26 April 2022 Seminars

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
9:30 am - 9:45 am

BASF Pharma Solutions – Making Life Easier

An overview of BASFs tools and products and how they can reduce development times, simplify production, and support registration.

Speaker

9:30 am - 9:50 am

Combatting the COVID-19 Pandemic – The Role of Phospholipids

Speaker

9:30 am - 9:50 am

Using Digital Data and Analytics to Problem Solve When Manufacturing Pharmaceuticals

Speaker

9:30 am - 10:10 am

What are the Differences in Responsibilities Between a RP, QP & RPi?

Speaker

9:50 am - 10:10 am

EfferShield: A Disruptive Innovation for Manufacturing and Packaging of Effervescent Products

Speaker

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

9:50 am - 10:10 am

Project Management to Enable Digitalisation – How can Project Managers Deliver Projects Which are Future Proofed for New Digital Incentives.

Speaker

9:55 am - 10:10 am

Covering Supply Security for Excipients Today

From Brexit to Covid, unexpected disruption and delays to the manufacturing supply chain is now a common occurrence. HARKE Pharma has demonstrated an ability to mitigate impacts from this with long lasting customer and supplier relationships, contingency planning, and close communication between all parties. This connectedness is what will keep the Pharmaceutical industry on track and on time.

Speaker

10:00 am - 10:30 am

 Healthcare Distribution Challenges with GDP Regulations during the Pandemic

Speaker

  • Geoff Mellor Technical Director - Healthcare Distribution Association UK
10:00 am - 10:50 am

Demonstration by NPC

SherpaPharma Environmental Monitoring Software

Cloud-based, software solution to streamline the EM micro process.

The Demonstration will clearly show the ease of use of the system and how a truly paperless cloud-based software solution can bring reliable and effective environmental monitoring. We will present the systems capabilities from the entering of data to the speed of producing all types of reports at lightning speed.

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

10:10 am - 10:30 am

Impact of Climate Change on Pharmaceutical Manufacture

Speaker

10:10 am - 10:30 am

Introduction to Down Streaming Using HPMCAS

Speaker

  • Shilpa Mistry Head of Pharma,UK and Ireland - Chemlink Specialities
10:10 am - 10:30 am

The Cleaning Challenge with Pharma Excipients

APIs (Active Pharmaceutical Ingredients) and their solubility in water are often used as the rationale to identify the worst case product. According to Annex 15 (10.10) the criteria for determining the worst case may include solubility, cleanability, toxicity and potency. The cleanability of a product can also be driven by the excipients used. This presentation will identify excipients that can cause cleaning challenges (e.g. Carbomers, TiO2 and other pigments) and discuss ways to resolve the issues.

Speaker

10:20 am - 10:35 am

Improving Your Cleanroom Surface Cleaning Processes – Reducing Risk and Costs

This presentation will discuss potential risks associated with high touch points along the surface cleaning process.  It will also introduce new technologies to reduce risk as well as improve operational efficiency and compliance.

Speaker

10:30 am - 11:30 am

Break

10:30 am - 11:30 am

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10:30 am - 11:30 am

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10:30 am - 11:30 am

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10:30 am - 11:30 am

Break

10:45 am - 11:00 am

UpperNoseTM: Developing Nasal Drug Products From Feasibility to Clinic

Providing a rapid pathway from feasibility to clinical trial supply for liquid and dry powder nasal products.

Speaker

11:10 am - 11:35 am

Driving GDP Compliance for Outsourced Logistics Activities

How JensonR+ can support you in qualifying your supply chain, validation of the hauliers and the importance of auditing.

Speaker

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
11:30 am - 12:20 pm

Demonstration by Chemlink Specialties

Topical formulations now made easier with a new rheology modifier

Creams, Emulsion, Ointment, Paste, Lotion, Wound dressing, Gel Patches, Carbomers

Currently carbomers are only used in pharma as rheology modifiers. A significant drawback of using carbomers is that you must neutralize with sodium hydroxide / potassium hydroxide etc. at a narrow pH range – many pharmaceutical companies face this issue when formulating topical formulations or semi solids.

We have a number of products that can help you improve the topical formulations, increasing viscosity at very low concentrations, improving the adhesion on the skin and flexible films, etc. If you have API which faces issues in dispersibility, we have excipients which can improve your formulation.

