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Learning labs

Full agenda
In person - Day 1

24th Jan 10:10 - 10:40 (CET)

A Risk-Based Approach Towards the Assessment of Process-Equipment Related Leachables - Case Study

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.

Kathleen Lava
Nelson Labs NV

24th Jan 10:50 - 11:20 (CET)

Advanced Parenteral Closure Solutions, The Perfect Fit Towards Compliance With EMA GMP Annex 1 Revision

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.
Estelle Verger
Aptar Pharma

24th Jan 11:30 - 12:00 (CET)

The Journey of a CDMO Choosing EZ-fill® Pre-Sterilized Vials and Syringes. A Story of a Perfect Match for Quality, Flexibility & ROI

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).

Fabio Bertacchini
Stevanato Group
Eugenio Starita
Pharma Industry Expert

24th Jan 12:10 - 12:40 (CET)

EVERIC® freeze - A Glass Vial Optimized for Deep Cold Storage

After years of investment in research & development, pharmaceutical companies have brought to the market a growing number of new therapies based on mRNA or viral vector technology, which require storage at freezing temperatures.

Deep cold storage poses great challenges to the primary packaging container. This session will be dedicated to exploring the challenges and latest developments in ensuring the integrity and stability of pharmaceutical drugs stored at deep cold temperatures. The attendees will have the chance to learn about the benefits of the latest SCHOTT Pharma innovation: EVERIC® freeze, a glass vial, with optimized strength for deep cold applications down to -80°C.


24th Jan 12:50 - 13:20 (CET)

Pitfalls in Combination Product Verification Testing

Design Verification (DV) testing is the critical point in a Combination Product development program when all activities converge to generate the performance data necessary to support a successful regulatory filing.

Any failure or delay during the DV stage of program has the potential to directly impact submission filing dates and initiation of clinical trials or commercial launch. Based on EdgeOne Medical’s extensive experience with design verification testing, this technical talk will highlight some key pitfalls that we’ve had to help our clients navigate to achieve success with their testing programs: test method validations; sample sizes and setting design input requirements.


24th Jan 13:50 - 14:20 (CET)

Advancements in Targeted Drug Delivery for Nasal and Pulmonary Devices

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.


24th Jan 14:30 - 15:00 (CET)

Key Considerations for Your Combination Product Strategy

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

Gurmeet Singh
West Pharmaceutical Services

24th Jan 15:10 - 15:40 (CET)

Oxygen Permeability Considerations and Performance for Prefillable Syringes

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.


24th Jan 15:50 - 16:20 (CET)

Gerresheimer's Product Platforms: Designated Quality Levels to Secure Best in Class Performance in Multiple Application Fields & Demanding Disease Areas

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.

Stefan Verheyden
Gerresheimer AG
In person - Day 2

25th Jan 10:10 - 10:40 (CET)

Prefilled Ophthalmic Syringes - New Possibilities in Terminal Sterilization

Eric Offermann and Bernd Zeiss will speak about Nitrogen Dioxide (NO2) as a new sterilization method and an alternative to EtO gas. A joint study carried out by Gerresheimer, Sterigenics and Früh, showed that NO2 is well suited to terminally sterilize prefilled ophthalmic syringes. The following 5 topics will be addressed in detail

  • Comparison of EtO vs. NO2 penetration into the filled syringe. 
  • Analyze gas ingress through 4 different plunger stoppers including silicone oil-free and standard rubber plungers. 
  • Scrutinize gas ingress through 2 different cap designs based on different elastomer properties. 
  • Investigate gas permeation through COP plastic barrels compared to glass. 
  • Check if the final blister has an influence on either sterilization method. The ultimate objective of this study was to offer the best syringe design and packaging paired with the most suitable sterilization modality to pharma customers.

25th Jan 10:50 - 11:20 (CET)

How Primary Packaging can Accelerate Today's Drug Development & Approval Process

Bormioli Pharma has developed a solid and extensive patient-centric innovation program intended to advise the pharma industry along the entire drug development process, from early stage compatibility assessment up to the production of parts needed for drug fileing, clinical trials and commercialization. 


In the current healthcare domain where personalized medicine, biosimilars, gene-cell therapies, orphan drugs new formulation are becoming increasingly important, the choice and the development of the most appropriate pharmaceutical primary packaging is fundamental for success. 


Blending patient knowledge, an innovator DNA and leveraging at the same time on a robust industrial footprint is a distinctive capability and can be instrumental for building valuable co-partnership with the pharmaceutical industry. 


Bormioli Pharma will share details on its “Invents Department” and how biopharma companies leveraged on our services to accelerate the adoption of their biotechnology-based therapies.

