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About the Masterclass

Lyophilisation, or freeze-drying is a key practice within the Pharmaceutical industry, as it is necessary for the effective long term storage and transport of biologics and other sensitive materials. However, though the theory is simple the practice is often fraught with challenges and difficulties, as problems such as; optimisation of freezing and drying times; ideal buffer selection; pH fluctuations, and excipient choice can all complicate the lyophilisation process.
As the Biopharmaceutical industry continues to grow, and the market for lyophilised products is reported to exceed 150 million units in 2010, there is a definite need for new rapid and cost effective lyophilising methods for large scale commercial usage.

This Masterclass aims to address the problems encountered during the lyophilisation process, as well as examining why the theory does not always match up to reality. 

Key benefits of attending:

By attending this Masterclass, you will be able to;

  • Identify the problems within your practice
  • Develop your understanding of the lyophilisation process
  • Discover ways to improve your current approach
  • Expand your network of contacts working in the field of lyophilisation
freeze-drying

About the Masterclass Leaders:

Tony Auffret  is Chief Scientific Officer of taPrime Consulting , and has over 35 year of experience in academia and industry, in companies ranging in size from 1 person through to multinational giants.  Throughout a career encompassing protein structure and evolution, scientific instrumentation, biopreservation, and pharmaceutical materials science, he has been committed to creating, developing and managing innovation and science based industry.

 

taPrime Consulting, offers formulation and process development advice, and problem solving to the lyophilisation market .  It works on the premise that trial and error has no part in its business.

http://www.ta-prime.co.uk/

 

     Matthew Brown  is Director of R&D at Lyosolutions , and is responsible for all R&D activities, analytical work and preparation of reports. Prior to joining Lyosolutions Limited, Matthew spent four years at Harvard Medical School, Boston, USA, studying invasive mechanisms of pathogenic microbes.

Lyosolutions Ltd . is a specialist R&D company, with particular expertise in pharmaceutical product development and freeze-drying. They develop freeze-drying cycles and provide assistance during production failure, which primarily arises from cycle programmes that fail the technology transfer from R&D to production scale. However unusual your concepts or requirements we can be essential in finding the solution. http://www.lyosolutions.co.uk/ 

 

Masterclass programme

10:45 Registration & Coffee

11:00 Chairman's Opening Remarks

Tony Auffret

Tony Auffret, Freeze-drying consultant, taPrime Consulting

11:00 Welcome and introduction

Matthew Brown

Matthew Brown, Director of Research and Development, Lyosolutions Ltd

11:20 Group Discussion: Commonly encountered problems?

11:45 Group Exercise: Designing a process cycle

12:30 Cycle optimisation; the competing needs of development

13:15 What does the state diagram tell us about the edges of failure?

14:00 Networking Lunch

15:00 Group Exercise: Analysing a series of output charts

16:00 Afternoon Tea

16:20 Amorphous and crystalline states in freeze-dried products

17:00 Group Workshop: Avoiding commonly encountered problems

18:00 Close of workshop

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WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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