|10.10 - 10.40
Testing Requirements for Sterile Barrier Packaging and Devices
- Transportation testing accelerated ageing and package integrity testing overview
- How to construct a packaging validation protocol
- What new requirements are there for the recent releases of ASTM F1980 and ASTM D4169
- Device test considerations
Noel Gibbons, Technical Advisor-Packaging, STERIS AST
|10.50 - 11.20
End to End Sterility Assurance for Next Level Risk Mitigation in RTU Packaging
Sterile integrity is indispensable in aseptic fill-and-finish operations. Pharmaceutical companies pay highest attention to producing high quality drugs and safekeeping their efficacy during fill-and-Finish and beyond. The risks of contaminated batches leads to recalls, high costs, reputation loss and in the worst scenario may harm patients’ wellbeing. Hence, it is the pharma company’s obligation to ensure the sterility of all components when entering the aseptic filling core - which is possible, yet cumbersome with the RTU solutions that are currently available within the industry
Dr. Robert Lindner, Global Product Manager RTU Vials, SCHOTT AG
|11.30 - 12.00
Selecting Optimal Prefilled Syringe Components for COVID-19 Vaccines
The unprecedented need for COVID-19 vaccines demand accelerated drug development processes and the potential use of new vaccine platform technologies, which both pose risks to drug development.
The use of a barrier like FluroTec® film laminated onto the elastomer plunger can help to minimize vaccine product prefilled syringe storage and administration risks. FluroTec® film, which is based upon poly (ethylene tetrafluoroethylene), has chemical properties that reduce migration of leachables into the vaccine and can reduce interaction with the vaccine.
Plungers with FluroTec® film enable consistent delivery volume and break-loose and glide-force performance over a range of vaccine formulation viscosities. These plungers are globally available, approved with a variety of molecule types by multiple agencies, and are offered in 1mL long and 1-3mL sizes. This presentation will discuss how these features mitigate risks for a COVID-19 vaccine in a prefilled syringe.
Christa Jansen-Otten, Director of Technical Product Development, West Pharmaceutical Services
|12.10 - 12.40
Benefits of Nasal Drug Delivery – more than just Hay Fever
Nasal sprays have been around for decades to successfully manage conditions such as allergic rhinitis (hayfever), where treatment of the nasal cavity is the target. Locally acting nasal drug products continue to be developed to treat other infectious diseases, with a big focus on biologic molecules.
Furthermore, the COVID-19 pandemic has accelerated the interest in intranasal vaccine administration to enable rapid roll out of vaccines with fewer supply chain challenges for respiratory diseases, and these products target the NALT region of the nose.
By contrast, due to the potential for enhanced and rapid bioavailability, there is resurgence of interest in intranasal delivery to treat systemic disease, and particularly CNS indications, where direct nose-to-brain (N2B) delivery via targeting the olfactory region of the nose.
The lab will highlight the considerations for both systemic/N2B and intranasal vaccines, and the differences in approach when designing the best device and formulation combination.
Gemma Budd, Director of Business Development, Nanopharm, an Aptar Pharma company
|12.50 - 13.20
On the Road to Decarbonisation - Gerresheimer Moulded Glass
The presentation will be about the Gerresheimer – roadmap to decarbonization. The speaker will cover supplier-specific approaches like the furnace technology. Furthermore, Value-chain-comprising approaches in Ph-business (eg eco-design development) will be explained. In the end, success stories about joint value-chain comprising decarbonisation will be told.
Patrick Kraft Global, Sustainability Manager, Gerresheimer Lohr GmbH
|13.50 - 14.20
Striving for a more Circular Industry - How Aptar Pharma can Support your Sustainability Journey
The Pharmaceutical industry is increasingly facing the challenge of transforming their businesses to incorporate more sustainable practices that reduce their negative impacts on the environment. Key Pharmaceutical players are acknowledging that caring for human health is closely tied to caring for the health of the planet. However, the nature of the global Pharma business makes this a challenge to accomplish without collaboration from the full value chain.
Aptar Pharma, a key partner to the Pharmaceutical industry, is committed to furthering a more sustainable business. During his Learning Lab presentation Christophe Marie will share how Aptar is addressing the challenges of sustainability and the aspirations, goals and targets that can support a more sustainable pharmaceutical industry.
Additionally, he will outline what pioneering solutions will have the potential to evolve pharmaceutical packaging and support circular economy.
Christophe Marie, Global Product Sustainability Director, Aptar Pharma
|14.30 - 15.00
Connected Devices, Digital Health and Digital Therapeutics: Where are we heading and Why?
Our presentation will cover an introduction to Connected Devices and the different therapeutic areas that they touch.
We will also review the interaction and interoperability between the connected device and the software platform. We will discuss the need for clear definition of the intended use and how this will drive the claims which ultimately leads to the regulatory classification.
We will also review the regulatory classification, regulatory hurdles and the importance of building a road map enabling Real World Data generation. Finally, we will discuss the value and ROI for Connected devices, the most advanced countries for regulatory and reimbursement pathways.
Marcus Bates, Vice President, Digital Healthcare, Aptar Pharma
|15.10 - 15.40
Container Closure Integrity (CCI) Testing
Container closure integrity (CCI) testing is determined by evaluating whether a given container maintains its sterile barrier. It is a mandatory step in the design verification phase of a drug combination product development. Several methods exist with different advantages and limitations. This session will outline:
- Probabilistic vs deterministic CCI Testing1
- Presentation of the different deterministic CCI testing methods with applications and limitations
- What to consider when selecting CCI testing method
In this session the audience will benefit from understanding the influence of the drug specificities to select the most suitable technical option for Container Closure Integrity testing activities based on the advantages and limitations of different techniques available on the market
Robert Schultheis, Founder & Chief Technology Officer, ZebraSci
|15.50 - 16.20
On the Origin of Extractable Species
The Universe of Extractables is extremely diverse. There are many different types of materials being used in the construct of a Container system. The impurities profile of a material is typically composed of compounds that were intentionally added to a material to protect the material during production or its life cycle or to increase performance or functionality. In this case, we are talking about polymer additives. However, there is even a longer list of compounds that are present in a material that were not intentionally added. These compounds have been introduced during the production process of the material, or they are the result of ageing of the material.
The presentation will give an overview – for the most common materials used in the construct of container/closure systems or medical devices – of the main classes of compounds that are often detected in extractable studies.
Piet Christiaens, Scientific Director, Nelson Labs
Start Ups Pitch Session
This is your opportunity to discover new ideas from companies that are at an early-stage and want to know if their product may match the market's expectations.
A patented idea can become the next big thing in pharma packaging: come, listen and support them!
Gareth Pearce, Founder Director, Pacifi Ltd.
Csilla Rimóczi, Head of ECL Business Line, CODEX Ltd.
Tristan Salomon, CEO, Axom
Thomas Kern, Managing Partner Vinc ,Strategic Life Sciences Transactions
Vincent Galand, Expert in Tech for Pharma & Business Development | Busines Angel (Biotech / Medtech), 321funded