Learning Labs

Location: Showfloor Theatre Booth M20 Innovations, Products & Solutions

Learning Labs

Join Us - In Paris and Online

Our Learning Labs are a collection of short presentations showcasing the latest in drug delivery and device innovation, from leading pharma companies.
The ideal platform to share your innovative product, device or solution to a captive, targeted audience.
For 2023 we have a mix of hybrid Learning Labs, hosted on the show floor and streamed for online audiences

Day 1 - Learning Labs
Location: Showfloor (Booth M20)
Time Session
10.10 - 10.40 AM
Simulating Injection Back Pressure in Design Verification Testing
Ability to achieve successful injection of drug or biologic depends on many factors including but not limited to needle diameter, drug viscosity, spring force, lubrication, plunger geometry and material properties. One additional challenge to be considered during verification of the drug delivery system is effect of back pressure from the patient (tissue). This talk will highlight various options and/or considerations for back pressure during feasibility and design verification testing. Concepts are broadly applicable to pen/auto injectors, on body delivery systems, pre-filled syringes and other delivery systems.
Scott Ariagno, Vice President, Engineering and Development Services, EdgeOne Medical
Jim Leamon, Senior Director of Client Solutions, EdgeOne Medical
10.50 - 11.20 AM
New EZ-Fill Smart™ Platform for Vials
The new EZ-Fill Smart™ Platform for Vials offers a powerful route improving pharmaceutical manufacturing quality standard while reducing the Total Cost of Ownership (TCO).
Novak Wenzel, Senior Global Director Business Development MDS, Gerresheimer
11.30 - 12.00 PM
Solving the Pre-Filled Syringes Mystery for Low Temperature Applications (-80°C)
New therapeutic treatments or prophylactic vaccines rely on more complicated drug formulations, often based on biologics. These drugs are highly sensitive and might require low temperature storage to keep them stable over shelf life. These extreme cold supply chain processes, something up to -80°C, provide a new challenge to pre-fillable syringes. In this presentation we will show you scientifically based argumentations and results to help you to select the right pre-fillable syringe for your low temperature application.
Tom van Ginneken, Head of Global Product Management Polymer Solutions, Schott Pharma AG & Co. KGaA
12.10 - 12.40 PM
Extractables & Leachables Qualification of the Primary packaging for Biological Products
In 2022, the final recommendations of the Product Quality Research Institute were published for Parenteral Drug Products. Apart from the wealth of information and considerations on design of extractable & leachable studies for parenteral drug products in general, it also contains valuable information on specific considerations for biological products. For biological products, not only the safety but also the quality of the product and related concerns about immunogenicity and leachables reactivity come into play. We will give an overview on the recommendations and how it affects the design of an extractable & leachable study for the primary packaging of biologics.
Sona Kovackova, Senior E&L expert, Nelson Labs NV
12.50 - 13.20 PM
How Market Trends Drive Innovation and Enable the Pharmaceutical Pipeline
Our healthcare industry is evolving. The move from IV to SC injection is being driven by lifecycle management, biosimilar adoption, and the hospital to home trend. Molecules are getting more complex, and patients drive the preference for self-administration resulting in the need for more complex combination product development and quick scale up. We will present innovative solutions to these challenges to help speed up drug development and enable patient choice with:
A 2.25mL polymer container system for auto-injectors which protects sensitive molecules
A large volume cartridge plunger to enable primary containment within an on-body delivery system
A small pack, high quality glass containment system to enable quick delivery in early-stage development
Nicolas Brandes, Director Product Management, Vial Containment & PFS Solutions, West Pharmaceutical Services
13.50 - 14.20 PM
Delivery of High Doses to the Lungs with Novel Orbital Dry Powder Inhaler
During this session the following topics will be tackled: the market needs for a device to deliver high drug loads to lungs; an introduction to the Orbital device – features and benefits; comparative performance of Orbital to other DPI devices; different types of molecules and formulations made using different particle engineering technologies, including spray dried and freeze dried powders and novel blending technologies; in vitro aerosol performance of drug-device combinations using clinically representative analytical methodologies (SmartTrack™); and in silico lung deposition of drug-device combinations in different disease state lung models using computational fluid dynamics and FRI™.
Gemma Budd, Director of Business Development, Aptar Pharma
14.30 - 15.00 PM
Sustainability in Mind – Aptar Pharma’s Way Forward to Circular Solutions
The pharmaceutical industry has recognized the urgency in reducing their CO2 footprint and the need to address the climate change as well as the global waste crisis through circularity. Solutions towards more circularity in the industry are therefore key and the traditional take-make-dispose linear production cycle is going to be replaced with the concept of circular economy. Aptar Pharma recognizes that drug-delivery solutions have to be part of that process and has started to develop a range of solutions that embrace the circular principles of recycle, replace, reduce and reuse. Today, Aptar Pharma is able to offer several solutions enabling pharmaceutical products with a reduced CO2 footprint for dermal, ophthalmic, nasal and pulmonary applications.
