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Lyophilization process design for a given formulation. Principles of process scale up and transfer, introduction to the design space
October 25, 2019
Lyophilization process design for a given formulation. Principles of process scale up and transfer, introduction to the design space

Workshop will provide insights in the development of lyo-friendly formulations and lyophilization process design using Excel based primary drying model. Attendees will be also introduced to the process of inputs generation for the primary drying model, while accounting for the differences in scale. Primary drying model and formulation design templates will be provided to the attendees with the demonstration of their functionality.

FEATURED SPEAKERS

Serguei Tchessalov

Serguei Tchessalov

Research Fellow, Pfizer Inc.

Serguei Tchessalov

Research Fellow, Pfizer Inc.
Serguei Tchessalov

Dr. Serguei Tchessalov is a Research Fellow at Pfizer Bio Therapeutics R&D (Andover, MA). He received his Ph.D. from Institute of Applied Biochemistry (Moscow) on development of novel methods for formulation and process control during lyophilization. He completed his Post Doctoral training with prof. Pikal (UCONN). For the past 30 years (both, in Russia and US) Dr.Tchessalov is working on formulation and lyophilization process development of bacterial and viral vaccines, proteins and different biological materials. His current research is focused on lyophilization process scale up and transfer as well as processing of parenteral dosage forms (filtration, filling, freezing/thawing and etc).

Workshop agenda

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13:30

Registration & Coffee

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14:00

Session 1

• Introduction to the primary drying model
• Measuring of vial heat transfer coefficients Kv
• Estimation of dry product resistance Rp
 

Serguei Tchessalov, Research Fellow, Pfizer Inc.

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15:00

Session 2

Serguei Tchessalov, Research Fellow, Pfizer Inc.

• Demonstration of primary drying model
• Introduction to the design space
• Elements of process and product robustness studies
 

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15:40

Tea Break

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16:10

Session 3

Serguei Tchessalov, Research Fellow, Pfizer Inc.

• Lyo formulation 101
• Demonstration of formulation design template
• Impact of formulation on cycle
 

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17:10

Session 4

Serguei Tchessalov, Research Fellow, Pfizer Inc.

• Differences between scales: impact on lyophilization process
• Examples of model applications for the process scale up and transfer, assessment of impact of deviations on the product quality
• Impact of process tolerances on cycle duration
 

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18:00

Closing Remarks and End of Workshop


Research Fellow
Pfizer Inc.

VENUE

Sheraton Boston Hotel

39 Dalton Street, Boston, MA, USA

Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
 

A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
HOTEL BOOKING FORM

Sheraton Boston Hotel

39 Dalton Street
Boston 02199
USA

Sheraton Boston Hotel

Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
 

HOTEL BOOKING FORM

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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.

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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, SAE Media 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.

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