Manufacturing processes are composed of a complex set of plastic materials that may introduce process-equipment related leachables (PERLs) into the final drug product, thereby potentially compromising its biocompatibility, safety or quality. At the same time, not all manufacturing components have the same likelihood to contribute to PERLs.

A risk-based approach in which process conditions, type of process material and composition of the process solution are evaluated, allows the definition of relevant test requirements with respect to extractables and leachables.

In this presentation, you'll have the opportunity to explore the main principles of a risk-based evaluation through a case study.

The revision of the European Medical Agency annex 1 of the GMP poses new challenges for Pharma manufacturers who have to implement a contamination control and sterility assurance strategies. Aptar Pharma Injectables’ Advanced Solutions perfectly combine to support our Pharma partners in tackling these new stringent requirements: 

• PremiumFill®: Enhanced manufacturing means designed to deliver higher quality products with improved specifications, especially on contamination criteria, to boost your Contamination Control Strategy

• RTP bags: the new standard for avoiding contamination on aseptic filling lines, highly recommended in the Annex 1 revision.

• Ready-to-Use Gamma: the only 100% guarantee of sterility at the time of use as requested in the Annex 1 revision.

Stevanato Group and Mr Eugenio Starita, former CDMO Executive Director and Pharma Industry expert, share a case study about the journey of a CDMO choosing EZ-fill® solutions. 

When CDMOs need to establish the proper industrial setup and cope with the different needs of the markets to be served, there are common challenges to face.

This speech investigates how CDMOs can catch the expected business opportunities thanks to a flexible industrial setup based on pre-washed and pre-sterilized containers: opting for vials in the initial phase and for vials and syringes as capacity increases for commercial production.

The investments in RTU fill & finish lines demonstrate how CDMOs can improve productivity, final product quality and integrity, flexibility, and reduce spaces (improved ROI).

Multiple factors influence regional deposition; including patient anatomy, formulation properties, and importantly the device itself – the mechanics and design as well as the way the patient uses it. 

How much, and indeed where specifically the drug deposits in the lungs or nasal cavity can significantly impact its efficacy – whether locally or systemically acting. 

A focus will be made on new device designs that can allow pharmaceutical companies to achieve more targeted deposition, as well as in vitro measurement and in silico modelling tools to help you choose the right device for your targeted indication.

The global combination products market has seen a tremendous amount of growth driven primarily by the rise in new therapies to address chronic diseases and contributing to a robust drug pipeline driven by biologics. Additionally, the demand for self-administered therapies is pushing the need for new, intuitive, user-driven delivery devices. Novel technologies are also contributing to this growth by offering opportunities to improve drug uptake, reduce pain and improve patient compliance and experience. As pharmaceutical companies advance new therapies to market, their focus is primarily on the drug or biologic. Early selection of primary packaging components and systems to protect sensitive biologics is critical and can contribute to a long-term strategy. Consideration of the delivery device and the drug-device combination is essential for patient safety and regulatory approval. Without the proper foresight and planning, significant challenges on the device side arise, including complexities related to reliability, human factors, performance testing and process validations. These challenges are often compounded by accelerated schedules after therapeutic efficacy has been demonstrated. The evolving regulatory landscape requires pharma and biotech companies to partner with a true expert who can help them navigate the new regulations successfully.

This presentation will cover:
• Current market trends
• Understanding the Impact to Regulations -drug/drug-device
• High-value packaging
• Combination Products: Device-Development, Analytical Testing, Manufacturing

Numerous drug technologies are advancing into pre-clinical and early clinical phases to enable new therapies with improved health outcomes. Those new technologies carry potential challenges pertaining to their compatibility with the container materials and with environmental conditions such as temperature or exposure to gases. One historically common degradation pathway of pharmaceuticals is oxidation.

More and more prefillable plastic syringes are being developed as they present advantages over glass syringes on parameters such as lower inorganic extractables and a higher resistance to breakage. Plastic syringes are mostly made of COP and COC barrel materials, materials which are much more permeable to oxygen than glass. A highly oxygen-permeable container results in a faster oxygen ingress, leading to faster oxidation. For oxygen-sensitive drug formulations, this can lead to a decrease in the drug shelf life. Decreased shelf life may be mitigated by increasing the concentration of antioxidants or by adding an oxygen scavenger in the secondary packaging, which can pose other constraints. 

Therefore, there is a need to monitor and quantify the oxygen ingress within prefillable syringes to derisk pharma combination product development. 

This study, conducted on several pre-fillable syringe configurations, will highlight the influence of components on oxygen permeation and measure the syringe protection performance against oxygen ingress at different storage temperatures.

As a solution provider with a unique & dedicated product portfolio​, Gerresheimer is continuously  exploring options to better accommodate their  customers along the drug development and drug LCM journey.

With its newly installed product platforms, Gerresheimer will be combining outstanding quality levels with specific product requirements in dedicated application fields and disease areas. 

From dental care over hematology, vaccines, diabetes and metabolism disorders into complex and more demanding areas such as Cell Gene Therapy, ophthalmology and oncology ... Gerresheimer will be able to support even better in finding the best containment solution for their specific application. 

Picking one example, we'll elaborate on our offering in the ophthalmology field.