11:30 am - 12:20 pm

Demonstration by Crest Solutions

CXV Global SmartFactory LineClearance Assistant™ digitalises the line clearance process to enable clients in regulated industries to deliver products to market with maximum efficiency and quality.

LineClearance Assistant™

·       Reduces inspection times by up to 85%
·       Up to 20% capacity utilisation improvement possible
·       Builds bank of evidence each time a Line Clearance is performed
·       Return on investment in as little as 3 months
·       Dramatically improves OEE%

 

Crest Solutions, a CXV Global company will be demonstrating LineClearance Assistant in the demonstration area at 11.30am on the 26th & 27th April.

 

Click the link below to find out more about LineClearance Assistant Line Clearance | Life Sciences Manufacturing & Packaging | CXV Global

11:30 am - 11:50 am

Digitalisation to Improve Knowledge Management

Speaker

11:30 am - 12:30 pm

MMCS – Introducing a New Route to Pharma GDP Compliance and Standardisation

The British Standards Institution (BSI) and Poseidon have come together to create a new GDP platform to champion the development of global GDP standards, efficient quality management systems, mutually-recognised assessment schemes, supply chain best practice and the provision of professional guidance through the growing maze of GDP regulations. The Multi-Modal Compliance and Standards (MMCS) program, a  'first-of-its-kind', is providing a consensus-based foundation on which to build the common GDP standards and GDP guidance needed for the safe, efficient and compliant transportation of vital pharmaceuticals in the virus age.

The presentation will be relevant to anyone involved in the storage, distribution and quality management of medicines - manufacturers, distributors, LSPs, carriers, suppliers etc - in any capacity or transport mode.

Speakers

11:30 am - 11:50 am

Serialisation Operating Models for Different Supply Chain Partners

Speaker

11:30 am - 11:50 am

Strategic API Procurement – How to Choose a Source That is Right for You

Speaker

  • Nick Carter Director / GDP Designated Person - Wessex Fine Chemicals
11:35 am - 11:50 am

Tableting Oily APIs

Dr Gernot Warnke is the global head of JRS Pharma's R&D. In this role, he is responsible for the world-wide network of JRS laboratories, which are offering technical support to customers, carrying out application studies and developing new products for JRS Pharma's portfolio of excipients and film coatings.

Speaker

11:50 am - 12:10 pm

Inspection Readiness and Responding to Different Audit Techniques

The session will be led by a former MHRA inspector and include tips for preparation and the inspection itself. The inspector or auditor will ask you questions in different ways to help them build up a picture of your compliance level. You will hear questions you might be asked and the right way to answer to demonstrate your compliance.

Speaker

11:50 am - 12:10 pm

Names, Logos, Branding, Regulated Content – How do you develop your packaging artwork for launch?

Speaker

12:00 pm - 12:40 pm

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

Speaker

12:10 pm - 12:30 pm

Auditing in the Pharmaceutical Industry

The different types of audits in the pharmaceutical industry. First, second and third party audits. Why we do these and their focus and priority. Training for auditors. Too basic?

Speaker

12:10 pm - 12:30 pm

Process Vessel Temperature Control Systems (How to Reduce Operational Costs and Improve Controllability)

Speaker

12:10 pm - 12:30 pm

The Impact of Electronic Patient Leaflets on Information Management and Product Supply

Speaker

12:25 pm - 12:40 pm

Contaminants in API and Drugs, an Emerging Problem into Pharma Sector

The problem related to the contamination of APIs and FP has become increasingly topical in the last few years. The aim of the speech is to describe different analytical approaches in the monitoring of contaminants in the pharmaceutical field through some case studies.

Speaker

12:30 pm - 2:00 pm

Break

12:30 pm - 2:00 pm

Break

12:30 pm - 2:00 pm

Break

12:30 pm - 1:00 pm

Workshop: MMCS – Introducing a New Route to Pharma GDP Compliance and Standardisation

Speakers

12:50 pm - 1:05 pm

Challenges and Opportunities for a UK CDMO in Turbulent Times

This topic covers the requirements in setting up a successful CDMO in the UK.