Julien Storz, Director Business Development, Aptar Pharma
15.10 - 15.40 PM
PFS and Autoinjector Drug Delivery: A Platform of Primary Packaging Solutions for Streamlined Development
Whether it is for new drug development or Vial-to-Prefilled Life Cycle Management projects, choosing the right primary packaging components is essential and will condition the success of the formulation, as well as the manufacturing and commercialization. As PFS components come in direct contact with the drug, it must remain protected throughout its life cycle, while enabling the safe & efficient delivery of the dose, even when integrated in an autoinjector.
This session will discuss the key criteria that must be considered when selecting a Pre-Filled Syringe Plunger and Rigid Needle Shield for biologics and sensitive vaccines, as well as services to derisk projects and optimized time-to-market. The performance of Aptar Pharma solutions will be demonstrated, addressing machinability, drug-container compatibility, container closure integrity under deep-cold conditions, as well as functional performance for facilitating delivery and autoinjector integration.
Audrey Chardonnet, Global Business Development Director, Aptar Pharma
15.50 - 16.20 PM
Injection Time and Usability Considerations for Self-Injection Systems, a BD Perspective
As the number of patients managing chronic diseases continues to increase, self-injection solutions play an important role in enabling the shift towards home care. Identification of potential use errors is a critical task during device development to support patient acceptance and usability. The design of these solutions can help overcome some of the usability challenges associated with self-injection, such as injection time limits and risk of premature device removal. As biologic dose volume and viscosity increases, meeting injection time requirements and usability considerations with autoinjectors can be increasingly challenging.
During this session, we will discuss device design elements that can impact the hold time of autoinjectors and the resulting usability considerations, such as the gap between second click and actual end of dose. Premature device removal is one example of usability errors that can result from the second click occurring before actual end of dose. Design alternatives to avoid risk of premature device removal during self-administration will be explored including that of the BD Physioject™ Disposable Autoinjector and the BD Libertas™ Wearable Injector.
Lionel Maritan, Associate Director Program Management, BD Medical - Pharmaceutical Systems
Day 2 - Learning Labs
Location: Showfloor (Booth M20)
Time Session
10.10 - 10.40 AM
Introduction to Human Factors Engineering
Human Factors Engineering (HFE) process participates in the product development for a safe and effective use by the end-user population. HFE data are under agencies' scrutiny as part of the design control of a drug - device combination product. Timely planning can be challenging during combination product development. This session will outline: HFE definition and overview of the regulatory landscape; presentation of formative and summative studies process; and benefits and planning of HFE activities during combination product development.
Benefit: Beyond the definition of Human Factors Engineering, understanding how studies related activities impact the final product design and how to plan for timely data generation during combination product development.
Alice Maden, Clinical & Human Factors Manager - Medical Affairs, BD Medical - Pharmaceutical Systems
10.50 - 11.20 AM
Rigid Needle Shield: The New Standard for Prefilled Syringes
Rubber compound FM30 is a well know compound offered by all big syringe manufacturers these days. It is a low extractable compound with a high gas permeability and is suitable for producing both a needle shield and a tip cap which are sterilized by ethylene oxide. There is a clear trend to move from the traditional soft needle shield towards rigid needle shield due the advantages it offers like avoiding the risk of needle stick injuries. Also with the growth of auto-injectors, rigid needle shields are preferred over soft needle shields. Datwyler's portfolio only existed out of soft needle shields still 2020 but now the rigid needle shield is available both in 1/2" and 5/8". This offers the opportunity to customers, who are already using FM30 for their needle shields, to easily transfer from a soft to a rigid design. In order to support customers with data to facilitate the choice of a needle shield, studies were conducted which show the excellent functional performance of this new product in the prefilled syringe portfolio of Datwyler. The results of these studies will be shared during this session.
Carina Van Eester, Global Platform Leader PFS and cartridges, Datwyler
11.30 - 12.00 PM
Product Packaging Design & Sterilization
