Conference Room D Programme

26 April

9:30 am - 9:50 am

A Guide to Outsourced Stability Storage

Manufacturers conduct Stability Studies to establish shelf life. Shelf life of a product is ascertained under controlled environmental conditions such as humidity, temperature or light. Stability studies are an evaluation of the risk of product degrading in different markets within different climatic zones. Stability studies are important as the manufacturer has responsibility for the product from formulation to consumption and must ensure that the formulation does not lose its potency or result in degradation by-products that can do more harm than good to the consumer. The shelf life of a product is typically assessed either by real-time or accelerated stability trials. The stability programme should also examine factors that influence its quality, for example, interaction of API with excipients, container closure systems and packaging materials. Join Wendy to find out more about Stability Storage.  

Speaker

  • Wendy Cullen Head of UK Sales - Stability Storage - Source Bioscience

9:50 am - 10:10 am

Particle Engineering to Optimise the Performance of Inhaled Therapeutics

The ability to access the large surface area of the lung makes pulmonary delivery an increasingly attractive option, not only for treating respiratory diseases but also to target rapid systemic uptake. To maximise delivery to the lung, however, particles must have tight size distributions and be easy to aerosolise. Traditional approaches to achieving the necessary requirements for inhalation (e.g. micronisation) often lead to undesirable properties which negatively impact stability and lung deposition, as well as introducing formulation complexity. This presentation will describe alternative strategies that facilitate the rapid development of optimised inhaled therapies, including the application of supercritical fluid technologies.

Speaker

10:10 am - 10:30 am

How to Accelerate Drug Product Development of Sensitive APIs with a Novel Ready-to-fill Capsule

Nina Hauschildt as explains how  novel ready-to-fill capsules optimize a drug’s release profile, protect active ingredients, and reduce clinical risk. Key takeaways
  • Offers a solution to  challenges in targeted drug delivery
  • Case studies the use of more active ingredients which are sensitive to heat, moisture or gastric acid
  • Reduces risk and speeds up time to market for early stage drug development
  • Provides a flexible range of custom options such as choice of size, colour and release profiles
 

Speaker

10:30 am - 11:30 am

Break

11:30 am - 12:00 pm

Biopharma’s Growth Story: Ten Key Themes

Speaker

  • Dr Duncan Emerton Executive Director, Custom Intelligence & Analytics - Informa Pharma Intelligence

12:00 pm - 12:40 pm

How to Effectively Manage a Remediation Programme and Sustain Quality Improvements’

Speaker

1:00 pm - 2:00 pm

Break

2:00 pm - 3:00 pm

KEYNOTE in ROOM A: Pharma – Balancing Compliance and Charitable Efforts

A former MHRA inspector's experience showing different expectations of the UK Pharmaceutical industry. On the one hand, the licence holder has a desire to respond to humanitarian need. On the other hand, they meet many challenges and must still achieve compliance and exercise due diligence. Can we resolve this dilemma?  

Speaker

3:00 pm - 3:30 pm

Break

3:45 pm - 4:05 pm

IP Protection in the Life Sciences – AI, 5G, AM and Beyond

Speaker

4:05 pm - 4:25 pm

Formulating Pharmacokinetics

Speaker

4:25 pm - 4:45 pm

Marketing LifeSciences; Successes and Learnings

Speaker

27 April

9:15 am - 9:35 am

How to Approve EXCiPACT as a 3rd Part Audit Provider

Speaker

9:35 am - 9:55 am

Application of EXCiPACT GMP to Excipient-like Materials Used in Pharmaceutical Drug Product Manufacture

Speaker

10:45 am - 11:30 am

Break

12:00 pm - 12:30 pm

GAMP 5 and Data Integrity – Trends for Manufacturing Systems

In recent years there has been concern about the integrity of the data used to release pharmaceuticals from the manufacturing stage to the market. This presentation takes a look at the current guidance on how to identify threats to this data, and how to ensure the data is not compromised. The presentation explains ‘Data Integrity’,... Read more »

Speaker

  • Hilary Mills-Baker European Quality and Validation Manager - Emerson Automation Solutions

12:30 pm - 2:00 pm

Break

2:00 pm - 2:20 pm

Dessicants and Sustainability in Active Packaging

Speaker

2:20 pm - 2:40 pm

Driving GDP Compliance for Outsourced Logistics Activities

Speaker

2:40 pm - 3:00 pm

Why the Future is Flexible in CDMOs

For pharmaceutical contract drug manufacturing operations (CDMOs), flexibility is key. An informed specification plays a big part in CDMOs being able to adapt to new projects. Using modular and bespoke furniture provides manufacturers with the ability to rapidly reconfigure their cleanrooms and production spaces to allow for each different contractual requirement. The ability to maintain... Read more »

Speaker