27 September Seminars
Dynamic Role and Impact of Precision Medicine in the Pharmaceutical Sector
- Dr. Sudipto Das Star Research Lecturer - Pharmacy and Biomolecular Sciences, RCSI
Digital Health Tools Creating Value in Pharma
- Dr Rob Argent Lecturer in Digital & Connected Health School of Pharmacy & Biomolecular Sciences - RSCI
Break & Exhibition
Multifaceted Functionality of Micro- and Nano-Systems in Health
- Dr Bahijja Raimi-Abraham Lecturer in Pharmaceutics - King's College London
The Value of the EXCiPACT Certification Scheme
- Iain Moore Ipec Europe / EXCiPACT
Academy of Pharmaceutical Sciences – Delivering Meaningful Impact From University Research – A Nanotechnology Tale!
- Dr Jonny Coulter Reader, School of Pharmacy, Material and Advanced Technologies for Healthcare - Queens University Belfast
The IPEC – PQG GMP Guide
- Adrian Bone Ipec Europe / EXCiPACT
Break & Exhibition
Enabling Decarbonisation of the Pharmaceutical Supply Chain
Sustainability is integral to everything we do. From the raw materials we source and the way we use them, to the ingredients we create, we believe in being a responsible company
By 2030 we will be the most sustainable supplier of innovative ingredients, helping to provide solutions to some of the world's biggest challenges.
Excipient manufacturers are making steps towards strengthening and ensuring a sustainable pharmaceutical supply chain through reducing use of fossil fuel energy sources, improving energy efficiency of manufacturing processes and purchasing raw materials from suppliers aligned to the net zero journey.
The transparency and consistency of reporting sustainability throughout the supply chain is imperative to its success.
- Christian Wells Lead Application Scientist for Pharma - Croda
Strategic API Sourcing – How to Choose a Source That is Right for You
- Nick Carter Director - Wessex Fine Chemicals Ltd
Surfactants in Bioformulation: Are We at the End or the Beginning of a Journey?
This presentation will review and highlight the importance of surfactants in the production and formulation of biological actives for the biopharma industry. It will introduce and explain BASFs approach to this key class of functional materials for the biopharma industry, and the impact of excipients on biologics formulations. It will also cover the effect on stability under different stress conditions and also discuss alternative surfactants polysorbate 20 and 80: Poloxamer 188 (Kolliphor® P 188 Bio), Kolliphor® HS 15, Kolliphor® ELP).
- Dr Philipp Hebestreit Technical Manager - BASF
Tableting Oily APIs
- Gernot Warnke Head of R&D - JRS PHARMA
A Convenient Formulation of Orodispersible Mini-tablets for Pediatric Administration
Orodispersible mini-tablets (ODMT) are a beneficial dosage form for pediatrics and geriatrics. Furthermore they can be used for flexible dosing in broader Patient Groups. A recent study to determine the suitability of agglomerated Isomalt, a Disaccharide alcohol, as a direct compression filler-binder for producing ODMT with hydrochlorothiazide and enalapril maleate, as model commonly used pediatric drugs, is described.
- Dr Michael Black Head of Pharma - Beneo Palatinit GmbH
Novel Excipients For Parenteral Formulations
Excipients are typically the major components in a drug product. Many formulations contain only a small percentage of the active drug molecules. Pharmaceutical excipients or additives are compounds added to the finished drug products to serve a specific function.
Injectable products require a unique formulation strategy. The formulated product must be sterile, pyrogen-free, and, in the case of solution, free of particulate matter. No coloring agent may be added solely for the purpose of coloring the parenteral preparation. The formulation should preferably be isotonic, and depending on the route of administration, certain excipients are not allowed. The injected drug by-passes natural defense barriers; hence, for any given drug, the risk of an adverse event may be greater or the effects difficult to reverse if administered as an injection rather than a non-parenteral route. For this reason ultra-high purity grades of excipients are available for parenteral administration. Sterility requirements demand that an excipient is able to withstand terminal sterilization or aseptic processing. These factors limit the choice of excipients available in the market. With the new products for Clariant the choice of excipients have increased for parenteral formulations and in the presentation we will discuss the new product range.
