Large Volume Parenteral (LVP) dosage forms, including saline solutions, nutrition solutions, emulsions, blood products and derivatives, contrast agents, antibiotics, oncological drug products, etc., are a clinically important class of parenteral pharmaceutical therapeutics. While LVP dosage forms have been clinically and commercially relevant for decades, the evolving regulatory landscape has substantially increased the level of rigor and detail with which LVPs dosage forms and their associated packaging systems are qualified as being suited for their intended use, including patient safety.
This high level of regulatory scrutiny that has been put on LVP-system qualifications originates from the observation that the daily volume of the administered solutions or drug products for LVP-applications is very high (often a few liters per day). As a consequence, the “dose based” safety assessments for leachables for the contained solutions or drug products are very challenging, as these leachables need to be detected, identified, quantified and assessed for their safety at extremely low concentrations in often very complex matrices.
These challenges have created a situation where qualification often requires more extensive participation on the part of all suppliers at all levels of the supply chain for LVP packaging systems.
This 2-days event brings together all relevant parties to discuss the challenges involved from different perspectives. Day 1 features prominent speakers from companies directly involved in the value chain: from raw materials to finalized products. The following day features a deep dive on the technical aspects of a safety qualification of a LVP.
Topics that will be addressed include:
- Qualification of raw materials
- Qualification of components of a LVP-system (films, tubings, ports, administration sets,…)
- How to design an LVP-system for a specific drug product application
- Blow-Fill-Seal as an alternative technology in the production of LVP systems
- Qualification of a complete LVP-system
- The need for secondary packaging for an LVP-system and how to qualify
- Printing on an LVP-system and the risk for ink migration
- Regulatory requirements (US, EU) and expectations in the LVP qualification process
- LVP-system: a Pharmaceutical Container, Medical Device or Combination Product?
- Sharing regulatory feed-back from submissions of LVP applications
- Specific Challenges in the design and execution of an extractable study for LVP systems
- Specific Challenges in the design and execution of a leachable study for LVP systems
- The potential value of simulation studies for LVP applications
- Dealing with “Unknown” leachable compounds: the necessity to go the “extra mile” in the analytical program of a leachable study.
- Specific Challenges in the toxicological assessment of extractable and leachable results for LVP systems