Clinical trials: open issues and developments (Dr Siegfried Schmitt, Parexel)
Despite the current economic climate clinical trials are likely not only to continue at the current level, but probably also increase in numbers.
Clinical trials are cost intensive, and the drugs account for 10 - 20% of the costs. This is a significant amount and therefore operations and suppliers are under pressure to reduce cost.
There is strong growth in the area of Injectables given that most new drugs are biologics. Consequently, we see a number of innovations in delivery systems.
Regulatory guidance is focussing on sterility assurance methodologies, biological IMPs, and extractables and leachables. These are often the result of inspection findings. Finding the right balance between regulatory compliance, technical advances and cost constraints is the challenge to industry.
Development and scale-up of freeze-dried clinical products: some case studies (Laura Fontana, Patheon)
The PDS department of the Patheon Ferentino Plant is focused on sterile small volume parenteral and freeze-dried products development and manufacture. The services offered start from pre-formulation studies and analytical development up to the GMP manufacture of clinical phase I and II, including biopharmaceutical products and poorly soluble compounds.
In this job delivering the batch on time respecting the project timelines, providing a high level quality service and matching the GMP with the required flexibility is always a challenge.
Scaling up from the lab scale to the GMP manufacturing, even in the case of small batch, can hide technical/scientific issues which may jeopardize the clinical study.
Some case studies regarding what can occur during development and GMP manufacture of sterile liquid and freeze-dried clinical products are here presented under several perspectives. Synergies among the Client, CMO and Suppliers are often the key to succeed.
The pharmaceutical market is moving towards complex and specialized drugs where the aim is more effective treatments targeting specific diseases.
This new scenario requires a high degree of flexibility to shorten development cycles and time-to-market, still providing superior quality containers to safely store these high potential drugs.
The growing trend is to choose combined packaging and devices including a set of key features that simplify all the operations in order to allow the Pharmaceutical Companies to focus on drug developments.
This paper presents an integrated solution to meet the market requirements focusing on a new process and packaging concept that enlarge the range of glass containers ready to be used.
Disposable Filling Line Concepts (Klaus Ullherr, Bosch)
1. Introduction - Current Filling Systems and Machinery - Advantages of Disposables
2. Materials - Usual Materials for Pharmaceutical Filling - Suited Materials for Disposables (Special Requirements of Gamma-Sterilisation and Regulatory Requirements) - Leachables / Extractables
3. Disposable Filling Components and Systems - Components (needles, tubings, connectors, filters, bags, pumps, etc.) - Systems (peristaltic pumps, rolling-diaphragm pumps, gravimetric metering incl. outlook to time-pressure-filling and mass-flow-metering)
4. Handling - Transfer to Cleanroom or Isolators - Installation on Filling Machine
Primary packaging container and closures - Solutions from stability to full commercial production (Christa Jansen-Otten, West Pharmaceutical)
Primary drug container that have intimate drug contact are critical in the success of developing and launching new drug products.
Therefore the proper selection of the appropriate container-closure system is key for bringing a product from compatibility trials, stability studies and clinical trials through to industrialisation in a timely manner, as time to market is becoming more and more important within an increasing competitive market environment.
Beside the already demanding requirements for vials and stopper, components for cartridges and syringes must also meet both chemical and functional needs of the delivery system.
Clean modern rubber formulations as well as coated closures are available for sensitive drugs like biopharmaceuticals to minimize interaction and other effects like protein aggregation.
These closures and container/closure systems are available in various formats (i.e., RS, RU) and quality levels depending on customer requirements and preferences.
However, each drug application has unique needs that need to be addressed through the selection of the appropriate primary drug container and delivery system.