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Formulations for Pre-Filled Syringes
19 January 2010
Formulations for Pre-Filled Syringes

This workshop aims to cover key aspects associated with the formulation of biologicals for applications in pre-filled & dual chamber syringes.  The workshop will begin by looking at target product profile, to lay the foundation for discussion surrounding the subsequent development work, leading up to the final drug product and the key stages associated with that.  Attention will be given to challenging situations, such as the design of formulations for freeze-drying in dual chamber syringes.  Alongside these key considerations, time will also be spent on the selection process for primary packaging components and different devices.  Design of Experiments (DoE) and Quality by Design (QbD) in formulation development will also be included in this informative programme.

Topics to be covered include:

  • Target Product Profile
  • Stability Issues
  • Packaging selection challenges
  • Commercialisation challenges
  • Regulatory considerations

About Your Workshop Host:

Thomas Österberg is Senior Manager, Biologics at Product & Process Development, Pfizer, Sweden. He has more than 20 years of experience from pharmaceutical research & development and has managed the pharmaceutical development of several marketed protein drugs and among them the first "albumin free" Factor VIII product (Refacto®). Thomas has also worked extensively with biopharmaceutical evaluation of drug candidates, drug delivery technology and life cycle management of protein therapeutics.

Thomas gives presentations and lectures widely in the healthcare industry and on a number of university courses in pharmaceutical development. Thomas has a PhD in Pharmaceutics, is a certified Six sigma black belt and holds an Associate Professor title in Pharmaceutical Technology. Thomas has published about 20 scientific papers and is the co-inventor of several patents.
 

Workshop agenda

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13:30

REGISTRATION & COFFEE

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14:00

WELCOME & INTRODUCTIONS

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14:10

QUALITY TARGET PROFILE

  • Different types of prefilled syringes
  • Rubber components
  • Syringability
  • Plunger movement
  • Filling under inert atmosphere and gas/liquid equilibrium
  • Dual chamber systems
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    15:30

    AFTERNOON TEA

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    16:00

    PHARMACEUTICAL FORMULATION

  • Freeze-drying of proteins in dual chamber systems
  • Manufacturing of drug product
  • Injection devices
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    17:00

    CLOSE OF WORKSHOP

    Crowne Plaza Hotel - St James

    Buckingham Gate 45/51
    London SW1E 6AF
    United Kingdom

    Crowne Plaza Hotel - St James

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