Packaging is an integral part of the design for pharmaceutical products and medical devices. Not only does one need to take into account the look, feel, and protective qualities of the packaging but design must be considered when determining the sterilization technology. Determining the sterilization technology early in the design process, and concurrently working with your sterilization supplier can minimize risk and optimize outcomes. This presentation will cover packaging basics including materials, methods of sterilization (Ethylene Oxide and Radiation) and also explore packaging design challenges and solutions for Ethylene Oxide process validation
Stefan Reisbacher, Technical Advisor, Sterigenics
12.10 - 12.40 PM
Tomorrow's Sustainable Packaging: Discovering Three New Routes
Implementing sustainability in pharmaceutical packaging needs a two-way methodology: on the one hand, a scientific, data-driven approach to support today’s industrial solutions; on the other hand, a ground-breaking, never-stopping innovation research to anticipate future evolutions.
With this Learning Lab, Bormioli Pharma discloses in preview the three drivers which are defining the Group’s mid-long strategy in terms of product sustainability, opening up the debate to a qualified audience of pharmaceutical professionals. Why should you attend this Learning Lab?
To have a clear picture of all the sustainable packaging solutions now available on the market;
Grasp the occasion to be updated on the latest development directions
Clearly understanding opportunities to implement sustainable packaging in your business.
Roberto Valenti, Head of Materials Development, Bormioli Pharma
12.50 - 13.20 PM
Latest Data of OXYCAPT Multilayer Plastic Vial
OXYCAPT is a multilayer plastic vial that consists of three layers, COP/New Polyester/COP. The product has achieved excellent oxygen & ultraviolet (UV) light barrier, very low extractables, high pH stability, low protein adsorption, high transparency, high break resistance, lightweight, etc. For example, the oxygen barrier is about 20 times better than the COP monolayer vial and the UV barrier is much better than the transparent type-1 glass and COP monolayer vials. We will show a lot of new useful data such as ultra-low temperature resistance, quick defrosting test, photo-stability test on antibody drugs, etc. We believe that OXYCAPT can offer a multitude of benefits to the rapidly growing field of biologics and gene/cell therapies.
Hiroki Hasegawa, Researcher, Mitsubishi Gas Chemical
13.50 - 14.20 PM
Advanced Delivery Device Technology to Simplify the Reconstitution of Lyophilized Drugs
Lyophilization (freeze drying) is a proven process for increasing the shelf life of vaccines, biologics and other injectables. But delivering these products requires several use steps that make them challenging to administer, particularly by patients and caregivers in non-clinical settings. To address these needs, Haselmeier has been developing several solutions for an easier and more convenient reconstitution and administration.
This presentation will cover different types of primary drug containers such as vials and dual chamber cartridges for reconstitution along with the available device solutions to simplify delivery. The challenges and advantages of each solution, including vial to cartridge, out-of-pen reconstitution, and in-pen reconstitution will be discussed.
Chris Muenzer, Vice President of Innovation and Development, Haselmeier GmbH
14.30 - 15.00 PM
Accelerated and Real Time Aging / Stability Studies
The presentation will look in some detail how aging / stability studies are established and address the following:
What is aging / stability?
What is purpose of aging / stability testing?
What about relative humidity?
What risks are involved?
How long is the shelf life of your product?
Noel Gibbons, Technical Advisor - Packaging, STERIS AST
15.10 - 15.40 PM
How to address sustainability in biopharmaceutical industry - sharing from Saint-Gobain Life Sciences
This session will give insights on the trends our sector is facing: decarbonization and circular economy. It will also provide an overview on the work done at industry level. And finally, you will be able to learn more on what Saint-Gobain Life Sciences is willing to offer to supply single-use technologies in a more sustainable way.
Caroline Calmels, Sustainability Market Manager, Saint-Gobain
15.50 - 16.20 PM
Sustainable Pharma Packaging
We at Körber believe the pharmaceutical industry will ultimately dispense plastic packaging within a few years. Our Rondo Solutions are pioneering when it comes to sustainability. Today pharmaceutical packaging expects to be innovative, compact, safe, and environmentally friendly. That’s because opinions in this area also began to change some time ago. The aim is to dispense with plastic and replace it with biocompatible materials such as recyclable boxes, compostable sachets, and environmentally friendly tubes. Wood, bamboo, and fungi serve as raw materials.
Körber has been a pioneer in the area of sustainable production chains for more than 40 years. We supply international pharmaceutical customers with packaging that is made solely of paper fibers that are also biodegradable. We not only think about ways in which we can manufacture packaging in as resource-conserving a manner as possible, but also how this packaging can best be disposed of or recycled. Another fact that speaks in favor of our sustainable solutions is that they can be produced by more than 90% of our packaging machines. Our commitment to environmental compatibility is also reflected in the numerous times that our innovative packaging solutions have received awards such as the Pro Carton ECMA Gold Award and the Pharmapack Award.
Volker Grouls, Key Account Manager, Körber Pharma Packaging Materials