Federico Piutti
Bormioli Pharma

25th Jan 11:30 - 12:00 (CET)

Sustainable Drug Delivery: The Device Supplier's Perspective

This session will explore:

  • The role of the device supplier in overall product sustainability
  • Benefits of lifecycle assessment (LCA) in device development
  • Trade-offs between usability, cost of goods, and carbon footprint
  • Challenging Pharma to close the circle and enable better solutions
Chris Muenzer
Haselmeier, a medmix Brand

25th Jan 12:10 - 12:40 (CET)

Challenges of Extractables & Leachables Experience

The investigation of the chemical compatibility between a drug product and its container relates to drug product quality, efficacy and safety-critical parameters for the development and commercialization of a drug product. This implies assessing the extractables and leachables for each new drug product before submission for marketing authorization, and to re-evaluate requirements for each variation of an existing drug product. A 'Toxicological Risk Assessment' must also be conducted to evaluate patient exposure to chemicals over shelf-life and it is the responsibility of a Pharmaceutical company to provide timely evidence on the quality of their finished product. Tools & methodology for E&L studies can be deployed to anticipate challenges and provide key data to de-risk your drug combination product development, even at an early stage.

Cécile Perret

25th Jan 12:50 - 13:20 (CET)

Different Coated Rubber Solutions for Safe Storage of Innovative Drugs

Learn about the different coating technologies for rubber stoppers, their unique features, and their applications in the pharmaceutical industry. Additionally, discover UltraShield™, Datwyler's latest development that meets the highest demands for drug compatibility and cold storage.

Camille Ermine

25th Jan 13:50 - 14:20 (CET)

Pre-filled Syringe & Packaging Considerations for VHP (VH2O2) Sterilization Applications

Vaporized Hydrogen Peroxide (VHP or VH2O2) is a growing option for sterilizing pre-filled syringes that contain an aseptically filled biological product. 


The sterilization of the syringe exterior surfaces, packaging, and associated components allows for a sterile presentation to the patient reducing the risk of infection. The recently published ISO 22441 standard defines the development, validation, and controls for VHP sterilization, however, there are several steps to consider as part of the feasibility process for pre-filled syringe products. 


This presentation will focus on the key areas to consider for pre-filled syringe designs used in a VHP sterilization process. Items discussed will include best design practices for vacuum tolerance, materials, and flow path considerations.

Juha Mattila
STERIS Life Sciences

25th Jan 14:30 - 15:00 (CET)

Product and Package Validation Testing

The validation of healthcare products and sterile barrier packaging prior to placing them on the market is of the upmost importance to the safety of end users and patients. This presentation will give an overview of supporting testing and provide guidance on conducting successful studies.


25th Jan 15:10 - 15:40 (CET)

Our Radiation Technology Centers: The Importance of Properly Defining Sterilization and Max Dose

Proper definition of sterilization and max dose values is critical to the creation of a robust radiation sterilization process as part of your product’s route to market. Radiation Technology Center Senior Manager Pierre Reppert shares best practice for processing samples to define these values for gamma, e-beam and X-ray radiation processing.


25th Jan 15:50 - 16:20 (CET)

Navigating the Impact of New PFAS Regulations on Pharmaceutical Packaging: US vs EU Perspectives

Per- and polyfluoroalkyl substances (PFAS) have long been integral in pharmaceutical packaging due to their unique properties. However, emerging regulatory changes in both the United States and the European Union have signaled a pivotal shift in the use of PFAS materials, particularly in pharmaceutical packaging.

This 35-minute speech will delve into the implications these new regulations pose for the pharmaceutical industry and explore the differences in approaches between US and EU authorities.

The discussion will commence with an overview of PFAS materials and their historical significance in pharmaceutical packaging, elucidating the reasons behind their prevalent use. Emphasis will be placed on the unique characteristics of PFAS, ensuring the safety and efficacy of pharmaceutical products. Subsequently, the speech will scrutinize the recent regulatory landscape in both the US and the EU. The contrasting approaches adopted by the respective authorities regarding PFAS regulation will be highlighted, encompassing the restrictions, bans, permissible limits, and timeline for implementation. This comparative analysis aims to elucidate the divergent strategies and their potential impact on the pharmaceutical packaging industry in each region. Furthermore, the speech will explore the challenges and opportunities arising from these regulatory changes.

It will address the implications for pharmaceutical companies, including the necessity for alternative packaging materials, compliance strategies, potential economic ramifications, and the quest for sustainable alternatives that maintain product safety and efficacy. Moreover, the audience will gain insights into the technological advancements and innovative solutions emerging in response to these regulations.

The discussion will touch upon ongoing research and development efforts aimed at creating PFAS-free packaging options without compromising pharmaceutical product integrity. In conclusion, the speech will underscore the importance of proactive adaptation and collaboration between stakeholders in the pharmaceutical industry to navigate the changing regulatory landscape. It will advocate for a concerted effort to foster sustainable practices and drive innovation in packaging materials while ensuring the highest standards of product safety and compliance with evolving regulations in both the US and the EU.

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