- Shilpa Mistry Head of Pharma, UK and Ireland - Chemlink Specialities Ltd
Break & Exhibition
Hygienic Seals – Insights Into Safe Pharmaceutical Production
Bio-films are difficult to remove, are often resistant to normal sanitation procedures, and can result in detrimental process effects. Even when a surface appears to be clean the presence of bio-films is a potential hazard that must be eliminated and prevented from reoccurring. The presentation gives insights into avoiding bio-film build up, and the benefits of hygienic seals in safe pharmaceutical production in line with European Hygienic Design Group guidelines.
- Neil Firth Business Development Manager - Garlock GB Ltd
What is the Right Entrance Solution For My Cleanroom? High Speed Doors or Automatic Doors?
A critical decision to secure the purity and safety of goods produced in controlled environments is how to seal off a Clean Room or Controlled Atmospheric Area.
This technology insight will cover door solutions for clean rooms including those with conveyor integration and robotics solutions. It includes the most modern touchless opening technologies to help the listener holistically evaluate the complete solution.
A discussion around Future Proofing Clean Rooms with the potential of Connected Door Solutions, integration per BUS Systems or with Building Management Systems, rounds off the digital potential of doors in a connected factory.
Assa Abloy is the global leader in the research, design, manufacture and support of a range of Automated Industrial and Commercial Doors.
Employing a team of over 50,000 globally, the customer is at the centre of everything we do.
- Derek Walsh ASSA ABLOY Entrance Systems Ireland
Benefits of Dry Granulation using Roller Compaction
In today's competitive Pharmaceutical markets, finding production cost advantages is essential. Dry granulation has in the past only been considered beneficial for heat or moisture sensitive products, however with the latest Roller Compactor technologies, this process can be used for a wide range of products.
The presentation will explain the principle of Dry granulation and compare it the more common Wet Granulation process.
- Fraser Gow International Sales Manager - Alexanderwerk
Regulatory Guidance on the Life Cycle Approach to Container Closure Integrity Testing
This presentation will look at the path of regulatory guidance over the last decade, in the context of container closure integrity inspection for pharmaceutical product packaging and help explain what this means across the manufacturing life-cycle.
We will cover why different approaches and justifications need to be considered for different stages of product development and manufacture and look at emerging technologies and where they fit across these various stages.
- Tim Commane Director of Life Science - IPP Group
Engineered Enzymes Facilitate Efficient Biocatalysis for the Sustainable Production of Chiral Amines
Biocatalysis provides great capabilities for the synthesis of interesting API (precursors) such as chiral amines. However, enzymes are often limited by the solubility of hydrophobic substrates in aqueous reaction environments. By employing enzyme engineering and switching the solvent system, these issues can be overcome, and very efficient reaction systems can be designed.
- Jan-Dirk Spoering Enzymaster
Industry 5.0 – Human Factors and Digital Technology
What is Industry 5.0? It places the wellbeing of the worker at the centre of the production process and uses new technologies to provide prosperity beyond jobs and growth while respecting the production limits of the planet.” – European Commission
One of the less fortunate features of current life sciences manufacturing is that the procedures and processes we expect personnel to navigate are often complex. We seldom design standard operating procedures with intuitiveness in mind. The complexity and cognitive inaccessibility of many traditional SOPs can result in human error.
Additionally, many SOPs are not written in a task-oriented way. Some examples we have seen even have steps in tasks out of sequence from the way in which they need to be done. Many SOPs tell people what to do, but not how to do it. This results in the development of tacit knowledge to manage the how.
This can result in deviations in practices over time and consequences for the business when the owners of important tacit knowledge leave for retirement or other employment. It can also result in different practices between individuals, teams or shifts.
The key is to have a system that deals with the three “C”s: how to Create your content, how to Curate it and how to Communicate it. When a system like that is in place, you have a much more human-centric environment, as will be seen when each of the three Cs is expanded on during this talk.
- Padraig Culbert CEO - Connect Academy