Gerresheimer is a system solution provider with a unique portfolio of pharmaceutical packaging solutions including drug delivery systems. High product quality in standardized format are key factors to enable an efficient and reliable fill & finish process. Gerresheimer offers a comprehensive vial portfolio to address this points: high quality Gx® Elite and Velocity® Vials. Securing the vial quality with superior dimensional consistency combined with reduced particle generation are some of the customer benefits of Gx® Elite and Velocity® Vials. EZ-fill SmartTM: introduction of this enhanced RTF packaging platform with superior features like low particles and optimized packaging to address processing and sustainability needs.

 

Speaker: Holger Krenz, Vice President Global Business Development High Value Products, Gerresheimer AG

During the lifecycle of an API many innovations are undertaken to manufacture in the most efficient and cost effective way, preferable not changing the actual Route Of Synthesis. However, over the years due to new chemistry, new technology and/or new equipment also so called second generation (2G) routes towards an API might be developed. In this talk several innovative 2G examples will be given.

Speaker: Dirkjan van Zoelen, Manager Development and Technical Support, Aspen API

Session Description: Blow-fill-seal (BFS) technology is being explored for one-dose presentations of vaccines and other biologics, providing a continuous, automated process that can lower manufacturing costs, increasing access for patients worldwide.  Other BFS benefits for biologics developers include enhanced automated processes with minimal human intervention, lower risk of foreign body contamination, and a high level of container integrity control during fill and finish. Manufacturers also appreciate the minimised risk of breakages during shipping and improved administration usability for clinicians and patients. However, implementing BFS for biologics and vaccine projects comes with challenges:
 

• Ensuring chemical and physical compatibility of the container and the overall blow-fill-seal process with the drug formulation 
• Demonstrating effective drug stability within the container
• Determining acceptable extractable and leachable profiles.
• In this session, we will explain how vaccine and biologics developers can overcome these challenges to harness the BFS manufacturing efficiency and patient convenience benefits.

Speaker: Vincenza Pironti, Director Strategic Marketing, Recipharm

• OXYCAPT Multilayer Plastic Vial for Biologics and Gene/Cell Therapy
• High Oxygen, CO2 and UV Barrier suitable for Biologics and Gene/Cell Therapy
• Extremely Low Inorganic Extractables Suitable for Biologics and Gene/Cell Therapy
• New Container Closure Integrity (CCI) Data at Deep Cold Storage (-80 degree C)

• (AGELESS Oxygen Absorber)
• Per- and polyfluoroalkyle Substances (PFAS) regulations in the European Union and the United States for their toxicity to humans and the environment.
• AGELESS Oxygen Absorber for pharmaceuticals and medical devices.
• Necessity of oil/water resistance for the oxygen absorber to perform properly and a challenge of eliminating PFAS.
• Introduction of a new AGELESS complied with PFAS regulations without compromising performance, quality or safety.
• The only one product which achieves PFAS free and oil/water resistant packaging."

Speakers:
Yoshiko Sakuma, Researcher, Mitsubishi Gas Chemical Company, Inc.

Risa Watanabe, Researcher, Mitsubishi Gas Chemical Company, Inc.

The first alert from regulatory authorities was in mid-2018 when nitrosamine impurities - including N-nitrosodimethylamine (NDMA) - were detected in sartans-based pharmaceutical products. This triggered a series of global-scale investigations that led to the revelation of the presence of other low molecular weight N-nitrosamines in many APIs and finished products, sometimes forcing companies to recall products. Successively, a new risk was highlighted related to the formation of NDSRIs from APIs (or their related impurities) containing vulnerable amine groups during finished product formulation/storage due to the reaction with residual nitrite present in some raw materials. This new emerging issue affected several drug products on the market, stimulating the Competent Authorities to push for a review of the original risk assessment in light of this new information performing step 2 confirmatory testing as appropriate. 
 

Our scientific expert will talk about:
 

• NDSRIs emerging issues
• Analytical challenges during method development and QC tests on NDSRIs
• Case studies from Mérieux NutriSciences Pharma Nitrosamines Labs

Speaker : Sergio Fasan, Business Director, Mérieux NutriSciences

Alcohol hangover symptoms are unpleasant and once they develop are difficult to alleviate, adversely affecting daily activities. The dietary supplement Al cofiltrum has been clinically proven to effectively and proactively alleviate the severity of these symptoms, and can thus be helpful for people who are prone to develop these symptoms after consumption.  

