producers must carefully navigate fill and finish process difficulties, including:

• Meeting the unique needs of each ATMP
  To maintain product stability, ATMP producers must incorporate appropriate controls, protecting these typically sensitive products from the various conditions applied throughout fill and finish, including temperature, pH and freeze-thaw cycles.

• Minimising loss
  The high cost of these innovative therapies means any material lost during the fill and finish process could cost millions. However, not all fill and finish machinery is built to minimise loss

• Selecting the right container format
  The chosen container for a biologic will depend on the dosage and the formulation. Key considerations in format selection include ensuring the formulation is compatible with the container and closure material used as well as understanding the biomolecule’s sensitivity to the proposed storage conditions.
   

Overcoming fill and finish challenges

As demand for novel therapies rises, developers are increasingly seeking support from contract development and manufacturing organisations (CDMOs) to navigate ATMP fill and finish hurdles. 

Fill in the form below and learn more about the solutions CDMOs like ReciBioPharm are applying to overcome ATMP fill and finish challenges.