Speakers

12:50 pm - 1:10 pm

Child Safe Packaging and the Impact on the Eldery

Speaker

1:00 pm - 2:00 pm

Break

1:00 pm - 1:50 pm

Demonstration by HORIBA UK

Duetta: Absorbance and Fluorescence - in the blink of an eye

Join us to discover Duetta™, the spectrofluorometer that combines, simultaneously, the functions of fluorescence and absorbance spectrometers. Thanks to its high-speed built-in CCD detector, you will witness the fastest fluorescence spectrometer on the market performing full spectrum acquisitions from 250 nm to 1,100 nm in less than one second.

 

1:00 pm - 1:50 pm

Demonstration by Protak Scientific

Protak Scientific Enzyme Indicators

Cycle efficacy testing with Enzyme Indicators, the faster, smarter & safer way

Join us as we demonstrate how Enzyme Indicators are used, tested and analysed to achieve a greater understanding of gaseous decontamination cycle efficacy than that of conventional methods that can be shown in minutes rather than days.

1:10 pm - 2:00 pm

Break

1:15 pm - 1:30 pm

Maintaining Regulatory Compliance; a Proactive Approach

This session consolidates industry learnings from poor GMP compliance, adverse inspections and how to proactively avoid this situation.

Speakers

1:40 pm - 1:55 pm

Concept to Commercialisation in Six Weeks During Covid Times

This presentation covers the creation of a new business and product range and how challenges were overcome.

Speakers

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

2:30 pm - 3:20 pm

Demonstration by Bonfiglioli Engineering

Bonfiglioli Engineering

Demonstrating the NEW – LT-Pro (High Accuracy), Non-invasive, non-destructive leak tester for laboratory and in-process control applications. Provides accurate and reliable closed container integrity testing (CCIT) for rigid and flexible packaging.
Vials, ampoules, BFS, FFS, bottles, prefilled syringes, carpoules, cartridges, trays, pouches, sachets, flowpacks, cups, and other flexible and semiflexible filled-and sealed packaging

2:35 pm - 2:55 pm

Pharmaceutical Innovation – Enzymes

Screening and engineering of enzymes with tailor-made properties as well as enzymatic synthesis of key intermediates and active pharmaceutical ingredients.

Speaker

3:00 pm - 3:45 pm

Break

3:00 pm - 4:00 pm

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3:00 pm - 4:00 pm

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3:00 pm - 3:30 pm

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3:00 pm - 3:45 pm

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3:00 pm - 3:15 pm

What Automation Can and Should Deliver

A presentation of what automation can and should deliver and how the end user should ‘construct’ their URS. The process should be more consultative as the automation solution supplier constantly works on a variety of automation solutions. Work in partnership for better results!

Speaker

3:25 pm - 3:40 pm

Isolation Technology Trend and New Challenges – a Case Study

Production flexibility, continuous manufacturing and low nanogram level of containment will be discussed going through the design aspects of a recent installation.

Speaker

3:45 pm - 3:55 pm

APS Emerging Technologies Focus Group

Speakers

  • Prof Clive Roberts Vice Chairman - Academy of Pharmaceutical Sciences Emerging Technologies Focus Group
  • Dr Dimitrios Lamprou Reader in Pharmaceutical Engineering - Queens University Belfast
3:45 pm - 4:45 pm

Collaborative Innovation to Drive Progress- How Can Working With Others Speed up Your Innovation

Speaker

  • Dr Dave Berry Grand Challenge and Digital Strategy Lead - Centre for Process Innovation
3:45 pm - 4:05 pm

Introducing UltraBurst™ a Novel Excipient that Addresses the 3 Most Important Success Factors for ODTs

Speaker

3:45 pm - 4:05 pm

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

Speaker

3:45 pm - 4:45 pm

Quality Risk Management in GDP

Speaker

  • Neil Wayman Secretary - Pharmaceutical Quality Group (PQG)
3:55 pm - 4:15 pm

Emerging Technologies in Pharmaceutical Manufacturing

Speaker

4:05 pm - 4:25 pm

Air and Water Microbial Monitoring

Speaker

  • John Cobb Company Microbiologist - PMT (GB) Ltd
4:05 pm - 4:25 pm

Formulating Pharmacokinetics

Speaker

4:15 pm - 4:45 pm

The Potential for Additive Manufacturing in Pharmaceutical Production

Speaker

4:25 pm - 4:45 pm

Digitalising Line Clearance – Presentation Summary

Speaker

4:25 pm - 4:45 pm

Marketing LifeSciences; Successes and Learnings

Speaker