• Alcofiltrum contains four natural components lignin hydrolyzed, glycine, dihydromyricetin, and thiamine each of which helps the body to combat excessive alcohol consumption.  
• Lignin hydrolyzed, the main component of Alcofiltrum, is an insoluble dietary fiber with high sorption capacity against a variety of toxic substances, including acetaldehyde, and fusel alcohols that contribute to hangover symptoms.  Lignin also has antioxidant properties and water holding capacity further limiting alcohol intoxication symptoms.
• Dihydromyricetin counteracts acute ethanol intoxication by antagonizing ethanol’s potentiating on neuron cells, glycine is a neurotransmitter essential for nervous system function, and Thiamine contributes to normal energy-yielding metabolism which is impaired in alcohol hangover.

Speaker: Lefteris Zacharia, R&D manager, AVVA Pharmaceuticals Ltd

Highly Potent APIs are a rapidly growing segment of the global pharmaceutical industry, and they are acquiring a significant relevance into the development space. The importance to understand the challenges around development of High Potency Oral solids formulations, are the key to ensure a right scale-up and launch

• Risk-based approach: measuring the risk, not the hazard
• Challenges for High potency products handling. Importance of select the adequate partner 
• Development of secure and scalable process in high containment environment

Speaker: Carolina Bonifacio, Head Drug product Development Barcelona, Siegfried

After years of investment in R&D, 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 pharmaceuticals drugs stored at deep cold temperatures. The attendees will have the chance to learn about the benefits of two SCHOTT Pharma innovations: TOPPAC® freeze, a polymer syringe suitable for deep cold storage down to -100°C, and EVERIC® freeze, a glass vial, with optimized strength for deep cold applications down to -80°C.

Speakers:
Victoria de la Torre, Global Product Manager, SCHOTT Pharma AG & Co. KGaA

Michael Weber, Head of Business Development, SCHOTT Pharma AG & Co. KGaA

Scilife proposes a new quality paradigm that goes beyond the boundaries of traditional compliance-focused quality. The paradigm is based on Smart Quality and a company-wide commitment to quality. Immersed in this innovative approach, Filip Heitbrink, CEO of Scilife, will present the first real "Smart Quality" Platform in the world. With Scilife, Life Sciences companies manage quality in a way that their quality management system (QMS) becomes a competitive advantage. Scilife integrates gamification and continuous learning with dynamic quality management tools and insightful data. Scilife’s solutions enable life science organizations to accelerate time to market and reduce the total cost of quality assurance. With a Smart Quality mindset, employees are equipped to leverage quality as a catalyst for value and optimize quality processes while mitigating compliance risks.

 

Speaker: Filip Heitbrink, CEO, Scilife

GELITA introduces its latest innovation EASYSEAL®: a pharmaceutical grade Softgel gelatin, that improves capsule seams and helps Softgel manufacturers to

• Significantly reduce leaking Softgels
• Manufacture with higher machine speed
• Increase Yield
• Reduce production costs
• Enable fills that usually cause high leaker rates (e.g. Lecithines)
• Manufacture resource-efficiently
• Not waste expensive fills
• Avoid cleaning capsule batches

Join the presentation to learn how to revolutionize your Softgel production by changing only one parameter: the Gelatin.

Speakers:

Jessica Pfoehler, Global Marketing, GELITA

Holger Becker, Head of Global Application Technology & Product Development, GELITA 

In this presentation, attendees will learn about the profound impact of pre-sterilized and pre-washed vials, commonly known as ready-to-use (RTU) vials, on enhancing patient safety. The speech emphasizes how RTU vials contribute to a reduction in contamination risks, thereby decreasing the potential for product recalls and ultimately infections. By eliminating the need for laborious process development, validation, and quality control, RTU vials streamline processes by implementing highly standardized and effective sterilization and washing procedures directly into the product. Thus, saving valuable time and resources for pharmaceutical companies. Based on case studies, the healthcare benefits of implementing RTU vials in various pharmaceutical operations will be illustrated. Attendees will gain insights into how this approach not only elevates product quality but also plays a pivotal role in upholding patient safety standards.

Speaker: Victoria de la Torre, Global Product Manager, SCHOTT Pharma AG & Co. KGaA