Increased sterility assurance levels, increased productivity and faster access to market,  with reduced investments are becoming increasingly urgent priorities. The presentation of Mr. Kupferman will outline certain recent approaches and outlin appropriate technological solutions in these fields, taking into account risk management procedures.

The FDA Draft Guidance “Container/Closure Systems for Packaging Human Drugs and Biologics” was issued in 1999.  But in the past decades, there has been a change in the scrutiny of the way FDA reviewers looked at E&L data.   They have gradually increased the requirements, not backed up with any official document (Guidance, guideline…) which left the Pharmaceutical Industry in the dark, second guessing of what the current position and requirements were of the FDA to support a submission.

In this presentation, the key factors of success of any given E&L project will be highlighted.  Crucial is to understand what regulators really want and aligning the design space of an E&L study to their expectations.

Facing the reality of the ever-evolving regulatory landscape, analytical testing labs need to be on the forefront with expertise in the field of extractables and leachables testing and state-of –the art technology.  Meeting the development needs and requirements, of the pharmaceutical and biopharmaceutical industries, also raises the bar for material suppliers.

Only through successful partnering between drug product vendors, material suppliers and the CRO performing the test, a true mitigation of the risk related to packing can be established.

There is a trend of the pharma market to a wide variety of new drugs, small quantities and more and more high potent.

• Definition of high potent drugs
• Challenges of the drug product manufacturing of a CMO  
• Presentation of a validated solution considering the various safety influencing parameters related to:
  • Filling machine
  • Environment
  • Waste

Traditional “off-the-shelf” primary packaging solutions for parenteral use may not always meet all the different aspects associated to modern, evolved biotech and specialty applications, therefore the definition of correct design inputs is paramount in the development of a primary packaging system intended for the delivery of biotech drugs. Covering aspects like “intended use”, chemical and biochemical compatibility, performance characterization, design for manufacturability, are the cornerstone of any development path required for combination products, securing a robust regulatory compliance.

Only the companies that can offer an holistic view and a combined set of capabilities, from project management to manufacturing assets through device integration, can help to mitigate the risk associated to the development challenges. This paper will explain how SG covered these challenges in recent developments for injectable biotech products.

A growing number of biopharmaceutical drug formulations are entering the market. The drug substance of these biopharmaceutical is often a protein or peptide. Proteins are more sensitive to heat, light and chemical contaminants. Interaction with leachables from the packaging materials used for the container closure system can lead to chemical and/or conformational changes and degradation and/or aggregation, possibly rendering the protein ineffective or immunogenic.

To meet the evolving needs of the biopharmaceutical drug formulations packaging requirement, the fluoropolymer-coated rubber closure is the promising option as the sole function of the fluoropolymer coating on rubber closures is to provide an inert barrier between the rubber and the drug formulation, and to eliminate the rubber closures as a source of silicone oil based sub-visible particles .

• The market of self-injection devices and recent trends
• How to safe time-to-market when developing a custom injection device
• How to maintain the highest quality at affordable cost
• Examples of recent device projects and lessons learned

The presentation will cover the handling of the future-oriented Biotech products and the challenges for the machine supplier.

Furthermore, it will show the main characteristics of biopharmaceuticals from an supplier´s perspective.

The presentation will cover different processing solutions for biopharmaceutical products into ready to fill containers.

Moreover, a highly-flexible and fully-automatic system for processing clinical trials and minor batch sizes will be described followed by a small scale processing platform with flexible production trolleys that are operated in a standard isolator system.

Our medium speed production machines will conclude the presentation. In addition the flexible filling machines for pre-sterilized container types such as syringes, vials and pre-capped cartridges will be explained in detail with the different available options and equipment.

The implementation of single-use technologies in the final filling process is steadily increasing.

Single-use technologies can effectively meet the stringent requirements for this final process step with proper assembly design and integration.

This presentation will discuss single-use assembly design considerations and practical applications for these assemblies in the final filling process.

Particular attention will be given to the topics of flow path sterility and integrity as well as operational safety and efficiency.

Viscous and freeze-dried products are always more present in the market: advanced applications are required as they are challenging, difficult-to-inspect drugs.

Using the traditional technology to inspect them would not guarantee an adequate result, that’s why Stevanato Group has been committed in investing on research and innovation in order to offer the market advanced technological solutions. The presentation will go through the latest technology developed for the inspection of high viscosity and freeze-dried products; special inspection algorithm for freeze-dried drugs, including morphology analysis, and special light sources and application with color cameras.