A Seminars

09:30 - 10:30

Bridging the Skills Gap in the Pharma Industry

Speakers

  • Amy Dillon Skills Enhancement Tutor - Edinburgh Napier University
  • View full profile for Dr David MincherDr David Mincher Senior Lecturer, School of Applied Sciences - Edinburgh Napier University
10:30 - 11:30

Break and Exhibition

11:30 - 12:00

Multifaceted Functionality of Micro- and Nano-Systems in Health

Speaker

12:00 - 12:30

Academy of Pharmaceutical Sciences – Delivering Meaningful Impact From University Research – A Nanotechnology Tale!

Speaker

  • Dr Jonny Coulter Reader, School of Pharmacy, Material and Advanced Technologies for Healthcare - Queens University Belfast
12:30 - 14:00

Break & Exhibition

14:00 - 14:20

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.

Speaker

14:20 - 14:40

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).

Speaker

14:40 - 15:00

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.

Speaker

  • Shilpa Mistry Head of Pharma, UK and Ireland - Chemlink Specialities Ltd
15:00 - 16:00

Break & Exhibition

16:00 - 16:20

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.

Speakers

16:20 - 16:40

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.

Speaker

09:30 - 09:50

STYL’One Compaction Simulators : from Excipients/API Characterization to Scale-up Support

Compaction simulators offer the capability to replicate tablet compression parameters at production scale right from the development steps - using minimal material quantities. This presentation will focus on the fundamentals of compaction simulator design and will present several case studies around material characterization, formulation development, scale-up and troubleshooting of tablet defects. It will highlight the correlation between tablet properties produced on a compaction simulator and tablets manufactured on a high-speed production press, for single layer, multilayer and tab-in-tab application.

Speaker

09:50 - 10:10

Harnessing Raman Imaging to Boost Pharmaceutical Product Analysis, From Formulation to QC

Drug development is a long road with many dead ends to avoid. Part of the journey involves understanding the spatial distribution of active pharmaceutical ingredients (APIs) and excipients, investigating final product homogeneity and differentiating chemically similar molecules such as polymorphs, to guarantee product quality and to maximise process efficiency.
To ensure that the correct route it taken, it is critical that engineers and researchers have the best possible instrumentation. Enter Raman imaging microscopy.
This talk outlines how Raman imaging can assist throughout the development and production process, from drug discovery to product formulation and will also touch on post-marketed investigation.

Speaker

  • Adam Holland Senior Raman and µPL Product Manager - HORIBA UK Ltd
10:00 - 10:30

Academy of Pharmaceutical Sciences – Smart Nanotherapeutics for Pancreatic Cancer Therapy

Speaker

10:10 - 10:30

Digitalization of Particle Monitoring in the Cleanroom to Enhance your Contamination Control Strategy

How do you upgrade your manual particle counting environmental monitoring program to reduce risk of transcript errors, reduce time consuming paper trails, reduce labor and to automate your cleanroom monitoring so your data integrity is intact and meets 21CFR11 compliance?

Speaker

10:30 - 11:30

Break & Exhibition

11:00 - 11:20

PMTC Approach to Understanding the Pharmaceutical Cleaning Process

Pharmaceutical cleaning and subsequent verification and validation have always been time consuming and a costly operation in multipurpose pharmaceutical plants. It has a significant impact on plant efficiency, utilities and resources. About 50% of time is spent doing cleaning, resulting in a massive impact on downtime, costs and changeovers. This presentation will cover the PMTC approach towards understanding the cleaning process in order to develop efficacious cleaning procedures and robust verification methods. It will also cover the benefit of the use of PAT tools for real time monitoring and verification of cleaning to reduce the cleaning times, costs and wastes and to develop more sustainable processes. The methodology is based on computational and experimental methodologies to optimise the cleaning processes and offers a deep understanding of the mechanisms by which the residues are removed. The implementation of the method in industrial setting helped the centre achieving very impactful outcomes by reducing the changeovers by ~10% /year, solvent usage by ~40% and changeover times by an average of two weeks.

Speaker

11:20 - 11:40

Computational Studies of Surface Cleaning by Flowing Solvents

This presentation will show how computational fluid dynamics studies can be applied to determine the cleaning rates of vessels used for pharmaceutical production. During changeover between batches of different products, vessels are often cleaned with solvent sprays. To reduce solvent and energy use and transition to greener solvents, there is a need to understand the rates at which surfaces are cleaned by flows of pure solvents and mixtures. Simulations of film flows will be presented and compared with experimental findings. Computational predictions of solvent distribution and cleaning rates could be used to optimise the selection of cleaning agents and methods.

Speaker

  • Dr Orest Shardt Lecturer in the School of Engineering - University of Limerick
11:40 - 12:00

Application of Visible Residue Limits in Cleaning Validation

Speaker

  • Dr Conor Collins Head of Validation / Product Lifecycle Management for Pharma Supply - GSK
12:00 - 14:30

Break & Exhibition

14:00 - 14:20

SSPC _4

14:20 - 14:40

SSPC _5

14:40 - 15:00

SSPC _6