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• Reviewing characteristics of developed products to determine what tools are needed
• Assessing alternative routes, such as biologics and microbiome – what is needed for and the design needed for administration?
Speaker: Lonza Capsules & Health Ingredients
• The Importance of Patient Input in Drug Formulation
• Enhancing Drug Delivery Systems for Patient Convenience and Adherence
Speaker: Sven Stegemann, CEO, Leibniz JointLab
With the industry shifting to become more sustainable, it is crucial for both end-users and vendors to work together when sourcing greener raw materials. Join and learn about the need for global collaboration and what you can do to adopt green chemistry practices to your business:
• What are the greener alternatives for API production?
• A necessary investment – sustainability as a long-term growth opportunity
• Incorporating sustainability throughout the production lifecycle
Speaker: Juan Colberg, Senior Director Technology & Innovation, Global Green Chemistry Leader, Pfizer
• Performance management and continual improvement
• Reviewing current principles of quality in API manufacturing
• Breaking down manufacturing and operational strategies to determine the best outcomes
• Inventory and risk assessment
Speaker: Reserved - Medicines for Europe
• Market outlook – what's next for generics?
• Tackling shortages with fresh formulation approaches
• Driving quality improvements through process control optimisation
Juan Colberg, Senior Director Technology & Innovation, Global Green Chemistry Leader, Pfizer
1st Nov 10:30 - 10:55 Stand 30J20, Hall 3.1- Keynote
More than 75 % of new chemical entities are poorly soluble and require bioavailability-enhancing excipients. The application of excipients in advanced pharmaceutical processes, such as hot melt extrusion and 3D-printing, aligned with advanced approaches towards personalized medicine, requires special features. Lipid-based excipients (LBEs) are “natural contenders” for these tasks. However, until now, it has not been possible to fully exploit the potential of LBEs.
The main challenge is the unstable solid state of current LBEs, e.g. polymorphism, leading to instability of the final dosage form. Compared to polymers, the low melting temperature of lipids, combined with highly crystalline arrangement, limits their application in advanced pharmaceutical processes such as hot melt extrusion and 3D-printing.
1st Nov 11:00- 11:25 Stand 30J20, Hall 3.1
In recent years, the standardization of biologics manufacturing processes has given product developers multiple viable options for producing biologics. These options include building an in-house production system or partnering with a contract biologics manufacturer. Although building in-house does offer the advantage of direct control; the time, labor, and spend required to implement this often makes it the inefficient choice. On the other hand, working with an experienced contract manufacturer can help you save time and costs by leveraging a deep pool of industry experience. However, the process of selecting the right CDMO partner needs to be performed after careful analysis of many factors: any of which, if overlooked, can create risk of delay or cost overrun. In this session, we will discuss the key parameters that you can easily assess when choosing the right innovative CDMO partner that will keep you competitive in a rapidly evolving market.
1st Nov 11:30- 11:55 Stand 30J20, Hall 3.1
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 – device combination product development. Several methods exist with different advantages and limitations.
During this session, we will address the following points:
- Probabilistic vs deterministic CCI Testing
- Presentation of the different deterministic CCI testing methods with applications and limitations
- What to consider when selecting CCI testing method.
At the end of the session, attendees should better understand 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.