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This is a one day workshop on the practical implementation of a Quality by Design (QbD) system for dealing with biopharmaceutical glycosylation in biomanufacturing.

Topics covered in the workshop include:

  • Relevance of glycosylation to the biopharmaceutical industry
  • Practical issues arising from the complexity of biopharmaceutical glycosylation
  • How biopharmaceutical glycosylation affects product safety and efficacy
  • How a well-designed QbD approach can save time and money in drug development and production
  • ICH guidelines and glycosylation
  • Introduction to GTO-QbD - a graph theoretic framework that simplifies implementation of QbD for glycoprotein therapeutics 
  • How GTO-QbD helps determine the biological relevance of glycosylation features in a particular antibody
  • Determining Glycosylation Critical Quality Attributes (GCQAs) for biopharmaceuticals using impact maps that relate glycosylation attributes and biological activities to product safety and efficacy
  • Key principles of a QbD framework, Design Space (DS) and glycosylation, Glycosylation Critical Quality Attributes (GCQAs)
  • How to determine GCQAs for your therapeutic
  • Determining glycoprofiles to measure the GCQAs for your drug
  • Choosing appropriate glycosylation parameters to demonstrate comparability of drug glycoforms
  • Dealing with alterations in glycosylation througout the product life cycle and after manufacturing changes;
  • Glycoprofiling using orthogonal analyses based on HPLC, CE and MS
  • Ensuring comparability of glycoprofiling data throughout product development and manufacturing
  • Case studies - examples of QbD applied to glycosylation of therapeutic antibodies, EPO and reproductive hormones

Speaker Profiles

Dr. Daryl Fernandes, founder and CEO of Ludger Ltd, Oxford, UK

Daryl has over 25 years experience in developing and using glycoanalysis techology.  He gained his doctorate at the Glycobiology Institute, University of Oxford in the 1980s, was a consultant on biopharmaceutical glycoprofiling to Monsanto and G.D. Searle and helped spin out Oxford GlycoSciences (OGS) from the University.  He joined OGS as Process Development Manager and then as the Head of Analytical Services.  Daryl left OGS to set up Ludger in 1999.  Ludger has laboratories at the Culham Science Centre near Oxford, UK and develops technology to measure and control biopharmaceutical glycosylation throughout the drug life cycle.  Daryl's research interests include the development of graph theoretic systems for analysis of complex glycosylation in biologics and high throughput glycoprofiling methods to support new drug development.

Dr. Claire Morgan is Business Development Manager at Ludger Ltd. She is responsible for liaising with clients prior to project set up as well as the company's marketing campaign. Claire has a background in Immunology, having gained her PhD at The Royal London Hospital and Post Doctoral research experience at the Anthony Nolan Bone Marrow Trust (the Royal Free Hospital, London) and St. Bartholomew's Hospital, London. Before joining Ludger years Claire was in charge of Marketing and PR for the scientific events company EuroSciCon. 
 

Workshop programme

9:30 Registration and coffee

10:00 Welcome and introductions

10:10 Workshop sessions

12:30 Lunch

13:30 Workshop sessions

16:00 Close of workshop

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Copthorne Tara Hotel

Scarsdale Place
Kensington
London W8 5SR
United Kingdom

Copthorne Tara Hotel

The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

 

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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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